Trial Outcomes & Findings for An Extension Study of NKTR-102 in Cancer Patients Previously Enrolled in NKTR-102 Studies (NCT NCT01457118)

Last Updated: 2021-07-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

Screening, Every 21 day cycle of treatment and Quarterly Follow-up

Results posted on

2021-07-12

Participant Flow

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

Participant milestones

Participant milestones
Measure	145 mg/m2 NKTR-102: A 90 minute IV infusion of 145 mg/m2	120 mg/m2 NKTR-102: A 90 minute IV infusion of 120 mg/m2	95 mg/m2 NKTR-102: A 90 minute IV infusion of 95 mg/m2	50 mg/m2 NKTR-102: A 90 minute IV infusion of 50 mg/m2
Overall Study STARTED	20	4	1	2
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	20	4	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	145 mg/m2 NKTR-102: A 90 minute IV infusion of 145 mg/m2	120 mg/m2 NKTR-102: A 90 minute IV infusion of 120 mg/m2	95 mg/m2 NKTR-102: A 90 minute IV infusion of 95 mg/m2	50 mg/m2 NKTR-102: A 90 minute IV infusion of 50 mg/m2
Overall Study Adverse Event	1	0	0	1
Overall Study Clinical Progression	0	1	0	1
Overall Study Physician Decision	2	0	0	0
Overall Study Progressive Disease by RECIST	12	3	1	0
Overall Study Withdrawal by Subject	5	0	0	0

