A Phase 1/2, Open-Label, Dose-Escalation, Safety Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors
Sponsor
Incyte Biosciences International Sàrl (Industry)
Overall Status
Completed
CT.gov ID
NCT02923349
Collaborator
(none)
87
8
1
28.8
10.9
0.4
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the safety and tolerability and assess preliminary efficacy of INCAGN01949 in subjects with advanced or metastatic solid tumors.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
87 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors
Actual Study Start Date
:
Oct 31, 2016
Actual Primary Completion Date
:
Mar 26, 2019
Actual Study Completion Date
:
Mar 26, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: INCAGN01949
|
Drug: INCAGN01949
Initial cohort dose of INCAGN01949 monotherapy at the protocol-defined starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose will be taken forward into expansion cohorts.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Treatment-related Adverse Events [From screening through 60 days after end of treatment, up to 11 months]
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Secondary Outcome Measures
- Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma [Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6]
To evaluate the Cmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
- Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949 [Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6]
To evaluate the AUC0-t of INCAGN01949 in subjects with advanced or metastatic solid tumors
- Objective Response Rate Per RECIST and Modified RECIST [Baseline and every 8 weeks,up to 11 months]
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
- Duration of Response Per RECIST and Modified RECIST [Baseline and every 8 weeks, up to 11 months]
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
- Progression-free Survival Per RECIST and Modified RECIST [Baseline and every 8 weeks, up to 11 months]
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
- Duration of Disease Control Per RECIST and Modified RECIST [Baseline and every 8 weeks, up to 11 months]
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
- Time to Maximum Concentration of INCAGN01949 in Plasma [Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6]
To evaluate the Tmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
- Summary of Trough Concentrations(Cmin) of INCAGN01949 [Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6]
To evaluate the Cmin of INCAGN01949 in subjects with advanced or metastatic solid tumors. Cmin is the minimum observed concentration of INCAGN1949
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
-
Subjects who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment. There is no limit to the number of prior treatment regimens.
-
Part 1: Subjects with advanced or metastatic solid tumors.
-
Part 2: Subjects with advanced or metastatic adenocarcinoma of the endometrium, ovarian cancer, renal cell carcinoma, melanoma, and non-small cell lung cancer.
-
Presence of measureable disease based on RECIST v1.1.
-
Eastern Cooperative Oncology Group performance status 0 or 1.
Exclusion Criteria:
-
Laboratory and medical history parameters not within the protocol-defined range.
-
Receipt of anticancer medications or investigational drugs within the protocol-defined intervals before the first administration of study drug.
-
Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior immunotherapy) and/or complications from prior surgical intervention before starting therapy.
-
Receipt of a live vaccine within 30 days of planned start of study drug.
-
Active autoimmune disease that required systemic treatment in the past.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rutgers, The State University of New Jersey | New Brunswick | New Jersey | United States | 08901 |
| 2 | New York University Clinical Cancer Center | New York | New York | United States | 10016 |
| 3 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
| 4 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 5 | Vall d'Hebron Institute of Oncology (VHIO) | Barcelona | Spain | 08035 | |
| 6 | University Hospital of Laussane (CHUV) | Lausanne | Switzerland | 1011 | |
| 7 | University College Hospital | London | United Kingdom | NW1 2PG | |
| 8 | University of Oxford | Oxford | United Kingdom | OX3 7LE |
Sponsors and Collaborators
- Incyte Biosciences International Sàrl
Investigators
- Study Director: John E. Janik, MD, Incyte Corporation
