An Extension Study of NKTR-102 in Cancer Patients Previously Enrolled in NKTR-102 Studies
Sponsor
Nektar Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT01457118
Collaborator
(none)
27
7
1
73
3.9
0.1
Study Details
Study Description
Brief Summary
The study objective of this open label, multicenter study is to provide access to NKTR-102 treatment to subjects previously enrolled in a NKTR-102 study who are without signs of disease progression since receiving NKTR-102.
In addition the study will evaluate the safety of continued exposure to NKTR-102, observe disease status and survival status in subjects receiving NKTR-102, and evaluate the efficacy of NKTR-102 in subjects with advanced or metastatic solid tumors.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
27 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Multicenter, Extension Study of NKTR-102 in Subjects Previously Enrolled in NKTR-102 Studies
Actual Study Start Date
:
Oct 1, 2011
Actual Primary Completion Date
:
Aug 1, 2017
Actual Study Completion Date
:
Nov 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: NKTR-102
|
Drug: NKTR-102 145 mg/m2
A 90 minute IV infusion of 145 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.
Drug: NKTR-102 120 mg/m2
A 90 minute IV infusion of 120 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.
Drug: NKTR-102 95 mg/m2
A 90 minute IV infusion of 95 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.
Drug: NKTR-102 50 mg/m2
A 90 minute IV infusion of 50 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.
|
Outcome Measures
Primary Outcome Measures
- Length of Exposure to NKTR-102 [Screening, Every 21 day cycle of treatment and Quarterly Follow-up]
To provide access to NKTR-102 to subjects who previously received NKTR-102 in a clinical trial and were without signs of disease progression since receiving NKTR-102.
Secondary Outcome Measures
- Adverse Events [Screening, Every 21 day cycle of treatment and Quarterly Follow-up]
To evaluate the safety of continued exposure to NKTR-102.
- Disease Status [Screening, Every 21 day cycle of treatment and Quarterly Follow-up]
To observe disease status and survival status in subjects receiving NKTR-102.
- Efficacy of NKTR-102 [Screening, Every 21 day cycle of treatment and Quarterly Follow-up]
To evaluate the efficacy of NKTR-102 in subjects with advanced or metastatic solid tumors.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion:
-
Received prior treatment with NKTR-102
-
Free of disease progression since receiving NKTR-102
-
Adequate bone marrow and organ function
-
Treatment with NKTR-102 in the extension study to begin within 8 weeks after receipt of their of last dose of NKTR-102
-
Agree to use adequate contraception
Exclusion:
-
Treatment with other anti-cancer therapy between the last dose of NKTR-102 in the prior study and before first dose of NKTR-102 in the extension study
-
A toxicity that requires a 3rd dose reduction after taking NKTR-102 or are scheduled to receive a dose < 70 mg/m2 upon entry into this study
-
Pregnancy or lactation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigator Site - Los Angeles | Los Angeles | California | United States | 90033 |
| 2 | Investigator Site - San Francisco | San Francisco | California | United States | 94143 |
| 3 | Investigator Site - Whittier | Whittier | California | United States | 90603 |
| 4 | Investigator Site - Minneapolis | Minneapolis | Minnesota | United States | 55455 |
| 5 | Investigator Site - Cleveland | Cleveland | Ohio | United States | 44106 |
| 6 | Investigator Site - Bruxelles | Bruxelles | Belgium | ||
| 7 | Investigator Site - Liege | Liege | Belgium | 4000 |
Sponsors and Collaborators
- Nektar Therapeutics
Investigators
- Study Director: Study Director, Nektar Therapeutics
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Nektar Therapeutics
ClinicalTrials.gov Identifier:
NCT01457118
Other Study ID Numbers:
- 11-PIR-09
First Posted:
Oct 21, 2011
Last Update Posted:
Jul 12, 2021
Last Verified:
Jul 1, 2021
Keywords provided by Nektar Therapeutics
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Subjects were assessed for eligibility following completion of NKTR-102 treatment on a prior NKTR-102 clinical study. The trials from which the subjects were previously enrolled in are listed below. NCT00856375 - 1 patient NCT00806156 - 1 patient NCT01492101 - 1 patient NCT00802945 - 2 patients NCT01976143 - 10 patients NCT01991678 - 12 patients |
| Arm/Group Title | 145 mg/m2 | 120 mg/m2 | 95 mg/m2 | 50 mg/m2 |
|---|---|---|---|---|
| Arm/Group Description | NKTR-102: A 90 minute IV infusion of 145 mg/m2 | NKTR-102: A 90 minute IV infusion of 120 mg/m2 | NKTR-102: A 90 minute IV infusion of 95 mg/m2 | NKTR-102: A 90 minute IV infusion of 50 mg/m2 |
| Period Title: Overall Study | ||||
| STARTED | 20 | 4 | 1 | 2 |
| COMPLETED | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 20 | 4 | 1 | 2 |
Baseline Characteristics
| Arm/Group Title | 145 mg/m2 | 120 mg/m2 | 95 mg/m2 | 50 mg/m2 | Total |
|---|---|---|---|---|---|
| Arm/Group Description | NKTR-102: A 90 minute IV infusion of 145 mg/m2 | NKTR-102: A 90 minute IV infusion of 120 mg/m2 | NKTR-102: A 90 minute IV infusion of 95 mg/m2 | NKTR-102: A 90 minute IV infusion of 50 mg/m2 | Total of all reporting groups |
| Overall Participants | 20 | 4 | 1 | 2 | 27 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
55.4
(9.92)
|
63.0
(9.98)
|
44.0
(NA)
|
53.5
(3.54)
|
56.0
(10.01)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
13
65%
|
2
50%
|
1
100%
|
1
50%
|
17
63%
|
| Male |
7
35%
|
2
50%
|
0
0%
|
1
50%
|
10
37%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
2
10%
|
1
25%
|
0
0%
|
2
100%
|
5
18.5%
|
| Not Hispanic or Latino |
17
85%
|
3
75%
|
1
100%
|
0
0%
|
21
77.8%
|
| Unknown or Not Reported |
1
5%
|
0
0%
|
0
0%
|
0
0%
|
1
3.7%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
3
15%
|
0
0%
|
1
100%
|
0
0%
|
4
14.8%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
1
5%
|
0
0%
|
0
0%
|
0
0%
|
1
3.7%
|
| White |
14
70%
|
4
100%
|
0
0%
|
2
100%
|
20
74.1%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
2
10%
|
0
0%
|
0
0%
|
0
0%
|
2
7.4%
|
| Primary Tumor Diagnosis (Count of Participants) | |||||
| Breast |
3
15%
|
0
0%
|
1
100%
|
0
0%
|
4
14.8%
|
| Colorectal |
8
40%
|
2
50%
|
0
0%
|
0
0%
|
10
37%
|
| Liver |
0
0%
|
1
25%
|
0
0%
|
2
100%
|
3
11.1%
|
| Lung |
1
5%
|
0
0%
|
0
0%
|
0
0%
|
1
3.7%
|
| Other |
5
25%
|
0
0%
|
0
0%
|
0
0%
|
5
18.5%
|
| Ovary |
1
5%
|
1
25%
|
0
0%
|
0
0%
|
2
7.4%
|
| Pancreas |
2
10%
|
0
0%
|
0
0%
|
0
0%
|
2
7.4%
|
| Stage at Original NKTR-102 Study Enrollment (Count of Participants) | |||||
| I |
2
10%
|
1
25%
|
0
0%
|
2
100%
|
5
18.5%
|
| II |
3
15%
|
1
25%
|
0
0%
|
0
0%
|
4
14.8%
|
| IIA |
0
0%
|
0
0%
|
1
100%
|
0
0%
|
1
3.7%
|
| III |
4
20%
|
1
25%
|
0
0%
|
0
0%
|
5
18.5%
|
| IV |
7
35%
|
0
0%
|
0
0%
|
0
0%
|
7
25.9%
|
| Unknown |
4
20%
|
1
25%
|
0
0%
|
0
0%
|
5
18.5%
|
| Time Since Initial Diagnosis to Original NKTR-102 Study (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
5.936
(5.3536)
|
5.040
(1.2142)
|
15.780
(NA)
|
3.450
(0.0707)
|
5.984
(5.0437)
|
| Treatment Duration in Original NKTR-102 Study (days) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [days] |
56.6
(125.67)
|
141.5
(179.04)
|
1008.0
(NA)
|
21.0
(0.00)
|
101.7
(221.68)
|
| Time Since Metastatic Diagnosis to Original NKTR-102 Study (days) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [days] |
3.666
(2.3677)
|
2.733
(1.3546)
|
3.660
(NA)
|
0.000
(NA)
|
3.357
(2.2403)
|
Outcome Measures
| Title | Length of Exposure to NKTR-102 |
|---|---|
| Description | To provide access to NKTR-102 to subjects who previously received NKTR-102 in a clinical trial and were without signs of disease progression since receiving NKTR-102. |
| Time Frame | Screening, Every 21 day cycle of treatment and Quarterly Follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 145 mg/m2 | 120 mg/m2 | 95 mg/m2 | 50 mg/m2 |
|---|---|---|---|---|
