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NCT02401815 · ClinicalTrials.gov registry record · Phase 1
CGT9486 (Formerly Known as PLX9486) as a Single Agent and in Combination With PLX3397 (Pexidartinib) or Sunitinib in Participants With Advanced Solid Tumors
A Phase 1 study, sponsored by Cogent Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT02401815: Completed Phase 1 study, sponsored by Cogent Biosciences.
NCT02401815 is a Phase 1 study that has completed, run by Cogent Biosciences. The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02401815, a Phase 1 study, has completed, sponsored by Cogent Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn how CGT9486 (fka PLX9486) may affect cancer cells with certain mutations in the KIT gene, specifically in participants with types of advanced solid tumors including gastrointestinal stromal tumor (GIST). CGT9486 (fka PLX9486) is designed to block KIT gene mutations. These mutations can cause cancer and cancer cell growth. By blocking these mutations, the drug may kill the cancer cells with the mutation and/or stop the tumor from growing. By combining CGT9486 (fka PLX9486) with PLX3397 and CGT9486 (fka PLX9486) with sunitinib, the investigators hope to block most KIT gene mutations that drive cancer growth.
Primary Outcome
RP2D was determined by incidence of dose limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events (CTCAE) V4.03. DLTs: AEs that occurred during Cycle 1, possibly/probably related to study drug, and met 1 of the following criteria: Hematologic Toxicities: Grade 4 neutropenia for \>7 days, Grade ≥3 neutropenia with fever, Grade 4 thrombocytopenia, Grade ≥3 thrombocytopenia for \>7 days, Grade 4 anemia; Other Toxicities: Any Grade ≥3 (AE or laboratory) toxicity despite adequate
Interventions
- DRUG Sunitinib
- DRUG CGT9486
- DRUG Pexidartinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2015-03-06 |
| Est. Completion | 2020-05-11 |
| Phase | Phase 1 |
What the finished NCT02401815 record still lists
NCT02401815 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 3 interventions - of which Sunitinib is the first listed.
NCT02401815 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02401815 about?
NCT02401815 is a clinical study titled "CGT9486 (Formerly Known as PLX9486) as a Single Agent and in Combination With PLX3397 (Pexidartinib) or Sunitinib in Participants With Advanced Solid Tumors". The goal of this clinical research study is to learn how CGT9486 (fka PLX9486) may affect cancer cells with certain mutations in the KIT gene, specifically in participants with types of advanced solid tumors including gastrointestinal stromal tumor (GIST). CGT9486 (fka PLX9486) is designed to block...
What is the current status of trial NCT02401815?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2015-03-06. Estimated completion is 2020-05-11.
What interventions are being tested in trial NCT02401815?
The interventions under investigation include: Sunitinib (DRUG), CGT9486 (DRUG), Pexidartinib (DRUG).
Who is sponsoring clinical trial NCT02401815?
This trial is sponsored by Cogent Biosciences, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02401815's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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