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Incyte Biosciences International Sàrl
ClinicalTrials.gov Identifier:
NCT02923349
Other Study ID Numbers:
- INCAGN 1949-101
First Posted:
Oct 4, 2016
Last Update Posted:
May 12, 2020
Last Verified:
May 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Incyte Biosciences International Sàrl
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The study was conducted at 4 different sites in US, 1 site in Switzerland,1 site in Spain and 2 sites in the United Kingdom. |
|---|---|
| Pre-assignment Detail | A total of 129 participants were screened for this study, of which 42 participants were screen failures and 87 participants were randomized to treatment. |
| Arm/Group Title | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors |
| Period Title: Overall Study | |||||||
| STARTED | 4 | 4 | 22 | 18 | 23 | 12 | 4 |
| COMPLETED | 0 | 0 | 5 | 2 | 4 | 5 | 1 |
| NOT COMPLETED | 4 | 4 | 17 | 16 | 19 | 7 | 3 |
Baseline Characteristics
| Arm/Group Title | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) | Total |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | Total of all reporting groups |
| Overall Participants | 4 | 4 | 22 | 18 | 23 | 12 | 4 | 87 |
| Age (years) [Geometric Mean (Standard Deviation) ] | ||||||||
| Geometric Mean (Standard Deviation) [years] |
54.3
(16.24)
|
63.8
(12.63)
|
56.8
(14.27)
|
58.9
(12.78)
|
58.1
(12.44)
|
61.3
(9.93)
|
52.8
(24.50)
|
58.2
(13.24)
|
| Sex: Female, Male (Count of Participants) | ||||||||
| Female |
2
50%
|
3
75%
|
14
63.6%
|
12
66.7%
|
17
73.9%
|
3
25%
|
2
50%
|
53
60.9%
|
| Male |
2
50%
|
1
25%
|
8
36.4%
|
6
33.3%
|
6
26.1%
|
9
75%
|
2
50%
|
34
39.1%
|
| Race/Ethnicity, Customized (participants) [Number] | ||||||||
| White/Caucasian |
4
100%
|
3
75%
|
19
86.4%
|
17
94.4%
|
23
100%
|
9
75%
|
4
100%
|
79
90.8%
|
| Asian |
0
0%
|
1
25%
|
2
9.1%
|
0
0%
|
0
0%
|
1
8.3%
|
0
0%
|
4
4.6%
|
| Other |
0
0%
|
0
0%
|
1
4.5%
|
1
5.6%
|
0
0%
|
0
0%
|
0
0%
|
2
2.3%
|
| Black/African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
16.7%
|
0
0%
|
2
2.3%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||||||
| Hispanic or Latino |
0
0%
|
0
0%
|
1
4.5%
|
1
5.6%
|
0
0%
|
1
8.3%
|
1
25%
|
4
4.6%
|
| Not Hispanic or Latino |
4
100%
|
4
100%
|
19
86.4%
|
16
88.9%
|
22
95.7%
|
11
91.7%
|
2
50%
|
78
89.7%
|
| Not Reported |
0
0%
|
0
0%
|
1
4.5%
|
1
5.6%
|
1
4.3%
|
0
0%
|
1
25%
|
4
4.6%
|
| Other |
0
0%
|
0
0%
|
1
4.5%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
1.1%
|
Outcome Measures
| Title | Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma |
|---|---|
| Description | To evaluate the Cmax of INCAGN01949 in subjects with advanced or metastatic solid tumors. |
| Time Frame | Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PK evaluable population will include all subjects who received at least 1 dose of INCAGN01949 and provided at least 1 post dose sample (1 PK measurement). |
| Arm/Group Title | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors |
| Measure Participants | 4 | 4 | 21 | 17 | 21 | 7 | 4 |
| Mean (Standard Deviation) [ng/ml] |
1630
(735)
|
5820
(324)
|
22300
(32800)
|
39200
(10300)
|
84900
(76700)
|
207000
(45500)
|
347000
(130000)
|
| Title | Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949 |
|---|---|
| Description | To evaluate the AUC0-t of INCAGN01949 in subjects with advanced or metastatic solid tumors |
| Time Frame | Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PK evaluable population will include all subjects who received at least 1 dose of INCAGN01949 and provided at least 1 post dose sample (1 PK measurement). |
| Arm/Group Title | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors |
| Measure Participants | 4 | 4 | 21 | 17 | 21 | 7 | 4 |
| cycle 1 |
185
(81.7)
|
904
(197)
|
2370
(841)
|
5400
(1820)
|
10000
(5600)
|
28300
(7720)
|
61600
(9130)
|
| cycle 6 |
427
(9.21)
|
5490
(1560)
|
10700
(6560)
|
| Title | Objective Response Rate Per RECIST and Modified RECIST |
|---|---|
| Description | ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination. |
| Time Frame | Baseline and every 8 weeks,up to 11 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCAGN01949. |
| Arm/Group Title | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors |
| Measure Participants | 4 | 4 | 22 | 18 | 23 | 12 | 4 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
8.3%
|
0
0%
|
| Title | Duration of Response Per RECIST and Modified RECIST |
|---|---|
| Description | ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination. |
