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NCT03781986 · ClinicalTrials.gov registry record · Phase 1
APG-115 in Salivary Gland Cancer Trial
A Phase 1 study of Salivary Gland Cancer and Malignant Salivary Gland Cancer, sponsored by University of Michigan Rogel Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
- 3
- Study locations
NCT03781986: Active Phase 1 study of Salivary Gland Cancer and Malignant Salivary Gland Cancer, sponsored by University of Michigan Rogel Cancer Center.
NCT03781986 is a Phase 1 study of Salivary Gland Cancer and Malignant Salivary Gland Cancer that is active but no longer recruiting, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 41 participants, below the 60-participant average among 8 other Salivary Gland Cancer trials with a reported enrollment target (32% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03781986, a Phase 1 study of Salivary Gland Cancer and Malignant Salivary Gland Cancer, is active but no longer recruiting, sponsored by University of Michigan Rogel Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a phase I/II trial to evaluate the efficacy of APG-115 +/- Carboplatin for the treatment p53 wild-type malignant salivary gland cancer. Part 1 consisted of 2 arms, arm A (APG-115 monotherapy) and arm B (APG-115 + Carboplatin) and was terminated early. Part 2 is a single arm study (APG-115 monotherapy).
Primary Outcome
DLT will be defined based on the rate of drug-related grade 3-5 adverse events experienced within the first 6 weeks (2 cycles) of study treatment. These will be assessed via CTCAE version 5.0
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG APG-115
Study Locations (3)
Florida
- Moffitt Cancer Center - Tampa
Illinois
- University of Chicago - Chicago
Michigan
- University of Michigan Rogel Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2019-10-28 |
| Est. Completion | 2027-01 |
| Phase | Phase 1 |
What the registry record for NCT03781986 still lists
NCT03781986 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 8 other Salivary Gland Cancer trials with a reported enrollment target (32% lower).
The record links to 2 conditions, with Salivary Gland Cancer appearing as the primary indexed condition, and to 2 interventions - of which Carboplatin is the first listed.
NCT03781986 reports a single indexed study location in Florida, Illinois, Michigan.
Frequently Asked Questions
What is clinical trial NCT03781986 about?
NCT03781986 is a clinical study titled "APG-115 in Salivary Gland Cancer Trial". This is a phase I/II trial to evaluate the efficacy of APG-115 +/- Carboplatin for the treatment p53 wild-type malignant salivary gland cancer. Part 1 consisted of 2 arms, arm A (APG-115 monotherapy) and arm B (APG-115 + Carboplatin) and was terminated early. Part 2 is a single arm study (APG-115 ...
What is the current status of trial NCT03781986?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2019-10-28. Estimated completion is 2027-01.
What conditions does trial NCT03781986 study?
This clinical trial studies the following conditions: Salivary Gland Cancer, Malignant Salivary Gland Cancer.
What interventions are being tested in trial NCT03781986?
The interventions under investigation include: Carboplatin (DRUG), APG-115 (DRUG).
Who is sponsoring clinical trial NCT03781986?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03781986 being conducted?
This trial has 3 study locations across Florida, Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03781986's enrollment target sits among peer trials
41 5th of 8 higher than 4 of 8 other Salivary Gland Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Salivary Gland 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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