A Phase 1/2 Multicenter Dose Escalation and Expansion Study Of NKTR-214 In Subjects With Locally Advanced Or Metastatic Solid Tumors
Sponsor
Nektar Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT02869295
Collaborator
(none)
28
3
1
35
9.3
0.3
Study Details
Study Description
Brief Summary
This is a first in human, open-label, sequential dose escalation and expansion Phase 1 study of NKTR-214 in adult patients with locally advanced or metastatic solid tumors.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
28 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Multicenter, Dose Escalation And Expansion Study Of NKTR-214 In Subjects With Locally Advanced Or Metastatic Solid Tumor Malignancies
Actual Study Start Date
:
Dec 1, 2015
Actual Primary Completion Date
:
Oct 31, 2018
Actual Study Completion Date
:
Oct 31, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: NKTR-214 Dose Escalation This is a first in human, open-label, sequential dose escalation and expansion Phase 1 study of NKTR--214 in adult patients with locally advanced and metastatic solid tumors. The Phase 1 stage of the study is designed as an open-label dose escalation trial of NKTR--214 in participants with locally advanced or metastatic solid tumors. The goal of the dose escalation stage of the study is to find the recommended phase 2 dose, to evaluate the efficacy of NKTR--214 by assessing the objective response rate and to evaluate the safety of NKTR-214. Immunological biomarkers in plasma and tumor samples will also be measured. |
Drug: NKTR-214
Participants in the dose escalation cohorts will be treated every 21 days (q21d) or every 14 days (q14d) until tumor progression.
|
Outcome Measures
Primary Outcome Measures
- Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) [30 days after last dose, approximately 533 days]
This outcome quantifies the number and types of adverse events associated with NKTR-214.
- Tolerability of NKTR-214 as Evaluated by Incidence of Dose Limiting Toxicities (DLTs) [30 days after last dose, up to 533 days]
The data below reflects the incidence of Dose Limiting Toxicity Events observed in this trial.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor.
-
Received 1 or 2 prior lines of therapy.
-
Life expectancy >12 weeks.
-
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
-
Measurable disease per RECIST v1.1.
-
Demonstrated adequate organ function within 14 days of treatment initiation.
-
Subjects must be recovered from the effects of any prior chemotherapy, immunotherapy, other prior system anticancer therapy, radiotherapy or surgery.
-
Women of childbearing potential must agree to use highly effective methods of birth control.
-
All participants must agree to use double barrier contraception during study participation and for at least 2 months after the last dose of study drug.
-
Additional criteria may apply.
Exclusion Criteria:
-
Use of an investigational agent or an investigational device within 28 days before administration of first dose of NKTR-214.
-
Females who are pregnant or breastfeeding.
-
Participants who have an active autoimmune disease requiring systemic treatment within the past 3 months or have a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents.
-
Active central nervous system (CNS) metastases.
-
Prior surgery or radiotherapy within 14 days of therapy.
-
Participants who have had < 28 days since the last chemotherapy, immunotherapy, biological therapy, or < 14 days from approved tyrosine kinase inhibitor (TKI) therapy (sunitinib, sorafenib, vemurafenib, dabrafenib, cobimetinib), or systemic or inhaled steroid therapy at doses greater than 10mg of prednisone or equivalent before administration of the first dose of study medication.
-
Participants' inability to adhere to or tolerate protocol or study procedures.
