Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Breast Cancer

Nektar Therapeutics

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Tumor

Treatments: Drug: NKTR-102

Study type: Interventional

Funder types: Industry

Identifiers

NCT00802945

08-PIR-05

Details and patient eligibility

About

This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients with metastatic or locally advanced breast cancer whose disease has failed prior taxane-based treatment in the metastatic setting.

Patients will be randomized 1:1 into one of two treatment arms. NKTR 102 will be administered at a dose level of 145 mg/m2 in both arms. In Arm A, NKTR-102 will be given on a q14d schedule. In Arm B, NKTR-102 will be given on a q21d schedule. Approximately 70 patients may be evaluated in this study with approximately 35 patients enrolled in each treatment arm.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Inoperable metastatic or locally advanced breast cancer
2. No more than 2 prior chemotherapy regimens given in a metastatic or locally advanced setting and prior treatment in the metastatic setting must have included a taxane

Exclusion criteria

1. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to Day 1 of Cycle 1
2. Patients who have had any major surgery within 4 weeks prior to Day 1 of Cycle or minor surgery within 2 weeks prior to Day 1 of Cycle 1

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

70 participants in 2 patient groups

NKTR-102 q14d

Experimental group

Description:

NKTR-102

Treatment:

Drug: NKTR-102

Drug: NKTR-102

NKTR-102 q21d

Experimental group

Description:

NKTR-102

Treatment:

Drug: NKTR-102

Drug: NKTR-102