Baseline Characteristics

The number analyzed differs from overall as not all patients reached metastatic diagnosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	145 mg/m2 n=20 Participants NKTR-102: A 90 minute IV infusion of 145 mg/m2	120 mg/m2 n=4 Participants NKTR-102: A 90 minute IV infusion of 120 mg/m2	95 mg/m2 n=1 Participants NKTR-102: A 90 minute IV infusion of 95 mg/m2	50 mg/m2 n=2 Participants NKTR-102: A 90 minute IV infusion of 50 mg/m2	Total n=27 Participants Total of all reporting groups
Age, Continuous	55.4 years STANDARD_DEVIATION 9.92 • n=20 Participants	63.0 years STANDARD_DEVIATION 9.98 • n=4 Participants	44.0 years STANDARD_DEVIATION NA • n=1 Participants	53.5 years STANDARD_DEVIATION 3.54 • n=2 Participants	56.0 years STANDARD_DEVIATION 10.01 • n=27 Participants
Sex: Female, Male Female	13 Participants n=20 Participants	2 Participants n=4 Participants	1 Participants n=1 Participants	1 Participants n=2 Participants	17 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=20 Participants	2 Participants n=4 Participants	0 Participants n=1 Participants	1 Participants n=2 Participants	10 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=20 Participants	1 Participants n=4 Participants	0 Participants n=1 Participants	2 Participants n=2 Participants	5 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=20 Participants	3 Participants n=4 Participants	1 Participants n=1 Participants	0 Participants n=2 Participants	21 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=20 Participants	0 Participants n=4 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	1 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=4 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	3 Participants n=20 Participants	0 Participants n=4 Participants	1 Participants n=1 Participants	0 Participants n=2 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=4 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=20 Participants	0 Participants n=4 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	1 Participants n=27 Participants
Race (NIH/OMB) White	14 Participants n=20 Participants	4 Participants n=4 Participants	0 Participants n=1 Participants	2 Participants n=2 Participants	20 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants	0 Participants n=4 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=20 Participants	0 Participants n=4 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	2 Participants n=27 Participants
Primary Tumor Diagnosis Breast	3 Participants n=20 Participants	0 Participants n=4 Participants	1 Participants n=1 Participants	0 Participants n=2 Participants	4 Participants n=27 Participants
Primary Tumor Diagnosis Colorectal	8 Participants n=20 Participants	2 Participants n=4 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	10 Participants n=27 Participants
Primary Tumor Diagnosis Liver	0 Participants n=20 Participants	1 Participants n=4 Participants	0 Participants n=1 Participants	2 Participants n=2 Participants	3 Participants n=27 Participants
Primary Tumor Diagnosis Lung	1 Participants n=20 Participants	0 Participants n=4 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	1 Participants n=27 Participants
Primary Tumor Diagnosis Other	5 Participants n=20 Participants	0 Participants n=4 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	5 Participants n=27 Participants
Primary Tumor Diagnosis Ovary	1 Participants n=20 Participants	1 Participants n=4 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	2 Participants n=27 Participants
Primary Tumor Diagnosis Pancreas	2 Participants n=20 Participants	0 Participants n=4 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	2 Participants n=27 Participants
Stage at Original NKTR-102 Study Enrollment I	2 Participants n=20 Participants	1 Participants n=4 Participants	0 Participants n=1 Participants	2 Participants n=2 Participants	5 Participants n=27 Participants
Stage at Original NKTR-102 Study Enrollment II	3 Participants n=20 Participants	1 Participants n=4 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	4 Participants n=27 Participants
Stage at Original NKTR-102 Study Enrollment IIA	0 Participants n=20 Participants	0 Participants n=4 Participants	1 Participants n=1 Participants	0 Participants n=2 Participants	1 Participants n=27 Participants
Stage at Original NKTR-102 Study Enrollment III	4 Participants n=20 Participants	1 Participants n=4 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	5 Participants n=27 Participants
Stage at Original NKTR-102 Study Enrollment IV	7 Participants n=20 Participants	0 Participants n=4 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	7 Participants n=27 Participants
Stage at Original NKTR-102 Study Enrollment Unknown	4 Participants n=20 Participants	1 Participants n=4 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	5 Participants n=27 Participants
Time Since Initial Diagnosis to Original NKTR-102 Study	5.936 years STANDARD_DEVIATION 5.3536 • n=20 Participants	5.040 years STANDARD_DEVIATION 1.2142 • n=4 Participants	15.780 years STANDARD_DEVIATION NA • n=1 Participants	3.450 years STANDARD_DEVIATION 0.0707 • n=2 Participants	5.984 years STANDARD_DEVIATION 5.0437 • n=27 Participants
Treatment Duration in Original NKTR-102 Study	56.6 days STANDARD_DEVIATION 125.67 • n=20 Participants	141.5 days STANDARD_DEVIATION 179.04 • n=4 Participants	1008.0 days STANDARD_DEVIATION NA • n=1 Participants	21.0 days STANDARD_DEVIATION 0.00 • n=2 Participants	101.7 days STANDARD_DEVIATION 221.68 • n=27 Participants
Time Since Metastatic Diagnosis to Original NKTR-102 Study	3.666 days STANDARD_DEVIATION 2.3677 • n=18 Participants • The number analyzed differs from overall as not all patients reached metastatic diagnosis	2.733 days STANDARD_DEVIATION 1.3546 • n=4 Participants • The number analyzed differs from overall as not all patients reached metastatic diagnosis	3.660 days STANDARD_DEVIATION NA • n=1 Participants • The number analyzed differs from overall as not all patients reached metastatic diagnosis	0.000 days STANDARD_DEVIATION NA • n=1 Participants • The number analyzed differs from overall as not all patients reached metastatic diagnosis	3.357 days STANDARD_DEVIATION 2.2403 • n=24 Participants • The number analyzed differs from overall as not all patients reached metastatic diagnosis

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	145 mg/m2 n=20 Participants NKTR-102: A 90 minute IV infusion of 145 mg/m2	120 mg/m2 n=4 Participants NKTR-102: A 90 minute IV infusion of 120 mg/m2	95 mg/m2 n=1 Participants NKTR-102: A 90 minute IV infusion of 95 mg/m2	50 mg/m2 n=2 Participants NKTR-102: A 90 minute IV infusion of 50 mg/m2
Length of Exposure to NKTR-102	139.0 days Standard Deviation 126.19	33.0 days Standard Deviation 14.07	126.0 days Standard Deviation NA There is only one participant	21.0 days Standard Deviation 0.00

SECONDARY outcome

Timeframe: Screening, Every 21 day cycle of treatment and Quarterly Follow-up

To evaluate the safety of continued exposure to NKTR-102.

