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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence and nature of dose-limiting toxicities (DLTs)

Outcome Time Frame:

Through Day 22

Safety Issue:

No

Principal Investigator

Jennifer Lauchle, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

PIM4880g

NCT ID:

NCT01254526

Start Date:

December 2010

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Nashville, Tennessee  37203-1632
Boston, Massachusetts