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

Nektar Therapeutics27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malignant Solid Tumor

Interventions

NKTR-102 145 mg/m2DRUG

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/m2DRUG

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/m2DRUG

A 90 minute IV infusion of 95 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

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

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Adverse Events

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

Time frame: 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.

Time frame: 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.

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

Data from ClinicalTrials.gov

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