Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    CO40151
Previous Study | Return to List | Next Study

A Study to Evaluate the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03800836
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This is a Phase Ib, open-label, multicenter study evaluating the safety and efficacy of ipatasertib in combination with atezolizumab and paclitaxel or nab-paclitaxel for patients with locally advanced or metastatic triple-negative breast cancer (mTNBC) who have not previously received chemotherapy in the advanced setting. Two triplets; ipatasertib in combination with atezolizumab and paclitaxel (Paclitaxel arm) and ipatasertib in combination with atezolizumab and nab-paclitaxel (Nab-Paclitaxel arm) are being evaluated for first-line chemotherapy treatment for advanced TNBC. Cohort 1 will evaluate first-line chemotherapy treatment in advanced TNBC patients and Cohort 2 will contain biopsy assessments of TNBC patients who have progressed after at least one line of chemotherapy in the advanced setting.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Ipatasertib Drug: Paclitaxel Drug: Atezolizumab Drug: Nab-Paclitaxel Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer
Actual Study Start Date : February 13, 2018
Estimated Primary Completion Date : October 29, 2019
Estimated Study Completion Date : October 29, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Paclitaxel Arm: Ipatasertib + Atezolizumab + Paclitaxel
Participants will receive ipatasertib orally daily on Days 1-21 of each 28 day cycle, and atezolizumab will be administered by intravenous (IV) infusion on Days 1 and 15 of each 28 day cycle. Paclitaxel will be administered by IV infusion on Days 1, 8, and 15 of each 28 day cycle. All patients in this study will continue to be treated until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
Drug: Ipatasertib
Ipatasertib will be administered at a dose of 400 milligrams (mg) orally daily on Days 1-21 of each 28 day cycle.

Drug: Paclitaxel
Paclitaxel will be administered at a dose of 80 milligrams per square meter (mg/m^2) as IV infusion on Days 1, 8, and 15 of each 28 day cycle.

Drug: Atezolizumab
Atezolizumab will be administered by IV infusion at a fixed dose of 840 mg on Days 1 and 15 of each 28 day cycle.

Experimental: Nab-Paclitaxel Arm: Ipatasertib+Atezolizumab+Nab-Paclitaxel
Participants will receive ipatasertib orally daily on Days 1-21 of each 28 day cycle, and atezolizumab will be administered by IV infusion on Days 1 and 15 of each 28 day cycle. Nab-paclitaxel will be administered by IV infusion on Days 1, 8, and 15 of each 28 day cycle. All patients in this study will continue to be treated until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
Drug: Ipatasertib
Ipatasertib will be administered at a dose of 400 milligrams (mg) orally daily on Days 1-21 of each 28 day cycle.

Drug: Atezolizumab
Atezolizumab will be administered by IV infusion at a fixed dose of 840 mg on Days 1 and 15 of each 28 day cycle.

Drug: Nab-Paclitaxel
Nab-paclitaxel will be administered by IV infusion at a dose of 100 mg/m^2 on Days 1, 8, and 15 of each 28 day cycle.




Primary Outcome Measures :
  1. Cohort 1: Percentage of Participants with Objective Response (Complete Response [CR] or Partial Response [PR]), as Assessed by Investigator Based on Response Evaluation Criteria in Solid Tumors (RECIST), Version (v) 1.1 [ Time Frame: Baseline up to disease progression or treatment discontinuation, whichever occurs first (to approximately 12 months) ]
  2. Cohort 1: Duration of Confirmed Objective Response, as Determined by the Investigator According to RECIST v1.1 [ Time Frame: Baseline up to disease progression or death due to any cause whichever occurs first (up to approximately 12 months) ]

Secondary Outcome Measures :
  1. Cohort 1: Progression-Free Survival, as Assessed by Investigator Based on RECIST v1.1 [ Time Frame: Baseline up to disease progression or death due to any cause whichever occurs first (up to approximately 12 months) ]
  2. Cohort 1: Percentage of Participants who have an Objective Response (Complete or Partial), or Stable Disease for at least 24 weeks, as Assessed by Investigator Based on RECIST v1.1 [ Time Frame: Baseline up to disease progression or death due to any cause whichever occurs first (up to approximately 12 months) ]
  3. Cohort 1: Overall Survival in All Participants [ Time Frame: Baseline up to disease progression or death due to any cause whichever occurs first (up to approximately 12 months) ]
  4. Cohort 1: Plasma Concentration of Ipatasertib [ Time Frame: At Day 1 and Day 15 of Cycles 1-3, and Day 1 of Cycle 4 (each cycle is 28 days) ]
  5. Cohort 1: Plasma Concentration of Ipatasertib's Metabolite (G-037720) [ Time Frame: At Day 1 and Day 15 of Cycles 1-3, and Day 1 of Cycle 4 (each cycle is 28 days) ]
  6. Cohort 1: Presence of Anti-Drug Antibody During Study Treatment [ Time Frame: At Day 1 and Day 15 of Cycles 1-3, and Day 1 of Cycle 4 (each cycle is 28 days) ]
  7. Cohort 1: Plasma Concentration of Atezolizumab [ Time Frame: At Day 1 and Day 15 of Cycles 1-3, and Day 1 of Cycle 4 (each cycle is 28 days) ]
  8. Cohort 1 and Cohort 2: Percentage of Participants with Adverse Events [ Time Frame: Baseline up to disease progression or death due to any cause whichever occurs first (up to approximately 12 months) ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Adequate hematologic and organ function
  • Life expectancy of at least 6 months
  • For men and women of child bearing potential: agreement to remain abstinent or use protocol defined contraceptive measures during the treatment period and for at least 28 days after the last dose of ipatasertib, 6 months after the last dose of paclitaxel, and 5 months after the last dose of atezolizumab, whichever occurs later
  • Histologically documented TNBC that is locally advanced or metastatic
  • Measurable disease according to RECIST v1.1

Exclusion Criteria:

  • History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills
  • Active infection
  • History of or current evidence of HIV infection
  • Known clinically significant history of liver disease
  • Pregnant or breastfeeding
  • Left ventricular ejection fraction < 50%
  • Prior treatment with an Akt inhibitor
  • History of or known presence of brain or spinal cord metastases
  • Patients may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation treatment for early stage breast cancer, provided all chemotherapy was completed >= 12 months prior to Day 1 of Cycle 1
  • Uncontrolled tumor related complications
  • Malignancies other than breast cancer within 5 years prior to Day 1 of Cycle 1
  • History of Type I or Type II diabetes mellitus requiring insulin
  • Uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia
  • History of or active inflammatory bowel disease or active bowel inflammation
  • Clinically significant lung disease
  • Treatment with strong CYP3A inhibitors or strong CYP3A inducers
  • Active or history of autoimmune disease or immune deficiency
  • Prior allogeneic stem cell or solid organ transplantation
  • History of hypersensitivity reactions to study drug or any component of the study drug formulation
  • Treatment with systemic immunostimulatory agents and immunosuppressive medication treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study
  • Grade >= 2 peripheral neuropathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800836


Contacts
Layout table for location contacts
Contact: Reference Study ID Number: CO40151 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

Locations
Layout table for location information
United States, California
Pacific Shores Medical Group Recruiting
Long Beach, California, United States, 90813
United States, Washington
Northwest Medical Specialties Withdrawn
Tacoma, Washington, United States, 98405
Australia, New South Wales
St Vincents Hospital; Cardiopulmonary transplant Ambulatory Care Dept Recruiting
Darlinghurst, New South Wales, Australia, 2010
Australia, Victoria
Austin Hospital Recruiting
Heidelberg, Victoria, Australia, 3084
Peter MacCallum Cancer Center Recruiting
Melbourne, Victoria, Australia, 3000
France
Institut de Cancerologie de l Ouest Recruiting
Angers, France, 49055
Institut Bergonie Recruiting
Bordeaux, France, 33076
Centre Georges Francois Leclerc Recruiting
Dijon, France, 21000
Institut Curie Recruiting
Paris, France, 75005
Gustave Roussy Recruiting
Villejuif CEDEX, France, 94800
Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Hospital Universitario La Paz Recruiting
Madrid, Spain, 280146
Hospital Clinico San Carlos; Servicio de Oncologia Recruiting
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica Recruiting
Madrid, Spain, 28050
Hospital Universitario Virgen del Rocío Recruiting
Madrid, Spain, 41013
United Kingdom
Barts Cancer Institute Recruiting
London, United Kingdom, E1 2AT
The Christie NHS Foundation Trust Withdrawn
Manchester, United Kingdom, M20 4BX
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche

Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03800836     History of Changes
Other Study ID Numbers: CO40151
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Atezolizumab
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs