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A Phase Ib, Open-Label, Dose-Escalation Study of the Safety And Pharmacology of PI3-Kinase Inhibitor GDC-0941 in Combination With Paclitaxel, With and Without Bevacizumab or Trastuzumab, in Patients With Locally Recurrent Or Metastatic Breast Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Metastatic Breast Cancer, Locally Recurrent Breast Cancer

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Trial Information

A Phase Ib, Open-Label, Dose-Escalation Study of the Safety And Pharmacology of PI3-Kinase Inhibitor GDC-0941 in Combination With Paclitaxel, With and Without Bevacizumab or Trastuzumab, in Patients With Locally Recurrent Or Metastatic Breast Cancer


Inclusion Criteria:



- Confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease

- Adequate organ and bone marrow function as assessed by laboratory tests

- Evaluable disease or disease measurable per Response Evaluation Criteria in Solid
Tumors (RECIST)

- Agreement to use an effective form of contraception for the duration of the study

Exclusion Criteria:

- History of Grade >/= 3 fasting hyperglycemia

- History of diabetes requiring regular medication

- History of malabsorption syndrome or other condition that would interfere with
enteral absorption

- Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or
thrombolytic agents

- Prior anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy)
within a specified timeframe of the first dose of study treatment

- Uncontrolled current illness

- Active autoimmune disease requiring the equivalent of >10 mg/day of prednisone

- Clinically significant history of liver disease, including cirrhosis, current alcohol
abuse, or current known active infection with HIV, hepatitis B virus, or hepatitis C
virus

- Known HIV infection

- New York Heart Association (NYHA) Class II or greater congestive heart failure

- Active ventricular arrhythmia requiring medication

- Pregnancy, lactation, or breastfeeding

- Known significant hypersensitivity to study drugs or excipients

- History of arterial thromboembolic disease within 6 months of first study treatment

- No more than two prior chemotherapy regimens for metastatic disease

- No prior taxane therapy for metastatic disease

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence, nature, and severity of adverse events

Outcome Time Frame:

Through study completion or early study discontinuation

Safety Issue:

No

Principal Investigator

Gallia Levy, M.D., Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

GDC4629g

NCT ID:

NCT00960960

Start Date:

August 2009

Completion Date:

October 2013

Related Keywords:

  • Metastatic Breast Cancer, Locally Recurrent Breast Cancer
  • MBC
  • PI3K
  • Avastin
  • Herceptin
  • Breast Neoplasms

Name

Location

Nashville, Tennessee  37203-1632
Boston, Massachusetts