Phase Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast Cancer
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ClinicalTrials.gov Identifier: NCT02390427 |
Recruitment Status :
Active, not recruiting
First Posted : March 17, 2015
Last Update Posted : February 28, 2024
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Tracking Information | ||||
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First Submitted Date ICMJE | March 11, 2015 | |||
First Posted Date ICMJE | March 17, 2015 | |||
Last Update Posted Date | February 28, 2024 | |||
Actual Study Start Date ICMJE | April 20, 2015 | |||
Actual Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Maximum Tolerated Dose (MTD) of Taselisib in combination with anti-HER2 therapy(ies) and/or paclitaxel. [ Time Frame: 28 Days ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Phase Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast Cancer | |||
Official Title ICMJE | Phase Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast Cancer | |||
Brief Summary | This research study is a way of gaining new knowledge about the combination of Taselisib with other drugs in the treatment of metastatic breast cancer. Taselisib is an investigational drug which works by blocking a protein called PI3K (phosphoinositide 3-kinase) that helps cancer cells grow. This drug has been used in laboratory experiments and information from these studies suggests that this drug may help to prevent or slow the growth of cancer cells. The main purpose of this study is to find the appropriate dose of Taselisib to be used with other drugs in further clinical studies. This is an open-label, 3+3 dose-escalation phase Ib study to identify the Maximum Tolerated Dose(s) (MTD) and to identify the recommended phase 2 dose (RP2D) of Taselisib. This study will be conducted in 4 separate arms. (A-D). | |||
Detailed Description | This study is divided in two parts, a combination dose finding escalation part (Part 1) and a dose combination expansion part (Part 2). Participants will enter only one Part (either 1 or 2) and receive study drugs from only one combindation of study drugs, know as arms, as assigned by the main study physician. The study includes four different arms as listed below:
Part 1: Since we are looking for the highest dose of Taselisib that can be administered safely without severe or unmanageable side effects in participants that have breast cancer, not everyone who participates in Part 1 of this research study will receive the same dose of the Taselisib. The dose participants get will depend on the number of participants who have been enrolled in the study before and how well they have tolerated their doses. Each combination dose will only be given to a group of 3 - 6 participants. The results from each group will be reviewed and depending on the results, a different combination dose or schedule may be investigated in the next group of participants or the same combination dose taken by a participant may be repeated with the next group of participants to investigate these results further (a different schedule means that instead of taking doses once every day, participants may take them only on some days in the week). Part 2: The doses in this part will be based on the best combination doses from Part 1. This part will look at the potential side effects and see how your cancer responds to the drug. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
68 | |||
Original Estimated Enrollment ICMJE |
76 | |||
Estimated Study Completion Date ICMJE | May 2024 | |||
Actual Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02390427 | |||
Other Study ID Numbers ICMJE | 15-024 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Otto Metzger, MD, Dana-Farber Cancer Institute | |||
Original Responsible Party | Ian E. Krop, MD, PhD, Dana-Farber Cancer Institute, Principal Investigator | |||
Current Study Sponsor ICMJE | Otto Metzger, MD | |||
Original Study Sponsor ICMJE | Dana-Farber Cancer Institute | |||
Collaborators ICMJE | Genentech, Inc. | |||
Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | |||
Verification Date | February 2024 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |