An Extension Study of NKTR-102 in Cancer Patients Previously Enrolled in NKTR-102 Studies

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label, Multicenter, Extension Study of NKTR-102 in Subjects Previously Enrolled in NKTR-102 Studies

Conditions
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Malignant Solid Tumor

Intervention / Treatment
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* Drug: NKTR-102 145 mg/m2
* Drug: NKTR-102 120 mg/m2
* Drug: NKTR-102 95 mg/m2
* Drug: NKTR-102 50 mg/m2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NKTR-102<br> | Drug: NKTR-102 145 mg/m2<br>* A 90 minute IV infusion of 145 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.<br>Drug: NKTR-102 120 mg/m2<br>* A 90 minute IV infusion of 120 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.<br>Drug: NKTR-102 95 mg/m2<br>* A 90 minute IV infusion of 95 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.<br>Drug: NKTR-102 50 mg/m2<br>* A 90 minute IV infusion of 50 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | To evaluate the safety of continued exposure to NKTR-102. | Screening, Every 21 day cycle of treatment and Quarterly Follow-up | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open Label multicenter extension study advanced solid tumors