| Time Frame | Baseline and every 8 weeks, up to 11 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set population included all subjects enrolled in the study who received at least 1 dose of INCAGN01949. Median was not estimable due to insufficient number of participants with response |
| Arm/Group Title | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Median (Full Range) [days] |
192
(192)
|
| Title | Progression-free Survival Per RECIST and Modified RECIST |
|---|---|
| Description | ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination. |
| Time Frame | Baseline and every 8 weeks, up to 11 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCAGN01949. |
| Arm/Group Title | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors |
| Measure Participants | 4 | 4 | 22 | 18 | 23 | 12 | 4 |
| Median (Full Range) [Days] |
57
(55)
|
47.5
(29)
|
54.0
(23)
|
56.0
(26)
|
52.0
(1)
|
125.0
(21)
|
46.5
(42)
|
| Title | Duration of Disease Control Per RECIST and Modified RECIST |
|---|---|
| Description | ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination. |
| Time Frame | Baseline and every 8 weeks, up to 11 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCAGN01949. Median was not estimable due to insufficient number of participants with CR, PR, and SD |
| Arm/Group Title | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors |
| Measure Participants | 1 | 1 | 8 | 7 | 3 | 7 | 0 |
| Median (Full Range) [Days] |
0
|
57
|
64
|
57
|
NA
|
120
|
| Title | Number of Participants With Treatment-related Adverse Events |
|---|---|
| Description | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment |
| Time Frame | From screening through 60 days after end of treatment, up to 11 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCAGN01949. |
| Arm/Group Title | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors |
| Measure Participants | 4 | 4 | 22 | 18 | 23 | 12 | 4 |
| Count of Participants [Participants] |
4
100%
|
4
100%
|
21
95.5%
|
17
94.4%
|
22
95.7%
|
11
91.7%
|
4
100%
|
| Title | Time to Maximum Concentration of INCAGN01949 in Plasma |
|---|---|
| Description | To evaluate the Tmax of INCAGN01949 in subjects with advanced or metastatic solid tumors. |
| Time Frame | Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PK evaluable population will include all subjects who received at least 1 dose of INCAGN01949 and provided at least 1 post dose sample (1 PK measurement). |
| Arm/Group Title | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors |
| Measure Participants | 4 | 4 | 21 | 17 | 21 | 7 | 4 |
| cycle 1 |
0.64
|
2.53
|
4.3
|
0.63
|
0.6
|
0.7
|
0.73
|
| cycle 6 |
0.78
|
0.63
|
0.61
|
| Title | Summary of Trough Concentrations(Cmin) of INCAGN01949 |
|---|---|
| Description | To evaluate the Cmin of INCAGN01949 in subjects with advanced or metastatic solid tumors. Cmin is the minimum observed concentration of INCAGN1949 |
| Time Frame | Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PK evaluable population will include all subjects who received at least 1 dose of INCAGN01949 and provided at least 1 post dose sample (1 PK measurement). |
| Arm/Group Title | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors |
| Measure Participants | 4 | 4 | 22 | 18 | 23 | 12 | 4 |
| cycle 2 |
303
(202)
|
1890
(1570)
|
3620
(1550)
|
8880
(4510)
|
17000
(8040)
|
41000
(13000)
|
117000
(19300)
|
| cycle 3 |
753
(163)
|
1520
(225)
|
5620
(3280)
|
14300
(7740)
|
29400
(18400)
|
77800
(27900)
|
163000
(32900)
|
| cycle 4 |
895
(80.2)
|
1780
(318)
|
5110
(2850)
|
17900
(13200)
|
42200
(28500)
|
84600
(17700)
|
282000
(165000)
|
| cycle 6 |
785
(39.6)
|
9150
(2420)
|
19600
(13100)
|
43400
(26500)
|
|||
| cycle 7 |
10200
(2190)
|
21600
(10600)
|
Adverse Events
| Time Frame | From screening through 60 days after end of treatment, up to 11 months | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||
| Arm/Group Title | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) | |||||||
| Arm/Group Description | INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | |||||||
All Cause Mortality |
||||||||||||||
| PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/4 (25%) | 0/4 (0%) | 2/22 (9.1%) | 4/18 (22.2%) | 2/23 (8.7%) | 3/12 (25%) | 0/4 (0%) | |||||||
Serious Adverse Events |
||||||||||||||
| PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/4 (25%) | 1/4 (25%) | 8/22 (36.4%) | 9/18 (50%) | 9/23 (39.1%) | 5/12 (41.7%) | 1/4 (25%) | |||||||
