A Study 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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00960960
First received: August 13, 2009
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of oral (PO) GDC-0941 administered w ith intravenous (IV) paclitaxel with and without and IV bevacizumab or IV trastu zumab in patients with locally recurrent or metastatic breast cancer.


Condition Intervention Phase
Metastatic Breast Cancer, Locally Recurrent Breast Cancer
Drug: trastuzumab
Drug: bevacizumab
Drug: GDC-0941
Drug: paclitaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Incidence, nature, and severity of adverse events [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PK parameters of GDC-0941 and paclitaxel (total exposure, and maximum and minimum serum concentrations) [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • Tumor response [ Time Frame: Assessed at periodic intervals ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: August 2009
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: trastuzumab
Intravenous repeating dose
Drug: bevacizumab
Intravenous repeating dose
Drug: GDC-0941
Oral repeating dose
Drug: paclitaxel
Intravenous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00960960

Locations
United States, Illinois
Peoria, Illinois, United States, 61615
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, Tennessee
Nashville, Tennessee, United States, 37232
Belgium
Leuven, Belgium, 3000
Italy
Milano, Lombardia, Italy, 20133
Sponsors and Collaborators
Genentech
Investigators
Study Director: Gallia Levy, M.D., Ph.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00960960     History of Changes
Other Study ID Numbers: GDC4629g, GO01304
Study First Received: August 13, 2009
Last Updated: September 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
MBC
PI3K
Avastin
Herceptin

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Trastuzumab
Paclitaxel
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014