Outcome measures

Outcome measures
Measure	145 mg/m2 n=20 Participants NKTR-102: A 90 minute IV infusion of 145 mg/m2	120 mg/m2 n=4 Participants NKTR-102: A 90 minute IV infusion of 120 mg/m2	95 mg/m2 n=1 Participants NKTR-102: A 90 minute IV infusion of 95 mg/m2	50 mg/m2 n=2 Participants NKTR-102: A 90 minute IV infusion of 50 mg/m2
Adverse Events # of Subjects with hypoglycemia	1 # of events	1 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with hyponatremia	2 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Appendix Cancer	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Cancer Pain	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Anemia	3 # of events	1 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Neutropenia	3 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Leukopenia	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Tachycardia	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Vision Blurred	3 # of events	1 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Photophobia	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Diarrhea	11 # of events	3 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Nausea	6 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Vomiting	4 # of events	2 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Constipation	4 # of events	1 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Abdominal Pain	2 # of events	1 # of events	0 # of events	1 # of events
Adverse Events # of Subjects with Dyspepsia	2 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Upper Abdominal Pain	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Ascites	0 # of events	0 # of events	0 # of events	1 # of events
Adverse Events # of Subjects with Dry Mouth	0 # of events	1 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Hypoaesthesia Oral	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Mouth Ulceration	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Stomatitis	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Fatigue	6 # of events	1 # of events	0 # of events	1 # of events
Adverse Events # of Subjects with Oedema Peripheral	2 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Non-Cardiac Chest Pain	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Pyrexia	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Urinary Tract Infections	3 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Gastroenteritis	1 # of events	1 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Influenza	0 # of events	1 # of events	1 # of events	0 # of events
Adverse Events # of Subjects with Abdominal Infection	0 # of events	1 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Gingival Infection	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Herpex Simplex Encephalitis	0 # of events	0 # of events	0 # of events	1 # of events
Adverse Events # of Subjects with Weight Decreased	5 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Neutrophil Count Decreased	1 # of events	1 # of events	1 # of events	0 # of events
Adverse Events # of Subjects with Aspartate Aminostransferase	1 # of events	1 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with White blood cell count decreased	1 # of events	1 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Activated partial thromboplastin time prolonged	0 # of events	1 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Alanine Aminotransferase Increased	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Blood bilirubin increased	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Blood creatine increased	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Liver Function Test abnormal	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Prothrombin time prolonged	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with decreased appetite	4 # of events	0 # of events	1 # of events	1 # of events
Adverse Events # of Subjects with hypoalbuminemia	3 # of events	1 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with hypokalemia	2 # of events	1 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with dehydration	0 # of events	1 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Hyperglycemia	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Hypocalcemia	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Hypomagnesemia	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Hypophosphatemia	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Back Pain	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Flank Pain	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Muscular Weakness	0 # of events	1 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Musculoskeletal Pain	0 # of events	1 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Aphonia	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Dyasgeusia	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Hypoaesthsia	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Depressed Mood	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Insomnia	0 # of events	0 # of events	0 # of events	1 # of events
Adverse Events # of Subjects with Proteinuria	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Renal Failure Acute	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Vaginal Hemorrhage	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Oropharyngeal Pain	2 # of events	1 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Cough	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Dsypnoea	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Epistaxis	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Hypoxis	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Pneumothorax	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Productive Cough	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Pulmonary Embolism	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Decubitus Ulcer	2 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Pruritus	1 # of events	0 # of events	0 # of events	1 # of events
Adverse Events # of Subjects with Rash	2 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Alopecia	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Hypotension	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events # of Subjects with Pelvic Venous Thrombosis	1 # of events	0 # of events	0 # of events	0 # of events
Adverse Events Number of Subjects with at least one TEAE	20 # of events	4 # of events	1 # of events	2 # of events
Adverse Events # of Subjects with Peritonitis Bacterial	0 # of events	1 # of events	0 # of events	0 # of events

SECONDARY outcome

Timeframe: Screening, Every 21 day cycle of treatment and Quarterly Follow-up

Population: Four participants including the one in Group 4 had to discontinue treatment prior to measuring this outcome

To observe disease status and survival status in subjects receiving NKTR-102.

Outcome measures

Outcome measures
Measure	145 mg/m2 n=18 Participants NKTR-102: A 90 minute IV infusion of 145 mg/m2	120 mg/m2 n=4 Participants NKTR-102: A 90 minute IV infusion of 120 mg/m2	95 mg/m2 n=1 Participants NKTR-102: A 90 minute IV infusion of 95 mg/m2	50 mg/m2 NKTR-102: A 90 minute IV infusion of 50 mg/m2
Disease Status Stable Disease (SD)	10 Participants	1 Participants	0 Participants	0 Participants
Disease Status Progressive Disease (PD)	8 Participants	3 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Screening, Every 21 day cycle of treatment and Quarterly Follow-up

Population: Four participants including the one in Group 4 had to discontinue treatment prior to this outcome being measured.