| Cardiac disorders | ||||||||||||||
| Ventricular tachycardia | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Abdominal pain | 0/4 (0%) | 0/4 (0%) | 1/22 (4.5%) | 0/18 (0%) | 1/23 (4.3%) | 2/12 (16.7%) | 0/4 (0%) | |||||||
| Abdominal pain upper | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Ascites | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Colitis | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 1/23 (4.3%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Diarrhoea | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 1/23 (4.3%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Intestinal obstruction | 0/4 (0%) | 0/4 (0%) | 1/22 (4.5%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Nausea | 0/4 (0%) | 0/4 (0%) | 1/22 (4.5%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Small intestinal obstruction | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 2/18 (11.1%) | 2/23 (8.7%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Vomiting | 0/4 (0%) | 0/4 (0%) | 1/22 (4.5%) | 1/18 (5.6%) | 1/23 (4.3%) | 0/12 (0%) | 0/4 (0%) | |||||||
| General disorders | ||||||||||||||
| General physical health deterioration | 0/4 (0%) | 0/4 (0%) | 1/22 (4.5%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Oedema | 0/4 (0%) | 0/4 (0%) | 1/22 (4.5%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Pain | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Pyrexia | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 1/23 (4.3%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Hepatobiliary disorders | ||||||||||||||
| Jaundice | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 1/4 (25%) | |||||||
| Jaundice cholestatic | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 1/23 (4.3%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Infections and infestations | ||||||||||||||
| Appendicitis | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 1/23 (4.3%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Lower respiratory tract infection | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Lower respiratory tract infection bacterial | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Myelitis | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 1/23 (4.3%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Pneumonia streptococcal | 0/4 (0%) | 1/4 (25%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Injury, poisoning and procedural complications | ||||||||||||||
| Spinal fracture | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Investigations | ||||||||||||||
| Blood bilirubin increased | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 1/23 (4.3%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Metabolism and nutrition disorders | ||||||||||||||
| Dehydration | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 1/23 (4.3%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| Arthralgia | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 1/23 (4.3%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Back pain | 0/4 (0%) | 0/4 (0%) | 1/22 (4.5%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||
| Cancer pain | 0/4 (0%) | 0/4 (0%) | 1/22 (4.5%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Malignant neoplasm progression | 1/4 (25%) | 0/4 (0%) | 1/22 (4.5%) | 1/18 (5.6%) | 2/23 (8.7%) | 3/12 (25%) | 0/4 (0%) | |||||||
| Tumour pain | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Nervous system disorders | ||||||||||||||
| Ataxia | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 1/23 (4.3%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Cauda equina syndrome | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Spinal cord compression | 0/4 (0%) | 0/4 (0%) | 1/22 (4.5%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Renal and urinary disorders | ||||||||||||||
| Acute kidney injury | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 1/23 (4.3%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Hydronephrosis | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 1/23 (4.3%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Urinary incontinence | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 1/23 (4.3%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Urinary tract pain | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Vascular disorders | ||||||||||||||
| Deep vein thrombosis | 0/4 (0%) | 0/4 (0%) | 1/22 (4.5%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Embolism | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 1/23 (4.3%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||
| PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/4 (100%) | 4/4 (100%) | 21/22 (95.5%) | 17/18 (94.4%) | 22/23 (95.7%) | 10/12 (83.3%) | 4/4 (100%) | |||||||
| Blood and lymphatic system disorders | ||||||||||||||
| Anaemia | 0/4 (0%) | 0/4 (0%) | 4/22 (18.2%) | 2/18 (11.1%) | 1/23 (4.3%) | 2/12 (16.7%) | 2/4 (50%) | |||||||
| Cardiac disorders | ||||||||||||||
| Sinus bradycardia | 0/4 (0%) | 1/4 (25%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Ventricular tachycardia | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Ear and labyrinth disorders | ||||||||||||||
| Tinnitus | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Endocrine disorders | ||||||||||||||
| Hypothyroidism | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 2/18 (11.1%) | 1/23 (4.3%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Abdominal distension | 0/4 (0%) | 1/4 (25%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Abdominal pain | 0/4 (0%) | 1/4 (25%) | 1/22 (4.5%) | 3/18 (16.7%) | 4/23 (17.4%) | 0/12 (0%) | 1/4 (25%) | |||||||
| Abdominal pain upper | 0/4 (0%) | 1/4 (25%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 1/4 (25%) | |||||||
| Ascites | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 1/23 (4.3%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Constipation | 1/4 (25%) | 1/4 (25%) | 4/22 (18.2%) | 6/18 (33.3%) | 4/23 (17.4%) | 1/12 (8.3%) | 1/4 (25%) | |||||||
| Diarrhoea | 1/4 (25%) | 0/4 (0%) | 3/22 (13.6%) | 4/18 (22.2%) | 3/23 (13%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Dry mouth | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Dyspepsia | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 1/4 (25%) | |||||||
| Dysphagia | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Epigastric discomfort | 0/4 (0%) | 0/4 (0%) | 1/22 (4.5%) | 1 | 2/18 (11.1%) | 1 | 0/23 (0%) | 1 | 0/12 (0%) | 1 | 0/4 (0%) | 1 | ||
| Gastrooesophageal reflux disease | 0/4 (0%) | 0/4 (0%) | 2/22 (9.1%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Nausea | 0/4 (0%) | 1/4 (25%) | 3/22 (13.6%) | 5 | 3/18 (16.7%) | 5 | 6/23 (26.1%) | 5 | 0/12 (0%) | 5 | 1/4 (25%) | 5 | ||
| Vomiting | 1/4 (25%) | 0/4 (0%) | 5/22 (22.7%) | 3/18 (16.7%) | 4/23 (17.4%) | 0/12 (0%) | 0/4 (0%) | |||||||
| General disorders | ||||||||||||||
| Asthenia | 0/4 (0%) | 0/4 (0%) | 2/22 (9.1%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Chills | 0/4 (0%) | 1/4 (25%) | 1/22 (4.5%) | 0/18 (0%) | 2/23 (8.7%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Early satiety | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 1/4 (25%) | |||||||
| Fatigue | 2/4 (50%) | 2/4 (50%) | 6/22 (27.3%) | 7/18 (38.9%) | 8/23 (34.8%) | 4/12 (33.3%) | 2/4 (50%) | |||||||
| Gait disturbance | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Influenza like illness | 0/4 (0%) | 1/4 (25%) | 1/22 (4.5%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Nodule | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Non-cardiac chest pain | 0/4 (0%) | 0/4 (0%) | 1/22 (4.5%) | 1/18 (5.6%) | 0/23 (0%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Oedema peripheral | 0/4 (0%) | 0/4 (0%) | 1/22 (4.5%) | 3/18 (16.7%) | 0/23 (0%) | 2/12 (16.7%) | 1/4 (25%) | |||||||
| Peripheral swelling | 0/4 (0%) | 0/4 (0%) | 2/22 (9.1%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Pyrexia | 0/4 (0%) | 2/4 (50%) | 1/22 (4.5%) | 0/18 (0%) | 2/23 (8.7%) | 1/12 (8.3%) | 1/4 (25%) | |||||||
| Hepatobiliary disorders | ||||||||||||||
| Cholangitis | 0/4 (0%) | 1/4 (25%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Immune system disorders | ||||||||||||||
| Seasonal allergy | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 2/23 (8.7%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Infections and infestations | ||||||||||||||
| Cellulitis | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Gastroenteritis | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Infectious pleural effusion | 0/4 (0%) | 1/4 (25%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Oral herpes | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Pneumonia | 0/4 (0%) | 0/4 (0%) | 1/22 (4.5%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Rash pustular | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Respiratory tract infection | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 1/4 (25%) | |||||||
