An Extension Study of NKTR-102 in Cancer Patients Previously Enrolled in NKTR-102 Studies
NCT ID: NCT01457118
Last Updated: 2021-07-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
27 participants
INTERVENTIONAL
2011-10-31
2017-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NKTR-102
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Nektar Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Nektar Therapeutics
Locations
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Investigator Site - Los Angeles
Los Angeles, California, United States
Investigator Site - San Francisco
San Francisco, California, United States
Investigator Site - Whittier
Whittier, California, United States
Investigator Site - Minneapolis
Minneapolis, Minnesota, United States
Investigator Site - Cleveland
Cleveland, Ohio, United States
Investigator Site - Bruxelles
Brussels, , Belgium
Investigator Site - Liege
Liège, , Belgium
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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11-PIR-09
Identifier Type: -
Identifier Source: org_study_id
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