-
Additional criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigator Site - New Haven | New Haven | Connecticut | United States | 06473 |
| 2 | Investigator Site - Portland | Portland | Oregon | United States | 97213 |
| 3 | Investigator Site - Houston | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Nektar Therapeutics
Investigators
None specified.Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Nektar Therapeutics
ClinicalTrials.gov Identifier:
NCT02869295
Other Study ID Numbers:
- 15-214-01
- 2016-001134-10
First Posted:
Aug 16, 2016
Last Update Posted:
Jul 29, 2021
Last Verified:
Jul 1, 2021
Keywords provided by Nektar Therapeutics
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | The Sponsor discontinued enrollment in order to allow the clinical development program for NKTR-214 to continue with other studies in which NKTR-214 was administered in combination with checkpoint inhibitors, based on biomarker analysis, which showed infiltration of immune cells within tumor tissue. |
| Arm/Group Title | NKTR-214 0.003 mg/kg q21d | NKTR-214 0.006 mg/kg q21d | NKTR-214 0.006 mg/kg q14d | NKTR-214 0.009 mg/kg q21d | NKTR-214 0.012 mg/kg q21d |
|---|---|---|---|---|---|
| Arm/Group Description | This group will be given NKTR-214 at a dose of 0.003 mg/kg every 21 days | This group will be given NKTR-214 at a dose of 0.006 mg/kg every 21 days | This group will be given NKTR-214 at a dose of 0.006 mg/kg every 14 days | This group will be given NKTR-214 at a dose of 0.009 mg/kg every 21 days | This group will be given NKTR-214 at a dose of 0.012 mg/kg every 21 days |
| Period Title: Overall Study | |||||
| STARTED | 4 | 11 | 6 | 6 | 1 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 4 | 11 | 6 | 6 | 1 |
Baseline Characteristics
| Arm/Group Title | NKTR-214 0.003 mg/kg q21d | NKTR-214 0.006 mg/kg q21d | NKTR-214 0.006 mg/kg q14d | NKTR-214 0.009 mg/kg q21d | NKTR-214 0.012 mg/kg q21d | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | NKTR-214 given at a dose of 0.003 mg/kg every 21 days | NKTR-214 given at a dose of 0.006 mg/kg every 21 days | NKTR-214 given at a dose of 0.006 mg/kg every 14 days | NKTR-214 given at a dose of 0.009 mg/kg every 21 days | NKTR-214 given at a dose of 0.012 mg/kg every 21 days | Total of all reporting groups |
| Overall Participants | 4 | 11 | 6 | 6 | 1 | 28 |
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [years] |
54.8
(14.17)
|
56.5
(11.59)
|
62.0
(10.16)
|
60.8
(5.00)
|
43.0
(NA)
|
57.9
(10.58)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
1
25%
|
6
54.5%
|
2
33.3%
|
2
33.3%
|
0
0%
|
11
39.3%
|
| Male |
3
75%
|
5
45.5%
|
4
66.7%
|
4
66.7%
|
1
100%
|
17
60.7%
|
| Race (NIH/OMB) (Count of Participants) | ||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
1
9.1%
|
0
0%
|
0
0%
|
0
0%
|
1
3.6%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
2
18.2%
|
0
0%
|
0
0%
|
0
0%
|
2
7.1%
|
| White |
4
100%
|
8
72.7%
|
6
100%
|
6
100%
|
1
100%
|
25
89.3%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status, n(%) (Count of Participants) | ||||||
| 0 |
3
75%
|
7
63.6%
|
2
33.3%
|
3
50%
|
1
100%
|
16
57.1%
|
| 1 |
1
25%
|
4
36.4%
|
4
66.7%
|
3
50%
|
0
0%
|
12
42.9%
|
| Status Enrollment (Count of Participants) | ||||||
| Metastatic |
4
100%
|
9