| Skin infection | 0/4 (0%) | 0/4 (0%) | 2/22 (9.1%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Upper respiratory tract infection | 0/4 (0%) | 1/4 (25%) | 1/22 (4.5%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 1/4 (25%) | |||||||
| Urinary tract infection | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 2/18 (11.1%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Wound infection | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Injury, poisoning and procedural complications | ||||||||||||||
| Fall | 0/4 (0%) | 0/4 (0%) | 1/22 (4.5%) | 1/18 (5.6%) | 1/23 (4.3%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Joint injury | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Meniscus injury | 0/4 (0%) | 1/4 (25%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Rib fracture | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 1/4 (25%) | |||||||
| Spinal fracture | 0/4 (0%) | 1/4 (25%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Tooth fracture | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Investigations | ||||||||||||||
| Amylase increased | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 2/18 (11.1%) | 0/23 (0%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Aspartate aminotransferase increased | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 1/23 (4.3%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Blood alkaline phosphatase increased | 1/4 (25%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 2/12 (16.7%) | 1/4 (25%) | |||||||
| Blood bilirubin increased | 1/4 (25%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 2/12 (16.7%) | 0/4 (0%) | |||||||
| Blood creatinine increased | 1/4 (25%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 2/23 (8.7%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Blood lactate dehydrogenase increased | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Blood urea increased | 1/4 (25%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| C-reactive protein increased | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Electrocardiogram QT prolonged | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Lipase increased | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 1/23 (4.3%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Lymph node palpable | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 1/4 (25%) | |||||||
| Lymphocyte count decreased | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 2/22 (9.1%) | 2 | 0/18 (0%) | 0 | 1/23 (4.3%) | 1 | 0/12 (0%) | 0 | 1/4 (25%) | 1 |
| Platelet count decreased | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Weight decreased | 2/4 (50%) | 1/4 (25%) | 0/22 (0%) | 2/18 (11.1%) | 2/23 (8.7%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Weight increased | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 1/4 (25%) | |||||||
| Metabolism and nutrition disorders | ||||||||||||||
| Decreased appetite | 1/4 (25%) | 3/4 (75%) | 6/22 (27.3%) | 4/18 (22.2%) | 7/23 (30.4%) | 3/12 (25%) | 0/4 (0%) | |||||||
| Dehydration | 0/4 (0%) | 1/4 (25%) | 1/22 (4.5%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Hyperglycaemia | 0/4 (0%) | 1/4 (25%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Hypokalaemia | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 1/23 (4.3%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| Arthralgia | 0/4 (0%) | 3/4 (75%) | 3/22 (13.6%) | 1/18 (5.6%) | 1/23 (4.3%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Back pain | 1/4 (25%) | 0/4 (0%) | 3/22 (13.6%) | 2/18 (11.1%) | 5/23 (21.7%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Bone pain | 0/4 (0%) | 0/4 (0%) | 1/22 (4.5%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Fistula | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Flank pain | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Groin pain | 0/4 (0%) | 1/4 (25%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Musculoskeletal chest pain | 1/4 (25%) | 0/4 (0%) | 1/22 (4.5%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Musculoskeletal pain | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Myalgia | 1/4 (25%) | 2/4 (50%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Pain in extremity | 0/4 (0%) | 0/4 (0%) | 1/22 (4.5%) | 0/18 (0%) | 0/23 (0%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Nervous system disorders | ||||||||||||||