To evaluate the efficacy of NKTR-102 in subjects with advanced or metastatic solid tumors.

Outcome measures

Outcome measures
Measure	145 mg/m2 n=18 Participants NKTR-102: A 90 minute IV infusion of 145 mg/m2	120 mg/m2 n=4 Participants NKTR-102: A 90 minute IV infusion of 120 mg/m2	95 mg/m2 n=1 Participants NKTR-102: A 90 minute IV infusion of 95 mg/m2	50 mg/m2 NKTR-102: A 90 minute IV infusion of 50 mg/m2
Efficacy of NKTR-102 # of Participants who achieved Complete Response (CR)	0 participants	0 participants	0 participants	—
Efficacy of NKTR-102 # of Participants who achieved Partial Response (PR)	0 participants	0 participants	0 participants	—

Adverse Events

145 mg/m2

Serious events: 5 serious events

Other events: 20 other events

Deaths: 16 deaths

120 mg/m2

Serious events: 1 serious events

Other events: 4 other events

Deaths: 3 deaths

95 mg/m2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

50 mg/m2

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	145 mg/m2 n=20 participants at risk NKTR-102: A 90 minute IV infusion of 145 mg/m2	120 mg/m2 n=4 participants at risk NKTR-102: A 90 minute IV infusion of 120 mg/m2	95 mg/m2 n=1 participants at risk NKTR-102: A 90 minute IV infusion of 95 mg/m2	50 mg/m2 n=2 participants at risk NKTR-102: A 90 minute IV infusion of 50 mg/m2
Gastrointestinal disorders Diarrhea	5.0% 1/20 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/4 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/1 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/2 • Adverse event data was collected over the course of the study approximately 6 years
Infections and infestations Abdominal Infection	0.00% 0/20 • Adverse event data was collected over the course of the study approximately 6 years	25.0% 1/4 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/1 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/2 • Adverse event data was collected over the course of the study approximately 6 years
Infections and infestations Gastroenteritis	0.00% 0/20 • Adverse event data was collected over the course of the study approximately 6 years	25.0% 1/4 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/1 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/2 • Adverse event data was collected over the course of the study approximately 6 years
Infections and infestations Herpex simplex encephalitis	0.00% 0/20 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/4 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/1 • Adverse event data was collected over the course of the study approximately 6 years	50.0% 1/2 • Adverse event data was collected over the course of the study approximately 6 years
Infections and infestations Peritonitis bacterial	0.00% 0/20 • Adverse event data was collected over the course of the study approximately 6 years	25.0% 1/4 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/1 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/2 • Adverse event data was collected over the course of the study approximately 6 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Appendix Cancer	5.0% 1/20 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/4 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/1 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/2 • Adverse event data was collected over the course of the study approximately 6 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer Pain	5.0% 1/20 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/4 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/1 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/2 • Adverse event data was collected over the course of the study approximately 6 years
Renal and urinary disorders Renal Failure Acute	5.0% 1/20 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/4 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/1 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/2 • Adverse event data was collected over the course of the study approximately 6 years
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.0% 1/20 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/4 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/1 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/2 • Adverse event data was collected over the course of the study approximately 6 years
Respiratory, thoracic and mediastinal disorders Pneumothorax	5.0% 1/20 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/4 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/1 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/2 • Adverse event data was collected over the course of the study approximately 6 years
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	5.0% 1/20 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/4 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/1 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/2 • Adverse event data was collected over the course of the study approximately 6 years
Vascular disorders Hypotension	5.0% 1/20 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/4 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/1 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/2 • Adverse event data was collected over the course of the study approximately 6 years
General disorders Total Number of TESAEs	25.0% 5/20 • Number of events 10 • Adverse event data was collected over the course of the study approximately 6 years	25.0% 1/4 • Number of events 3 • Adverse event data was collected over the course of the study approximately 6 years	0.00% 0/1 • Adverse event data was collected over the course of the study approximately 6 years	50.0% 1/2 • Number of events 1 • Adverse event data was collected over the course of the study approximately 6 years

Other adverse events

Additional Information

Study Director

Nektar Therapeutics

Phone: 415-482-5300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee There are restrictions to the PI's rights to discuss or publish trial results.
Publication restrictions are in place

Restriction type: OTHER