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NCT02390427 · ClinicalTrials.gov registry record · Phase 1
Phase Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast Cancer
A Phase 1 study of Metastatic Breast Cancer and Recurrent Breast Cancer, sponsored by Otto Metzger, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
- 3
- Study locations
NCT02390427: Completed Phase 1 study of Metastatic Breast Cancer and Recurrent Breast Cancer, sponsored by Otto Metzger, MD.
NCT02390427 is a Phase 1 study of Metastatic Breast Cancer and Recurrent Breast Cancer that has completed, run by Otto Metzger, MD. The registered enrollment target is 68 participants, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (67% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02390427, a Phase 1 study of Metastatic Breast Cancer and Recurrent Breast Cancer, has completed, sponsored by Otto Metzger, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
- 3
- Study locations
Study 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).
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Paclitaxel
- DRUG Trastuzumab emtansine
- DRUG Pertuzumab
- DRUG Taselisib
Study Locations (3)
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
Tennessee
- Sarah Cannon Research Institute - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2015-04-20 |
| Est. Completion | 2024-07 |
| Phase | Phase 1 |
What the finished NCT02390427 record still lists
NCT02390427 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (67% lower).
The record links to 2 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Trastuzumab is the first listed.
NCT02390427 reports a single indexed study location in Massachusetts, Tennessee.
Frequently Asked Questions
What is clinical trial NCT02390427 about?
NCT02390427 is a clinical study titled "Phase Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast Cancer". 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 dr...
What is the current status of trial NCT02390427?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2015-04-20. Estimated completion is 2024-07.
What conditions does trial NCT02390427 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer, Recurrent Breast Cancer.
What interventions are being tested in trial NCT02390427?
The interventions under investigation include: Trastuzumab (DRUG), Paclitaxel (DRUG), Trastuzumab emtansine (DRUG), Pertuzumab (DRUG), Taselisib (DRUG).
Who is sponsoring clinical trial NCT02390427?
This trial is sponsored by Otto Metzger, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02390427 being conducted?
This trial has 3 study locations across Massachusetts, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02390427's enrollment target sits among peer trials
68 72nd of 139 higher than 68 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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