| Ataxia | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Dizziness | 0/4 (0%) | 0/4 (0%) | 1/22 (4.5%) | 1/18 (5.6%) | 1/23 (4.3%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Dysgeusia | 1/4 (25%) | 0/4 (0%) | 1/22 (4.5%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Hypoaesthesia | 0/4 (0%) | 0/4 (0%) | 2/22 (9.1%) | 0/18 (0%) | 1/23 (4.3%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Neuropathy peripheral | 0/4 (0%) | 0/4 (0%) | 1/22 (4.5%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Spinal cord compression | 1/4 (25%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Tremor | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Psychiatric disorders | ||||||||||||||
| Depression | 0/4 (0%) | 1/4 (25%) | 1/22 (4.5%) | 0/18 (0%) | 1/23 (4.3%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Hallucination | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Renal and urinary disorders | ||||||||||||||
| Haematuria | 0/4 (0%) | 0/4 (0%) | 1/22 (4.5%) | 1/18 (5.6%) | 1/23 (4.3%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Haemorrhage urinary tract | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 1/4 (25%) | |||||||
| Nocturia | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 1/4 (25%) | |||||||
| Urinary incontinence | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 1/23 (4.3%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Urinary retention | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Urinary tract obstruction | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Reproductive system and breast disorders | ||||||||||||||
| Vaginal haemorrhage | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| Cough | 0/4 (0%) | 1/4 (25%) | 4/22 (18.2%) | 5/18 (27.8%) | 1/23 (4.3%) | 1/12 (8.3%) | 1/4 (25%) | |||||||
| Dyspnoea | 1/4 (25%) | 2/4 (50%) | 2/22 (9.1%) | 3/18 (16.7%) | 3/23 (13%) | 2/12 (16.7%) | 2/4 (50%) | |||||||
| Dyspnoea exertional | 0/4 (0%) | 0/4 (0%) | 1/22 (4.5%) | 1/18 (5.6%) | 0/23 (0%) | 2/12 (16.7%) | 2/4 (50%) | |||||||
| Epistaxis | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 1/12 (8.3%) | 1/4 (25%) | |||||||
| Haemothorax | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Hypoxia | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Nasal congestion | 1/4 (25%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 1/23 (4.3%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Oropharyngeal pain | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Pleural effusion | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 2/23 (8.7%) | 0/12 (0%) | 1/4 (25%) | |||||||
| Productive cough | 0/4 (0%) | 1/4 (25%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 1/4 (25%) | |||||||
| Pulmonary embolism | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Rhinitis allergic | 0/4 (0%) | 1/4 (25%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Upper-airway cough syndrome | 0/4 (0%) | 0/4 (0%) | 1/22 (4.5%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Wheezing | 1/4 (25%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||
| Erythema | 1/4 (25%) | 0/4 (0%) | 1/22 (4.5%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Hyperhidrosis | 0/4 (0%) | 0/4 (0%) | 1/22 (4.5%) | 0/18 (0%) | 0/23 (0%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Night sweats | 0/4 (0%) | 0/4 (0%) | 2/22 (9.1%) | 0/18 (0%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Pruritus | 0/4 (0%) | 0/4 (0%) | 2/22 (9.1%) | 2/18 (11.1%) | 2/23 (8.7%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Pruritus generalised | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Rash | 0/4 (0%) | 0/4 (0%) | 2/22 (9.1%) | 2/18 (11.1%) | 1/23 (4.3%) | 0/12 (0%) | 1/4 (25%) | |||||||
| Rash maculo-papular | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 2/18 (11.1%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Tumour pruritus | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
| Vascular disorders | ||||||||||||||
| Deep vein thrombosis | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Hypertension | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 0/18 (0%) | 0/23 (0%) | 1/12 (8.3%) | 0/4 (0%) | |||||||
| Thrombophlebitis superficial | 0/4 (0%) | 0/4 (0%) | 0/22 (0%) | 1/18 (5.6%) | 0/23 (0%) | 0/12 (0%) | 0/4 (0%) | |||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Clinical Study Agreement
Results Point of Contact
| Name/Title | Incyte Biosciences International Sàrl |
|---|---|
| Organization | Incyte Corporation Call Centre |
| Phone | 8554633463 |
| RA@incyte.com |
Responsible Party:
Incyte Biosciences International Sàrl
ClinicalTrials.gov Identifier:
NCT02923349
Other Study ID Numbers:
- INCAGN 1949-101
First Posted:
Oct 4, 2016
Last Update Posted:
May 12, 2020
Last Verified:
May 1, 2020