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NCT05772546 · ClinicalTrials.gov registry record · Phase 2
Avatrombopag vs. Placebo for CIT in GI Malignancies
A Phase 2 study of Gastrointestinal Cancer and Gastrointestinal Neoplasms, sponsored by Hanny Al-Samkari, MD.
- Active
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 4
- Study locations
NCT05772546: Active Phase 2 study of Gastrointestinal Cancer and Gastrointestinal Neoplasms, sponsored by Hanny Al-Samkari, MD.
NCT05772546 is a Phase 2 study of Gastrointestinal Cancer and Gastrointestinal Neoplasms that is active but no longer recruiting, run by Hanny Al-Samkari, MD. The registered enrollment target is 60 participants, below the 229-participant average among 49 other Gastrointestinal Cancer trials with a reported enrollment target (74% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05772546, a Phase 2 study of Gastrointestinal Cancer and Gastrointestinal Neoplasms, is active but no longer recruiting, sponsored by Hanny Al-Samkari, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this study is to compare the efficacy of two study drugs, Avatrobopag versus placebo, to treat persistent Chemotherapy-Induced Thrombocytopenia (CIT) in patients with gastrointestinal (GI) malignancies receiving cytotoxic chemotherapy. The names of the study drugs involved in this study are: * Avatrombopag (a thrombopoietin receptor agonist) * Matching placebo
Primary Outcome
The primary endpoint of this study is the comparison of the response rate between the avatrombopag arm and the placebo arm. A response is defined as achieving a platelet count ≥100,000/µL within the 2 week lead-in period and then finishing at least 1 cycle of chemotherapy without CIT recurrence (no on-cycle dose-reduction or treatment delay due to thrombocytopenia and ability to receive another cycle of chemotherapy without dose-reduction or treatment delay, defined as platelet count of ≥100,000
Conditions Studied
Interventions
- DRUG Matching Placebo
- DRUG Avatrombopag
Study Locations (4)
Florida
- University of Miami Sylvester Comprehensive Cancer Center - Miami
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
Oregon
- Oregon Health and Science University Hospital - Portland
Washington
- University of Washington Fred Hutchinson Cancer Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-11-01 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 2 |
What the registry record for NCT05772546 still lists
NCT05772546 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 229-participant average among 49 other Gastrointestinal Cancer trials with a reported enrollment target (74% lower).
The record links to 3 conditions, with Gastrointestinal Cancer appearing as the primary indexed condition, and to 2 interventions - of which Matching Placebo is the first listed.
NCT05772546 reports a single indexed study location in Florida, Massachusetts, Oregon.
Frequently Asked Questions
What is clinical trial NCT05772546 about?
NCT05772546 is a clinical study titled "Avatrombopag vs. Placebo for CIT in GI Malignancies". The purpose of this study is to compare the efficacy of two study drugs, Avatrobopag versus placebo, to treat persistent Chemotherapy-Induced Thrombocytopenia (CIT) in patients with gastrointestinal (GI) malignancies receiving cytotoxic chemotherapy. The names of the study drugs involved in this st...
What is the current status of trial NCT05772546?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2023-11-01. Estimated completion is 2026-07-31.
What conditions does trial NCT05772546 study?
This clinical trial studies the following conditions: Gastrointestinal Cancer, Gastrointestinal Neoplasms, Chemotherapy Induced Thrombocytopenia.
What interventions are being tested in trial NCT05772546?
The interventions under investigation include: Matching Placebo (DRUG), Avatrombopag (DRUG).
Who is sponsoring clinical trial NCT05772546?
This trial is sponsored by Hanny Al-Samkari, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05772546 being conducted?
This trial has 4 study locations across Florida, Massachusetts, Oregon, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05772546's enrollment target sits among peer trials
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