81.8%
|
6
100%
|
6
100%
|
1
100%
|
26
92.9%
|
| Locally Recurrent |
0
0%
|
2
18.2%
|
0
0%
|
0
0%
|
0
0%
|
2
7.1%
|
| Lines of Prior Systemic Cancer Therapy (number of lines of therapy) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [number of lines of therapy] |
5.3
(4.72)
|
1.8
(1.25)
|
3.0
(2.53)
|
3.3
(2.34)
|
1
(NA)
|
2.9
(2.59)
|
| Prior Therapies (participants) [Number] | ||||||
| # of Participants with previous Chemotherapy |
3
75%
|
2
18.2%
|
4
66.7%
|
1
16.7%
|
0
0%
|
10
35.7%
|
| # of Participants with previous Targeted Therapy |
3
75%
|
8
72.7%
|
2
33.3%
|
3
50%
|
0
0%
|
14
50%
|
| # of Participants with previous Immune Checkpoint Inhibitor (ICI) Only |
3
75%
|
4
36.4%
|
2
33.3%
|
6
100%
|
1
100%
|
16
57.1%
|
| # of Participants with previous ICI and other immunotherapy |
1
25%
|
1
9.1%
|
0
0%
|
4
66.7%
|
0
0%
|
6
21.4%
|
Outcome Measures
| Title | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) |
|---|---|
| Description | This outcome quantifies the number and types of adverse events associated with NKTR-214. |
| Time Frame | 30 days after last dose, approximately 533 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | NKTR-214 0.003 mg/kg q21d | NKTR-214 0.006 mg/kg q21d | NKTR-214 0.006 mg/kg q14d | NKTR-214 0.009 mg/kg q21d | NKTR-214 0.012 mg/kg q21d |
|---|---|---|---|---|---|
| Arm/Group Description | NKTR-214 given at a dose of 0.003 mg/kg every 21 days | NKTR-214 given at a dose of 0.006 mg/kg every 21 days | NKTR-214 given at a dose of 0.006 mg/kg every 14 days | NKTR-214 given at a dose of 0.009 mg/kg every 21 days | NKTR-214 given at a dose of 0.012 mg/kg every 21 days |
| Measure Participants | 4 | 11 | 6 | 6 | 1 |
| # of Events of Hypotension Grade 1-2 |
2
|
8
|
2
|
1
|
0
|
| # of Events of Syncope Grade 3-5 |
0
|
1
|
1
|
0
|
1
|
| # of Events of Headache Grade 1-2 |
3
|
2
|
1
|
2
|
0
|
| # of Events of Headache Grade 3-5 |
0
|
1
|
0
|
1
|
0
|
| # of Events of Anemia Grade 1-2 |
2
|
1
|
0
|
1
|
0
|
| # of Events of Anemia Grade 3-5 |
0
|
1
|
0
|
1
|
0
|
| # of Events of Metastases to Central Nervous System Grade 3-5 |
0
|
2
|
0
|
1
|
0
|
| # of Events of Constipation Grade 1-2 |
2
|
3
|
2
|
1
|
0
|
| # of Events of Constipation Grade 3-5 |
1
|
0
|
0
|
0
|
0
|
| # of Events of Peripheral Edema Grade 1-2 |
0
|
4
|
1
|
1
|
0
|
| # of Events of Peripheral Edema Grade 3-5 |
0
|
1
|
0
|
0
|
0
|
| # of Events of Abdominal Pain Grade 1-2 |
1
|
1
|
0
|
0
|
0
|
| # of Events of Abdominal pain Grade 3-5 |
0
|
0
|
2
|
0
|
0
|
| # of Events of Pleural Effusion Grade 1-2 |
1
|
2
|
0
|
1
|
0
|
| # of Events of Pleural Effusion Grade 3-5 |
1
|
0
|
0
|
0
|
0
|
| # of Events of Confusional State Grade 1-2 |
0
|
0
|
2
|
0
|
0
|
| # of Events of Confusional State Grade 3-5 |
0
|
1
|
0
|
0
|
0
|
| # of Events of Infusion Related Reaction Grade 1-2 |
0
|
1
|
0
|
0
|
0
|
| # of Events of Infusion Related Reaction Grade 3-5 |
0
|
0
|
0
|
1
|
0
|
| # of Events of Presyncope Grade 1-2 |
0
|
1
|
0
|
0
|
0
|
| # of Events of Presyncope Grade 3-5 |
0
|
1
|
0
|
0
|
0
|
| # of Events of Brain Edema Grade 3-5 |
0
|
1
|
0
|
0
|
0
|
| # of Events of Disease Progression Grade 3-5 |
0
|
0
|
1
|
0
|
0
|
| # of Events of Gastroduodenal Hemorrhage Grade 3-5 |
0
|
1
|
0
|
0
|
0
|
| # of Events of Hemiparesis Grade 3-5 |
0
|
1
|
0
|
0
|
0
|
| # of Events of Hypovolemic Shock Grade 3-5 |
0
|
0
|
0
|
1
|
0
|
| # of Events of Lipase Increased Grade 3-5 |
1
|
0
|
0
|
0
|
0
|
| # of Events of Liver Function Test Abnormal Grade 3-5 |
0
|
0
|
0
|
1
|
0
|
| # of Events of Lower Gastrointestinal Hemorrhage Grade 3-5 |
0
|
0
|
1
|
0
|
0
|
| # of Events of Metastases to Meninges Grade 3-5 |
0
|
1
|
0
|
0
|
0
|
| # of Events of Sepsis Grade 3-5 |
0
|
0
|
1
|
0
|
0
|
| # of Events of Fatigue Grade 1-2 |
3
|
9
|
5
|
5
|
1
|
| # of Events of Flu-Like Symptoms Grade 1-2 |
3
|
8
|
4
|
5
|
0
|
| # of Events of Pruritus Grade 1-2 |
2
|
7
|
5
|
4
|
1
|
| # of Events of Decreased Appetite Grade 1-2 |
1
|
6
|
4
|
4
|
0
|
| # of Events of Rash Grade 1-2 |
3
|
6
|
4
|
2
|
0
|
| # of Events of Arthralgia Grade 1-2 |
1
|
3
|
5
|
2
|
1
|
| # of Events of Cough Grade 1-2 |
1
|
5
|
2
|
3
|
1
|
| # of Events of Nausea Grade 1-2 |
3
|
3
|
3
|
2
|
0
|
| # of Events of Diarrhea Grade 1-2 |
3
|
2
|
1
|
3
|
0
|
| # of Events of Dyspnea Grade 1-2 |
3
|
4
|
1
|
0
|
0
|
| # of Events of Nasal Congestion Grade 1-2 |
1
|
2
|
2
|
3
|
0
|
| # of Events of Dizziness Grade 1-2 |
2
|
3
|
1
|
1
|
0
|
| # of Events of Myalgia Grade 1-2 |
0
|
3
|
1
|
2
|
0
|
| # of Events of Vomiting Grade 1-2 |
1
|
2
|
2
|
1
|
0
|
| # of Events of Weight Decreased Grade 1-2 |
2
|
1
|
0
|
2
|
0
|
| # of Events of Flushing Grade 1-2 |
0
|
1
|
2
|
1
|
0
|
| # of Event of Anxiety Grade 1-2 |
1
|
1
|
0
|
1
|
0
|
| # of Events of Blood creatine increased Grade 1-2 |
0
|
1
|
1
|
1
|
0
|
| # of Events of Cytokine Release Syndrome Grade 1-2 |
0
|
0
|
0
|
2
|
1
|
| # of Events of Dry Skin Grade 1-2 |
1
|
2
|
0
|
0
|
0
|
| # of Events of Dyspepsia Grade 1-2 |
0
|
0
|
1
|
1
|
1
|
| # of Events of Generalized edema Grade 1-2 |
0
|
1
|
1
|
0
|
1
|
| # of Events of Muscular Weakness Grade 1-2 |
1
|
1
|
1
|
0
|
0
|
| # of Events of Oropharyngeal Pain Grade 1-2 |
1
|
2
|
0
|
0
|
0
|
| # of Events of Pain Extremity Grade 1-2 |
0
|
1
|
1
|
1
|
0
|
| # of Events of Hypotension Grade 3-5 |
0
|
1
|
2
|
1
|
1
|
| Title | Tolerability of NKTR-214 as Evaluated by Incidence of Dose Limiting Toxicities (DLTs) |
|---|---|
| Description | The data below reflects the incidence of Dose Limiting Toxicity Events observed in this trial. |
| Time Frame | 30 days after last dose, up to 533 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | NKTR-214 0.003 mg/kg q21d | NKTR-214 0.006 mg/kg q21d | NKTR-214 0.006 mg/kg q14d | NKTR-214 0.009 mg/kg q21d | NKTR-214 0.012 mg/kg q21d |
|---|---|---|---|---|---|
| Arm/Group Description | NKTR-214 given at a dose of 0.003 mg/kg every 21 days | NKTR-214 given at a dose of 0.006 mg/kg every 21 days | NKTR-214 given at a dose of 0.006 mg/kg every 14 days | NKTR-214 given at a dose of 0.009 mg/kg every 21 days | NKTR-214 given at a dose of 0.012 mg/kg every 21 days |
| Measure Participants | 4 | 11 | 6 | 6 | 1 |
| # of Events of Grade 3 Hypotension |
0
|
0
|
0
|
0
|
1
|
| # of Events of Grade 3 Syncope |
0
|
0
|
0
|
0
|
1
|
Adverse Events
| Time Frame | Adverse event data was monitored throughout the course of the period up to 30 days after the patient received the last dose, up to 533 days. | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | NKTR-214 0.003 mg/kg q21d | NKTR-214 0.006 mg/kg q21d | NKTR-214 0.006 mg/kg q14d | NKTR-214 0.009 mg/kg q21d | NKTR-214 0.012 mg/kg q21d | |||||
| Arm/Group Description | NKTR-214 given at a dose of 0.003 mg/kg every 21 days | NKTR-214 given at a dose of 0.006 mg/kg every 21 days | NKTR-214 given at a dose of 0.006 mg/kg every 14 days | NKTR-214 given at a dose of 0.009 mg/kg every 21 days | NKTR-214 given at a dose of 0.012 mg/kg every 21 days | |||||
All Cause Mortality |
||||||||||
| NKTR-214 0.003 mg/kg q21d | NKTR-214 0.006 mg/kg q21d | NKTR-214 0.006 mg/kg q14d | NKTR-214 0.009 mg/kg q21d | NKTR-214 0.012 mg/kg q21d | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/4 (50%) | 3/11 (27.3%) | 2/6 (33.3%) | 1/6 (16.7%) | 0/1 (0%) | |||||
Serious Adverse Events |
||||||||||
| NKTR-214 0.003 mg/kg q21d | NKTR-214 0.006 mg/kg q21d | NKTR-214 0.006 mg/kg q14d | NKTR-214 0.009 mg/kg q21d | NKTR-214 0.012 mg/kg q21d | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/4 (50%) | 5/11 (45.5%) | 4/6 (66.7%) | 3/6 (50%) | 1/1 (100%) | |||||
| Cardiac disorders | ||||||||||
| Syncope | 0/4 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/1 (100%) | |||||
| Anemia | 0/4 (0%) | 0/11 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | |||||
| Atrial Fibrillation | 0/4 (0%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | |||||
| Hypotension | 0/4 (0%) | 2/11 (18.2%) | 2/6 (33.3%) | 1/6 (16.7%) | 1/1 (100%) | |||||
| Gastrointestinal disorders | ||||||||||
| Constipation | 1/4 (25%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | |||||
| Gastroduodenal Hemorrhage | 0/4 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | |||||
| Lower Gastrointestinal Hemorrhage | 0/4 (0%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | |||||
| General disorders | ||||||||||
| Abdominal Pain | 0/4 (0%) | 0/11 (0%) | 2/6 (33.3%) | 0/6 (0%) | 0/1 (0%) | |||||
| Disease Progression | 0/4 (0%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | |||||
| Hypersensitivity | 0/4 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | |||||
| Hepatobiliary disorders | ||||||||||
| Ascites | 0/4 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | |||||
| Liver Function Test Abnormal | 0/4 (0%) | 0/11 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | |||||
| Infections and infestations | ||||||||||
| Sepsis | 0/4 (0%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | |||||
| Cytokine Release Syndrome | 0/4 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 1/1 (100%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Infusion Related Reaction | 0/4 (0%) | 0/11 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Lipase Increased | 1/4 (25%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Humerus Fracture | 0/4 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | |||||
| Nervous system disorders | ||||||||||
| Metastases to Central Nervous System | 0/4 (0%) | 2/11 (18.2%) | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Pleural Effusion | 2/4 (50%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| NKTR-214 0.003 mg/kg q21d | NKTR-214 0.006 mg/kg q21d | NKTR-214 0.006 mg/kg q14d | NKTR-214 0.009 mg/kg q21d | NKTR-214 0.012 mg/kg q21d | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/4 (100%) | 11/11 (100%) | 6/6 (100%) | 6/6 (100%) | 1/1 (100%) | |||||
