A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0980 in Combination With Paclitaxel With or Without Bevacizumab in Patients With Locally Recurrent or Metastatic Breast Cancer

Genentech, Inc.0 sites52 target enrollmentDecember 2010

ConditionsBreast Cancer

Interventionsbevacizumab GDC-0980 paclitaxel

Overview

Phase: Phase 1
Intervention: bevacizumab
Conditions: Breast Cancer
Sponsor: Genentech, Inc.
Enrollment: 52
Primary Endpoint: Incidence and nature of dose-limiting toxicities (DLTs)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0980 administered with taxane-based chemotherapy regimens utilized in patients with locally recurrent or metastatic breast cancer.

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

April 2013

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Locally recurrent or metastatic breast cancer, not amenable to resection with curative intent
•For Arm C: Overexpression of HER2
•Eastern Cooperative Oncology Group Performance Status of 0 or 1
•Adequate hematologic and organ function
•Evaluable or measurable disease per RECIST (Response Evaluable Criteria in Solid Tumors)
•Female patients of childbearing potential must use an acceptable method of contraception to prevent pregnancy and to continue its use for the duration of the study

Exclusion Criteria

•Prior anti-cancer therapy of more than two regimens of systemic cytotoxic chemotherapy for advanced or metastatic breast cancer
•Prior anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe of the first dose of study treatment
•History of Type 1 or Type 2 diabetes requiring regular medication
•History of clinically significant cardiac or pulmonary dysfunction
•History of malabsorption syndrome or other condition that would interfere with enteral absorption
•Any condition requiring full-dose anticoagulants
•Leptomeningeal disease as a manifestation of cancer
•Active infection requiring IV antibiotics
•Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs, inhaled steroids, or the equivalent of \<= 10 mg/day of prednisone
•Known clinically significant history of liver disease, including active viral, alcoholic, or other hepatitis, or cirrhosis

Arms & Interventions

B

Intervention: bevacizumab

A

Intervention: GDC-0980

A

Intervention: paclitaxel

B

Intervention: GDC-0980

B

Intervention: paclitaxel

Outcomes

Primary Outcomes

Incidence and nature of dose-limiting toxicities (DLTs)

Time Frame: Through Day 22

Incidence, nature, and severity of adverse events

Time Frame: Through study completion, up to 1 year, or early discontinuation

Secondary Outcomes

Pharmacokinetic parameters of GDC-0980, paclitaxel and bevacizumab (including total exposure, maximum and minimum plasma concentration, time to maximum observed plasma concentration, plasma half-life)(Through Day 22)
Duration of response(Assessed at periodic intervals until study completion, up to 1 year, or early discontinuation)
Progression-free survival (PFS)(Assessed at periodic intervals until study completion, up to 1 year, or early discontinuation)
Objective tumor response(Assessed at periodic intervals until study completion, up to 1 year, or early discontinuation)