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A Study Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants With Breast Cancer That Has Spread Beyond the Initial Site, and the Cancer Does Not Have Certain Hormonal Receptors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162719
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE June 11, 2014
First Posted Date  ICMJE June 13, 2014
Last Update Posted Date September 2, 2020
Actual Study Start Date  ICMJE August 19, 2014
Actual Primary Completion Date June 6, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2020)
  • Progression Free Survival (PFS) [ Time Frame: Baseline up to Primary Completion Date (07 June 2016) ]
  • PFS in Subjects with Phosphatase and Tensin Homolog (PTEN)-Low Tumors [ Time Frame: Baseline up to Primary Completion Date (07 June 2016) ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
Progression-free survival (RECIST v1.1) [ Time Frame: Up to 24 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2020)
  • PFS in Subjects with Phosphatidylinositol-4,5-bisphosphate 3-kinase Catalytic Subunit Alpha (PIK3CA)/ Protein Kinase B (AKT1)/ PTEN-altered Tumors [ Time Frame: Baseline up to Primary Completion Date (07 June 2016) ]
  • Overall Survival (OS) [ Time Frame: Baseline up to Clinical Cut Off Date (31 August 2019) ]
  • OS in Participants with PTEN-Low Tumors [ Time Frame: Baseline up to Clinical Cut Off Date (31 August 2019) ]
  • OS in Subjects with PIK3CA/AKT1/PTEN-altered Tumors [ Time Frame: Baseline up to Clinical Cut Off Date (31 August 2019) ]
  • Objective Response Rate (ORR) [ Time Frame: Baseline up to Primary Completion Date (07 June 2016) ]
  • ORR in Subjects with PTEN-Low Tumors [ Time Frame: Baseline up to Primary Completion Date (07 June 2016) ]
  • ORR in Subjects with PIK3CA/AKT1/PTEN-altered Tumors [ Time Frame: Baseline up to Primary Completion Date (07 June 2016) ]
  • Duration of Response [ Time Frame: Baseline up to Primary Completion Date (07 June 2016) ]
  • Duration of Response in Subjects with PTEN-Low Tumors [ Time Frame: Baseline up to Primary Completion Date (07 June 2016) ]
  • Duration of Response in Subjects with PIK3CA/AKT1/PTEN-altered Tumors [ Time Frame: Baseline up to Primary Completion Date (07 June 2016) ]
  • Time to Disease Progression [ Time Frame: Baseline up to Primary Completion Date (07 June 2016) ]
  • Time to Disease Progression in Subjects with PTEN-Low Tumors [ Time Frame: Baseline up to Primary Completion Date (07 June 2016) ]
  • Time to Disease Progression in Subjects with PIK3CA/AKT1/PTEN-altered Tumors [ Time Frame: Baseline up to Primary Completion Date (07 June 2016) ]
  • Percentage of Participants with Adverse Events [ Time Frame: Baseline up to approximately 2.5 years ]
  • Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 24 Hours (AUC0-24h) of Ipatasertib [ Time Frame: Cycle 1 Day 1, Cycle 1 Day 8 ]
  • Apparent Clearance Following Oral Dosing (CL/F) of Ipatasertib [ Time Frame: Cycle 1 Day 1, Cycle 1 Day 8 ]
  • Mean Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score [ Time Frame: Baseline (Cycle 1 Day 1) up to Cycle 5 Day 1 ]
  • Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30 [ Time Frame: Baseline (Cycle 1 Day 1) up to Cycle 5 Day 1 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
  • Overall survival (OS) [ Time Frame: Up to 24 months ]
  • Confirmed objective tumor response in patients with measurable disease at baseline [ Time Frame: Up to 24 months ]
  • Duration of confirmed objective response in patients with measurable disease at baseline [ Time Frame: Up to 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants With Breast Cancer That Has Spread Beyond the Initial Site, and the Cancer Does Not Have Certain Hormonal Receptors
Official Title  ICMJE 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
Brief Summary This multicenter, randomized, double-blind study will estimate the efficacy, safety and tolerability of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in participants with inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC), as measured by progression-free survival (PFS) in all participants and in participants with phosphatase and tensin homolog (PTEN)-low tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • Drug: Ipatasertib
    Participants will receive ipatasertib orally 400 milligrams (mg) daily on Days 1-21 of each 28-day cycle.
    Other Name: GDC-0068
  • Drug: Paclitaxel
    Participants will receive paclitaxel 80 milligrams per square meter (mg/m^2) intravenously (IV) on Days 1, 8, and 15 of each cycle.
  • Drug: Placebo
    Participants will receive oral placebo matched to ipatasertib, daily on Days 1-21 of each 28-day cycle.
Study Arms  ICMJE
  • Experimental: Ipatasertib + Paclitaxel
    Participants will receive ipatasertib and paclitaxel in cycles of 28 days (4 weeks) each and study treatment will continue until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
    Interventions:
    • Drug: Ipatasertib
    • Drug: Paclitaxel
  • Placebo Comparator: Placebo + Paclitaxel
    Participants will receive placebo and paclitaxel in cycles of 28 days (4 weeks) each and study treatment will continue until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
    Interventions:
    • Drug: Paclitaxel
    • Drug: Placebo
Publications * Kim SB, Dent R, Im SA, Espié M, Blau S, Tan AR, Isakoff SJ, Oliveira M, Saura C, Wongchenko MJ, Kapp AV, Chan WY, Singel SM, Maslyar DJ, Baselga J; LOTUS investigators. Ipatasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer (LOTUS): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2017 Oct;18(10):1360-1372. doi: 10.1016/S1470-2045(17)30450-3. Epub 2017 Aug 8. Erratum in: Lancet Oncol. 2018 Dec;19(12):e667.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 3, 2016)
124
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2014)
120
Actual Study Completion Date  ICMJE August 31, 2019
Actual Primary Completion Date June 6, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • 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 RECIST v1.1
  • Adequate hematologic and organ function within 14 days before the first study treatment
  • For female participants of childbearing potential, agreement (by both participant 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. Participants may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation treatment for locally advanced triple negative adenocarcinoma, provided all treatments were completed greater than or equal to (>/=) 6 months prior to Cycle 1 Day 1. Locally recurrent disease must not be amenable to resection with curative intent
  • Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1
  • Known Human Epidermal Growth Factor Receptor 2 (HER2) positive, erythrocyte receptor (ER) positive, or progesterone receptor (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 computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or prior radiographic assessments
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Italy,   Korea, Republic of,   Singapore,   Spain,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02162719
Other Study ID Numbers  ICMJE GO29227
2014-000469-35 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP