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

Nektar Therapeutics

Status and phase: Completed; Phase 2

Conditions: Malignant Solid Tumor

Treatments: Drug: NKTR-102 145 mg/m2; Drug: NKTR-102 50 mg/m2; Drug: NKTR-102 95 mg/m2; Drug: NKTR-102 120 mg/m2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01457118

11-PIR-09

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

NKTR-102

Experimental group

Treatment:

Drug: NKTR-102 95 mg/m2

Drug: NKTR-102 120 mg/m2

Drug: NKTR-102 145 mg/m2

Drug: NKTR-102 50 mg/m2