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 currently recruiting participants.
Verified January 2013 by Genentech
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00960960
First received: August 13, 2009
Last updated: January 10, 2013
Last verified: January 2013
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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 with intravenous (IV) paclitaxel with and without and IV bevacizumab or IV trastuzumab in patients with locally recurrent or metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Breast Cancer, Locally Recurrent Breast Cancer |
Drug: bevacizumab Drug: GDC-0941 Drug: paclitaxel Drug: trastuzumab |
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 ]
| Estimated Enrollment: | 64 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: bevacizumab
Intravenous repeating dose
Drug: GDC-0941
Oral repeating dose
Drug: paclitaxel
Intravenous repeating dose
Drug: trastuzumab
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00960960
Contacts
| Contact: Please reference Study ID Number: GDC4629g www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| United States, Massachusetts | |
| Recruiting | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Tennessee | |
| Recruiting | |
| Nashville, Tennessee, United States, 97232 | |
| Belgium | |
| Recruiting | |
| Leuven, Belgium, 3000 | |
| Italy | |
| Recruiting | |
| Milano, 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: | January 10, 2013 |
| 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 Paclitaxel Trastuzumab Bevacizumab Tubulin Modulators Antimitotic Agents Mitosis Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013