A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Front-line Treatment for Patients With Metastatic Triple-Negative Breast Cancer
This study is currently recruiting participants.
(see Contacts and Locations)
Verified February 2015 by Genentech, Inc.
Sponsor:
Genentech, Inc.
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT02162719
First received: June 11, 2014
Last updated: February 17, 2015
Last verified: February 2015
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Purpose
This multicenter, randomized, double-blind study will estimate the efficacy of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in patients with inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC), as measured by progression-free survival in all patients and in patients with phosphatase and tensin homolog (PTEN)-low tumors. The safety and tolerability profile of ipatasertib combined with paclitaxel versus placebo combined with paclitaxel will be assessed.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Ipatasertib Drug: Paclitaxel Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A RANDOMIZED, PHASE II, MULTI-CENTER, PLACEBO-CONTROLLED STUDY OF IPATASERTIB (GDC-0068), AN INHIBITOR OF AKT, IN COMBINATION WITH PACLITAXEL AS FRONT-LINE TREATMENT FOR PATIENTS WITH METASTATIC TRIPLE-NEGATIVE BREAST CANCER |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Paclitaxel
U.S. FDA Resources
Further study details as provided by Genentech, Inc.:
Primary Outcome Measures:
- Progression-free survival (RECIST v1.1) [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival (OS) [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
- Confirmed objective tumor response in patients with measurable disease at baseline [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
- Duration of confirmed objective response in patients with measurable disease at baseline [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | August 2014 |
| Estimated Study Completion Date: | May 2016 |
| Estimated Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Paclitaxel + Ipatasertib
|
Drug: Ipatasertib
Administered orally 400 mg daily Days 1-21 of each 28-day cycle
Other Name: GDC-0068
|
|
Active Comparator: Arm 2
Paclitaxel + Placebo
|
Drug: Paclitaxel
80 mg/m2 administered by IV infusion on Days 1, 8, and 15 of each cycle
Drug: Placebo
Administered orally daily Days 1-21 of each 28-day cycle
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically documented triple-negative adenocarcinoma of the breast that is inoperable locally advanced or metastatic and is not amenable to resection with curative intent
- Premenopausal or postmenopausal women aged >/=18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen, required prior to randomization
- Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1
- Adequate hematologic and organ function within 14 days before the first study treatment
- For female patients of childbearing potential, agreement (by both patient and partner) to use an effective form of contraception for the duration of the study and for 6 months after last dose of study treatment
Exclusion Criteria:
- Any previous therapy, including chemotherapy or hormonal or targeted therapy, for inoperable locally advanced or metastatic triple-negative adenocarcinoma of the breast
- Patients may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation treatment for locally advanced triple negative adenocarcinoma, provided all treatments were completed >/= 6 months prior to Cycle 1 Day 1
- Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1
- Known HER2 positive, ER positive, or PR positive breast cancer
- Previous therapy with Akt, PI3K, and/or mTOR inhibitors
- Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study
- Known presence of the brain or spinal cord metastasis, as determined by CT or magnetic resonance imaging (MRI) evaluation during screening or prior radiographic assessments
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: NCT02162719
Show 59 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02162719
Contacts
| Contact: Reference Study ID Number: GO29227 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | global.rochegenentechtrials@roche.com |
Show 59 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT02162719 History of Changes |
| Other Study ID Numbers: | GO29227, 2014-000469-35 |
| Study First Received: | June 11, 2014 |
| Last Updated: | February 17, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Breast Neoplasms Triple Negative Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Paclitaxel Antimitotic Agents |
Antineoplastic Agents Antineoplastic Agents, Phytogenic Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses Tubulin Modulators |
ClinicalTrials.gov processed this record on February 27, 2015