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 September 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT02162719
First received: June 11, 2014
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

This multicenter, randomized, double-blind study will estimate the efficacy of i patasertib combined with paclitaxel compared with placebo combined with paclitax el in patients with inoperable locally advanced or metastatic triple-negative br east cancer (mTNBC), as measured by progression-free survival in all patients an d 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: Paclitaxel
Drug: Placebo
Drug: Ipatasertib
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:


Further study details as provided by Genentech:

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: April 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 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
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

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 56 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT02162719     History of Changes
Other Study ID Numbers: GO29227, 2014-000469-35
Study First Received: June 11, 2014
Last Updated: September 8, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014