| Arm/Group Description | NKTR-102: A 90 minute IV infusion of 145 mg/m2 | NKTR-102: A 90 minute IV infusion of 120 mg/m2 | NKTR-102: A 90 minute IV infusion of 95 mg/m2 | NKTR-102: A 90 minute IV infusion of 50 mg/m2 |
| Measure Participants | 20 | 4 | 1 | 2 |
| Mean (Standard Deviation) [days] |
139.0
(126.19)
|
33.0
(14.07)
|
126.0
(NA)
|
21.0
(0.00)
|
| Title | Adverse Events |
|---|---|
| Description | To evaluate the safety of continued exposure to NKTR-102. |
| Time Frame | Screening, Every 21 day cycle of treatment and Quarterly Follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 145 mg/m2 | 120 mg/m2 | 95 mg/m2 | 50 mg/m2 |
|---|---|---|---|---|
| Arm/Group Description | NKTR-102: A 90 minute IV infusion of 145 mg/m2 | NKTR-102: A 90 minute IV infusion of 120 mg/m2 | NKTR-102: A 90 minute IV infusion of 95 mg/m2 | NKTR-102: A 90 minute IV infusion of 50 mg/m2 |
| Measure Participants | 20 | 4 | 1 | 2 |
| # of Subjects with Anemia |
3
|
1
|
0
|
0
|
| # of Subjects with Neutropenia |
3
|
0
|
0
|
0
|
| # of Subjects with Leukopenia |
1
|
0
|
0
|
0
|
| # of Subjects with Tachycardia |
1
|
0
|
0
|
0
|
| # of Subjects with Vision Blurred |
3
|
1
|
0
|
0
|
| # of Subjects with Photophobia |
1
|
0
|
0
|
0
|
| # of Subjects with Diarrhea |
11
|
3
|
0
|
0
|
| # of Subjects with Nausea |
6
|
0
|
0
|
0
|
| # of Subjects with Vomiting |
4
|
2
|
0
|
0
|
| # of Subjects with Constipation |
4
|
1
|
0
|
0
|
| # of Subjects with Abdominal Pain |
2
|
1
|
0
|
1
|
| # of Subjects with Dyspepsia |
2
|
0
|
0
|
0
|
| # of Subjects with Upper Abdominal Pain |
1
|
0
|
0
|
0
|
| # of Subjects with Ascites |
0
|
0
|
0
|
1
|
| # of Subjects with Dry Mouth |
0
|
1
|
0
|
0
|
| # of Subjects with Hypoaesthesia Oral |
1
|
0
|
0
|
0
|
| # of Subjects with Mouth Ulceration |
1
|
0
|
0
|
0
|
| # of Subjects with Stomatitis |
1
|
0
|
0
|
0
|
| # of Subjects with Fatigue |
6
|
1
|
0
|
1
|
| # of Subjects with Oedema Peripheral |
2
|
0
|
0
|
0
|
| # of Subjects with Non-Cardiac Chest Pain |
1
|
0
|
0
|
0
|
| # of Subjects with Pyrexia |
1
|
0
|
0
|
0
|
| # of Subjects with Urinary Tract Infections |
3
|
0
|
0
|
0
|
| # of Subjects with Gastroenteritis |
1
|
1
|
0
|
0
|
| # of Subjects with Influenza |
0
|
1
|
1
|
0
|
| # of Subjects with Abdominal Infection |
0
|
1
|
0
|
0
|
| # of Subjects with Gingival Infection |
1
|
0
|
0
|
0
|
| # of Subjects with Herpex Simplex Encephalitis |
0
|
0
|
0
|
1
|
| # of Subjects with Weight Decreased |
5
|
0
|
0
|
0
|
| # of Subjects with Neutrophil Count Decreased |
1
|
1
|
1
|
0
|
| # of Subjects with Aspartate Aminostransferase |
1
|
1
|
0
|
0
|
| # of Subjects with White blood cell count decreased |
1
|
1
|
0
|
0
|
| # of Subjects with Activated partial thromboplastin time prolonged |
0
|
1
|
0
|
0
|
| # of Subjects with Alanine Aminotransferase Increased |
1
|
0
|
0
|
0
|
| # of Subjects with Blood bilirubin increased |
1
|
0
|
0
|
0
|
| # of Subjects with Blood creatine increased |
1
|
0
|
0
|
0
|
| # of Subjects with Liver Function Test abnormal |
1
|
0
|
0
|
0
|
| # of Subjects with Prothrombin time prolonged |
1
|
0
|
0
|
0
|
| # of Subjects with decreased appetite |
4
|
0
|
1
|
1
|
| # of Subjects with hypoalbuminemia |
3
|
1
|
0
|
0
|
| # of Subjects with hypokalemia |
2
|
1
|
0
|
0
|
| # of Subjects with hypoglycemia |
1
|
1
|
0
|
0
|
| # of Subjects with hyponatremia |
2
|
0
|
0
|
0
|
| # of Subjects with dehydration |
0
|
1
|
0
|
0
|
| # of Subjects with Hyperglycemia |
1
|
0
|
0
|
0
|
| # of Subjects with Hypocalcemia |
1
|
0
|
0
|
0
|
| # of Subjects with Hypomagnesemia |
1
|
0
|
0
|
0
|
| # of Subjects with Hypophosphatemia |
1
|
0
|
0
|
0
|
| # of Subjects with Back Pain |
1
|
0
|
0
|
0
|
| # of Subjects with Flank Pain |
1
|
0
|
0
|
0
|
| # of Subjects with Muscular Weakness |
0
|
1
|
0
|
0
|
| # of Subjects with Musculoskeletal Pain |
0
|
1
|
0
|
0
|
| # of Subjects with Appendix Cancer |
1
|
0
|
0
|
0
|
| # of Subjects with Cancer Pain |
1
|
0
|
0
|
0
|
| # of Subjects with Aphonia |
1
|
0
|
0
|
0
|
| # of Subjects with Dyasgeusia |
1
|
0
|
0
|
0
|
