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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01457118
Other study ID # 11-PIR-09
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2011
Est. completion date November 2017

Study information

Verified date July 2021
Source Nektar Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date November 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion: 1. Received prior treatment with NKTR-102 2. Free of disease progression since receiving NKTR-102 3. Adequate bone marrow and organ function 4. Treatment with NKTR-102 in the extension study to begin within 8 weeks after receipt of their of last dose of NKTR-102 5. Agree to use adequate contraception Exclusion: 1. 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 2. 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 3. Pregnancy or lactation

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.
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.

Locations

Country Name City State
Belgium Investigator Site - Bruxelles Bruxelles
Belgium Investigator Site - Liege Liege
United States Investigator Site - Cleveland Cleveland Ohio
United States Investigator Site - Los Angeles Los Angeles California
United States Investigator Site - Minneapolis Minneapolis Minnesota
United States Investigator Site - San Francisco San Francisco California
United States Investigator Site - Whittier Whittier California

Sponsors (1)

Lead Sponsor Collaborator
Nektar Therapeutics

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Length of Exposure to NKTR-102 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. Screening, Every 21 day cycle of treatment and Quarterly Follow-up
Secondary Adverse Events To evaluate the safety of continued exposure to NKTR-102. Screening, Every 21 day cycle of treatment and Quarterly Follow-up
Secondary Disease Status To observe disease status and survival status in subjects receiving NKTR-102. Screening, Every 21 day cycle of treatment and Quarterly Follow-up
Secondary Efficacy of NKTR-102 To evaluate the efficacy of NKTR-102 in subjects with advanced or metastatic solid tumors. Screening, Every 21 day cycle of treatment and Quarterly Follow-up
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