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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

NCT ID: NCT01254526

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

GDC-0980

Intervention Type DRUG

Oral repeating dose

paclitaxel

Intervention Type DRUG

Intravenous repeating dose

B

Group Type EXPERIMENTAL

GDC-0980

Intervention Type DRUG

Oral repeating dose

bevacizumab

Intervention Type DRUG

Intravenous repeating dose

paclitaxel

Intervention Type DRUG

Intravenous repeating dose

Interventions

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GDC-0980

Oral repeating dose

Intervention Type DRUG

bevacizumab

Intravenous repeating dose

Intervention Type DRUG

paclitaxel

Intravenous repeating dose

Intervention Type DRUG

Eligibility Criteria

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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
* Known HIV infection
* Known untreated or active CNS metastases
* Pregnancy, lactation, or breastfeeding
* Major surgical procedure, open biopsy, or significant traumatic injury within a within a specified timeframe of the first dose of study treatment

For Arm B:

* Uncontrolled hypertension, complication from hypertension, myocardial infarctions, unstable angina, vascular disease or stroke within a specified timeframe of the first dose of study treatment
* Evidence of bleeding diathesis or significant coagulopathy including hemoptysis within a specified timeframe of the first dose of study treatment
* History of abdominal conditions (e.g., fistula, perforation, obstruction) that would preclude use of bevacizumab
* Serious, non-healing wound, active ulcer, or untreated bone fracture
* Proteinuria
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Lauchle, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

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Boston, Massachusetts, United States

Site Status

Nashville, Tennessee, United States

Site Status

Leuven, , Belgium

Site Status

Countries

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United States Belgium

Other Identifiers

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GO00882

Identifier Type: OTHER

Identifier Source: secondary_id

PIM4880g

Identifier Type: -

Identifier Source: org_study_id