| # of Subjects with Hypoaesthsia |
1
|
0
|
0
|
0
|
| # of Subjects with Depressed Mood |
1
|
0
|
0
|
0
|
| # of Subjects with Insomnia |
0
|
0
|
0
|
1
|
| # of Subjects with Proteinuria |
1
|
0
|
0
|
0
|
| # of Subjects with Renal Failure Acute |
1
|
0
|
0
|
0
|
| # of Subjects with Vaginal Hemorrhage |
1
|
0
|
0
|
0
|
| # of Subjects with Oropharyngeal Pain |
2
|
1
|
0
|
0
|
| # of Subjects with Cough |
1
|
0
|
0
|
0
|
| # of Subjects with Dsypnoea |
1
|
0
|
0
|
0
|
| # of Subjects with Epistaxis |
1
|
0
|
0
|
0
|
| # of Subjects with Hypoxis |
1
|
0
|
0
|
0
|
| # of Subjects with Pneumothorax |
1
|
0
|
0
|
0
|
| # of Subjects with Productive Cough |
1
|
0
|
0
|
0
|
| # of Subjects with Pulmonary Embolism |
1
|
0
|
0
|
0
|
| # of Subjects with Decubitus Ulcer |
2
|
0
|
0
|
0
|
| # of Subjects with Pruritus |
1
|
0
|
0
|
1
|
| # of Subjects with Rash |
2
|
0
|
0
|
0
|
| # of Subjects with Alopecia |
1
|
0
|
0
|
0
|
| # of Subjects with Hypotension |
1
|
0
|
0
|
0
|
| # of Subjects with Pelvic Venous Thrombosis |
1
|
0
|
0
|
0
|
| Number of Subjects with at least one TEAE |
20
|
4
|
1
|
2
|
| # of Subjects with Peritonitis Bacterial |
0
|
1
|
0
|
0
|
| Title | Disease Status |
|---|---|
| Description | To observe disease status and survival status in subjects receiving NKTR-102. |
| Time Frame | Screening, Every 21 day cycle of treatment and Quarterly Follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Four participants including the one in Group 4 had to discontinue treatment prior to measuring this outcome |
| Arm/Group Title | 145 mg/m2 | 120 mg/m2 | 95 mg/m2 | 50 mg/m2 |
|---|---|---|---|---|
| Arm/Group Description | NKTR-102: A 90 minute IV infusion of 145 mg/m2 | NKTR-102: A 90 minute IV infusion of 120 mg/m2 | NKTR-102: A 90 minute IV infusion of 95 mg/m2 | NKTR-102: A 90 minute IV infusion of 50 mg/m2 |
| Measure Participants | 18 | 4 | 1 | 0 |
| Stable Disease (SD) |
10
50%
|
1
25%
|
0
0%
|
0
0%
|
| Progressive Disease (PD) |
8
40%
|
3
75%
|
1
100%
|
0
0%
|
| Title | Efficacy of NKTR-102 |
|---|---|
| Description | To evaluate the efficacy of NKTR-102 in subjects with advanced or metastatic solid tumors. |
| Time Frame | Screening, Every 21 day cycle of treatment and Quarterly Follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Four participants including the one in Group 4 had to discontinue treatment prior to this outcome being measured. |
| Arm/Group Title | 145 mg/m2 | 120 mg/m2 | 95 mg/m2 | 50 mg/m2 |
|---|---|---|---|---|
| Arm/Group Description | NKTR-102: A 90 minute IV infusion of 145 mg/m2 | NKTR-102: A 90 minute IV infusion of 120 mg/m2 | NKTR-102: A 90 minute IV infusion of 95 mg/m2 | NKTR-102: A 90 minute IV infusion of 50 mg/m2 |
| Measure Participants | 18 | 4 | 1 | 0 |
| # of Participants who achieved Complete Response (CR) |
0
0%
|
0
0%
|
0
0%
|
|
| # of Participants who achieved Partial Response (PR) |
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | Adverse event data was collected over the course of the study approximately 6 years | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | 145 mg/m2 | 120 mg/m2 | 95 mg/m2 | 50 mg/m2 | ||||
| Arm/Group Description | NKTR-102: A 90 minute IV infusion of 145 mg/m2 | NKTR-102: A 90 minute IV infusion of 120 mg/m2 | NKTR-102: A 90 minute IV infusion of 95 mg/m2 | NKTR-102: A 90 minute IV infusion of 50 mg/m2 | ||||
All Cause Mortality |
||||||||
| 145 mg/m2 | 120 mg/m2 | 95 mg/m2 | 50 mg/m2 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 16/20 (80%) | 3/4 (75%) | 0/1 (0%) | 0/2 (0%) | ||||
Serious Adverse Events |
||||||||
| 145 mg/m2 | 120 mg/m2 | 95 mg/m2 | 50 mg/m2 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/20 (25%) | 1/4 (25%) | 0/1 (0%) | 1/2 (50%) | ||||
| Gastrointestinal disorders | ||||||||
| Diarrhea | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| General disorders | ||||||||
| Infections and infestations | ||||||||
| Abdominal Infection | 0/20 (0%) | 1/4 (25%) | 0/1 (0%) | 0/2 (0%) | ||||
| Gastroenteritis | 0/20 (0%) | 1/4 (25%) | 0/1 (0%) | 0/2 (0%) | ||||