| Cardiac disorders | ||||||||||
| Hypotension Grade 1-2 | 2/4 (50%) | 8/11 (72.7%) | 2/6 (33.3%) | 1/6 (16.7%) | 0/1 (0%) | |||||
| Anemia Grade 1-2 | 2/4 (50%) | 1/11 (9.1%) | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | |||||
| Peripheral Edema Grade 1-2 | 0/4 (0%) | 4/11 (36.4%) | 1/6 (16.7%) | 1/6 (16.7%) | 0/1 (0%) | |||||
| Presyncope Grade 1-2 | 0/4 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | |||||
| Fatigue Grade 1-2 | 3/4 (75%) | 9/11 (81.8%) | 5/6 (83.3%) | 5/6 (83.3%) | 1/1 (100%) | |||||
| Syncope Grade 3-5 | 0/4 (0%) | 1/11 (9.1%) | 1/6 (16.7%) | 0/6 (0%) | 1/1 (100%) | |||||
| Anemia Grade 3-5 | 0/4 (0%) | 1/11 (9.1%) | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | |||||
| Peripheral Edema Grade 3-5 | 0/4 (0%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | |||||
| Presyncope Grade 3-5 | 0/4 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | |||||
| Hypotension Grade 3-5 | 0/4 (0%) | 1/11 (9.1%) | 2/6 (33.3%) | 1/6 (16.7%) | 1/1 (100%) | |||||
| Gastrointestinal disorders | ||||||||||
| Constipation Grade 1-2 | 2/4 (50%) | 3/11 (27.3%) | 2/6 (33.3%) | 1/6 (16.7%) | 0/1 (0%) | |||||
| Nausea Grade 1-2 | 3/4 (75%) | 3/11 (27.3%) | 3/6 (50%) | 2/6 (33.3%) | 0/1 (0%) | |||||
| Diarrhea Grade 1-2 | 3/4 (75%) | 2/11 (18.2%) | 1/6 (16.7%) | 3/6 (50%) | 0/1 (0%) | |||||
| Vomiting Grade 1-2 | 1/4 (25%) | 2/11 (18.2%) | 2/6 (33.3%) | 1/6 (16.7%) | 0/1 (0%) | |||||
| Dyspepsia Grade 1-2 | 0/4 (0%) | 0/11 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 1/1 (100%) | |||||
| Constipation Grade 3-5 | 1/4 (25%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | |||||
| Gastroduodenal Hemorrhage Grade 3-5 | 0/4 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | |||||
| Hemiparesis Grade 3-5 | 0/4 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | |||||
| Lower Gastrointestinal Hemorrhage Grade 3-5 | 0/4 (0%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | |||||
| General disorders | ||||||||||
| Abdominal Pain Grade 1-2 | 1/4 (25%) | 1/11 (9.1%) | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | |||||
| Fatigue Grade 1-2 | 3/4 (75%) | 9/11 (81.8%) | 5/6 (83.3%) | 5/6 (83.3%) | 1/1 (100%) | |||||
| Decreased Appetite Grade 1-2 | 1/4 (25%) | 6/11 (54.5%) | 4/6 (66.7%) | 4/6 (66.7%) | 0/1 (0%) | |||||
| Arthralgia Grade 1-2 | 1/4 (25%) | 3/11 (27.3%) | 5/6 (83.3%) | 2/6 (33.3%) | 1/1 (100%) | |||||
| Cough Grade 1-2 | 1/4 (25%) | 5/11 (45.5%) | 2/6 (33.3%) | 3/6 (50%) | 1/1 (100%) | |||||
| Dizziness Grade 1-2 | 2/4 (50%) | 3/11 (27.3%) | 1/6 (16.7%) | 1/6 (16.7%) | 0/1 (0%) | |||||
| Myalgia Grade 1-2 | 0/4 (0%) | 3/11 (27.3%) | 1/6 (16.7%) | 2/6 (33.3%) | 0/1 (0%) | |||||
| Weight Decreased Grade 1-2 | 2/4 (50%) | 1/11 (9.1%) | 0/6 (0%) | 2/6 (33.3%) | 0/1 (0%) | |||||
| Flushing Grade 1-2 | 0/4 (0%) | 1/11 (9.1%) | 2/6 (33.3%) | 1/6 (16.7%) | 0/1 (0%) | |||||
| Generalized Edema Grade 1-2 | 0/4 (0%) | 1/11 (9.1%) | 1/6 (16.7%) | 0/6 (0%) | 1/1 (100%) | |||||
| Oropharyngeal Pain | 1/4 (25%) | 2/11 (18.2%) | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | |||||
| Pain Extremity Grade 1-2 | 0/4 (0%) | 1/11 (9.1%) | 1/6 (16.7%) | 1/6 (16.7%) | 0/1 (0%) | |||||
