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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254526
• Other study ID #: PIM4880g
• Secondary ID: GO00882
• Status: Completed
• Phase: Phase 1
• First received: December 1, 2010
• Last updated: November 1, 2016
• Start date: December 2010
• Est. completion date: April 2013

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• GDC-0980
Oral repeating dose
• bevacizumab
Intravenous repeating dose
• paclitaxel
Intravenous repeating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and nature of dose-limiting toxicities (DLTs)		Through Day 22	No
Primary	Incidence, nature, and severity of adverse events		Through study completion, up to 1 year, or early discontinuation	No
Secondary	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	No
Secondary	Duration of response		Assessed at periodic intervals until study completion, up to 1 year, or early discontinuation	No
Secondary	Progression-free survival (PFS)		Assessed at periodic intervals until study completion, up to 1 year, or early discontinuation	No
Secondary	Objective tumor response		Assessed at periodic intervals until study completion, up to 1 year, or early discontinuation	No