| Herpex simplex encephalitis | 0/20 (0%) | 0/4 (0%) | 0/1 (0%) | 1/2 (50%) | ||||
| Peritonitis bacterial | 0/20 (0%) | 1/4 (25%) | 0/1 (0%) | 0/2 (0%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Appendix Cancer | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| Cancer Pain | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| Renal and urinary disorders | ||||||||
| Renal Failure Acute | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Dyspnoea | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| Pneumothorax | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| Pulmonary Embolism | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| Vascular disorders | ||||||||
| Hypotension | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| 145 mg/m2 | 120 mg/m2 | 95 mg/m2 | 50 mg/m2 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 20/20 (100%) | 4/4 (100%) | 1/1 (100%) | 2/2 (100%) | ||||
| Blood and lymphatic system disorders | ||||||||
| # of subjects with Leukopenia | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| Cardiac disorders | ||||||||
| # of subjects with Anemia | 3/20 (15%) | 1/4 (25%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Tachycardia | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Oedema Peripheral | 2/20 (10%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Hypotension | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| Eye disorders | ||||||||
| # of subjects with Vision Blurred | 3/20 (15%) | 1/4 (25%) | 0/1 (0%) | 0/2 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| # of subjects with Diarrhea | 11/20 (55%) | 3/4 (75%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Nausea | 6/20 (30%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Vomiting | 4/20 (20%) | 2/4 (50%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Constipation | 4/20 (20%) | 1/4 (25%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Dyspepsia | 2/20 (10%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| General disorders | ||||||||
| # of subjects with Photophobia | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Abdominal Pain | 2/20 (10%) | 1/4 (25%) | 0/1 (0%) | 1/2 (50%) | ||||
| # of subjects with Upper Abdominal Pain | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Dry Mouth | 0/20 (0%) | 1/4 (25%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Fatigue | 6/20 (30%) | 1/4 (25%) | 0/1 (0%) | 1/2 (50%) | ||||
| # of subjects with Non-Cardiac Chest Pain | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Pyrexia | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Weight Decreased | 5/20 (25%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Decreased Appetite | 4/20 (20%) | 0/4 (0%) | 1/1 (100%) | 1/2 (50%) | ||||
| # of subjects with Appendix Pain | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Cancer Pain | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Aphonia | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Dysgeusia | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Hypoesthesia | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Oropharyngeal Pain | 2/20 (10%) | 1/4 (25%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Alopecia | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| Hepatobiliary disorders | ||||||||
| # of subjects with Ascites | 0/20 (0%) | 0/4 (0%) | 0/1 (0%) | 1/2 (50%) | ||||
| Immune system disorders | ||||||||
| # of subjects with Neutropenia | 3/20 (15%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Neutrophil Count Decreased | 1/20 (5%) | 1/4 (25%) | 1/1 (100%) | 0/2 (0%) | ||||
| # of subjects with White Blood Cell count decreased | 1/20 (5%) | 1/4 (25%) | 0/1 (0%) | 0/2 (0%) | ||||
| Infections and infestations | ||||||||
| # of subjects with Mouth Ulceration | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Stomatitis | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Urinary Tract Infections | 3/20 (15%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Gastroenteritis | 1/20 (5%) | 1/4 (25%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Influenza | 0/20 (0%) | 1/4 (25%) | 1/1 (100%) | 0/2 (0%) | ||||