| Headache Grade 3-5 | 0/4 (0%) | 1/11 (9.1%) | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | |||||
| Abdominal Pain Grade 3-5 | 0/4 (0%) | 0/11 (0%) | 2/6 (33.3%) | 0/6 (0%) | 0/1 (0%) | |||||
| Disease Progression Grade 3-5 | 0/4 (0%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | |||||
| Metastases to Meninges Grade 3-5 | 0/4 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | |||||
| Infections and infestations | ||||||||||
| Flu-Like Symptoms Grade 1-2 | 3/4 (75%) | 8/11 (72.7%) | 4/6 (66.7%) | 5/6 (83.3%) | 0/1 (0%) | |||||
| Cytokine Release Syndrome Grade 1-2 | 0/4 (0%) | 0/11 (0%) | 0/6 (0%) | 2/6 (33.3%) | 1/1 (100%) | |||||
| Sepsis Grade 3-5 | 0/4 (0%) | 0/11 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Infusion Related Reaction Grade 1-2 | 0/4 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | |||||
| Infusion Related Reaction Grade 3-5 | 0/4 (0%) | 0/11 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Blood creatine increased Grade 1-2 | 0/4 (0%) | 1/11 (9.1%) | 1/6 (16.7%) | 1/6 (16.7%) | 0/1 (0%) | |||||
| Hypovolemic Shock Grade 3-5 | 0/4 (0%) | 0/11 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | |||||
| Lipase Increased Grade 3-5 | 1/4 (25%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | |||||
| Liver Function Test Abnormal Grade 3-5 | 0/4 (0%) | 0/11 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Muscular Weakness Grade 1-2 | 1/4 (25%) | 1/11 (9.1%) | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | |||||
| Nervous system disorders | ||||||||||
| Headache Grade 1-2 | 3/4 (75%) | 2/11 (18.2%) | 1/6 (16.7%) | 2/6 (33.3%) | 0/1 (0%) | |||||
| Confusional State Grade 1-2 | 0/4 (0%) | 0/11 (0%) | 2/6 (33.3%) | 0/6 (0%) | 0/1 (0%) | |||||
| Anxiety Grade 1-2 | 1/4 (25%) | 1/11 (9.1%) | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | |||||
| Metastases to Central Nervous System Grade 3-5 | 0/4 (0%) | 2/11 (18.2%) | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | |||||
| Confusional State Grade 3-5 | 0/4 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | |||||
| Brain Edema Grade 3-5 | 0/4 (0%) | 1/11 (9.1%) | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Pleural Effusion Grade 1-2 | 1/4 (25%) | 2/11 (18.2%) | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | |||||
| Dyspnea Grade 1-2 | 3/4 (75%) | 4/11 (36.4%) | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | |||||
| Nasal Congestion Grade 1-2 | 1/4 (25%) | 2/11 (18.2%) | 2/6 (33.3%) | 3/6 (50%) | 0/1 (0%) | |||||
| Pleural Effusion Grade 3-5 | 1/4 (25%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Pruritus Grade 1-2 | 2/4 (50%) | 7/11 (63.6%) | 5/6 (83.3%) | 4/6 (66.7%) | 1/1 (100%) | |||||
| Rash Grade 1-2 | 3/4 (75%) | 6/11 (54.5%) | 4/6 (66.7%) | 2/6 (33.3%) | 0/1 (0%) | |||||
| Dry Skin Grade 1-2 | 1/4 (25%) | 2/11 (18.2%) | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There are restrictions to the PI's rights to discuss or publish trial results.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Nektar Therapeutics |
| Phone | 415-482-5300 |
| medicalaffairs@nektar.com |
Responsible Party:
Nektar Therapeutics
ClinicalTrials.gov Identifier:
NCT02869295
Other Study ID Numbers:
- 15-214-01
- 2016-001134-10
First Posted:
Aug 16, 2016
Last Update Posted:
Jul 29, 2021
Last Verified:
Jul 1, 2021