| # of subjects with Abdominal Infection | 0/20 (0%) | 1/4 (25%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Gingival Infection | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Herpes Simplex Encephalitis | 0/20 (0%) | 0/4 (0%) | 0/1 (0%) | 1/2 (50%) | ||||
| # of subjects with Decubitus Ulcer | 2/20 (10%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Peritonitis Bacterial | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| Metabolism and nutrition disorders | ||||||||
| # of subjects with Aspartate Aminotransferase Increased | 1/20 (5%) | 1/4 (25%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Activated Partial Thromboplastin Time Prolonged | 0/20 (0%) | 1/4 (25%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Alanine Aminotransferase Increased | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Blood Bilirubin Increased | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Liver Function Test Abnormal | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Prothrombin Time Prolonged | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Hypoalbuminemia | 3/20 (15%) | 1/4 (25%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Hypokalemia | 2/20 (10%) | 1/4 (25%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Hypoglycemia | 1/20 (5%) | 1/4 (25%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Hyponatremia | 2/20 (10%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Dehydration | 0/20 (0%) | 1/4 (25%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Hyperglycemia | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Hypocalcemia | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Hypomagenesemia | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Hypophosphatemia | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Blood Creatine Increased | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| # of subjects with Back Pain | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Flank Pain | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Muscular Weakness | 0/20 (0%) | 1/4 (25%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Musculoskeletal Pain | 0/20 (0%) | 1/4 (25%) | 0/1 (0%) | 0/2 (0%) | ||||
| Nervous system disorders | ||||||||
| # of subjects with Hypoesthesia Oral | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| Psychiatric disorders | ||||||||
| # of subjects with Depressed Mood | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Insomnia | 0/20 (0%) | 0/4 (0%) | 0/1 (0%) | 1/2 (50%) | ||||
| Renal and urinary disorders | ||||||||
| # of subjects with Proteinuria | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Acute Renal Failure | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| Reproductive system and breast disorders | ||||||||
| # of subjects with Vaginal Hemorrhage | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| # of subjects with Cough | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Dyspnea | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Epistaxis | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Hypoxia | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Pneumothorax | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Productive Cough | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| # of subjects with Pruritus | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 1/2 (50%) | ||||
| # of subjects with Rash | 2/20 (10%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| Vascular disorders | ||||||||
| # of subjects with Pulmonary Embolism | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (0%) | ||||
| # of subjects with Pelvic Venous Thrombosis | 1/20 (5%) | 0/4 (0%) | 0/1 (0%) | 0/2 (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:
NCT01457118
Other Study ID Numbers:
- 11-PIR-09
First Posted:
Oct 21, 2011
Last Update Posted:
Jul 12, 2021
Last Verified:
Jul 1, 2021