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NCT03684811 · ClinicalTrials.gov registry record · Phase 1
A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
A Phase 1 study, sponsored by Forma Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 93
- Enrollment target
NCT03684811 is a Phase 1 study that has completed, run by Forma Therapeutics. The registered enrollment target is 93 participants.
The verdict
NCT03684811, a Phase 1 study, has completed, sponsored by Forma Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 93 participants
- Enrollment target
Study Summary
This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single agent and in combination with other anti-cancer drugs in patients with advanced solid tumors and gliomas. The study is divided into two parts: single agent FT-2102 followed by combination therapy. Part 1: A single agent, open-label study in up to five cohorts (glioma, hepatobiliary tumors, chondrosarcoma, intrahepatic cholangiocarcinoma, and other IDH1 mutant solid tumors) that will include a Phase 1 dose confirmation followed by a Phase 2 investigation of clinical activity in up to 4 cohorts. During the dose confirmation, additional doses or altered dose schedules may be explored. Part 2: An open-label study of FT-2102 in combination with other anti-cancer agents. Patients will be enrolled across 4 different disease cohorts, examining the effect of FT-2102 + azacitidine (glioma and chondrosarcoma), FT-2102 + nivolumab (hepatobiliary tumors), and FT-2102 + gemcitabine/cisplatin (intrahepatic cholangiocarcinoma). There will be a safety lead-in followed by a Phase 2 evaluation in up to four cohorts of patients.
Interventions
- DRUG Azacitidine
- BIOLOGICAL Nivolumab
- DRUG FT-2102
- DRUG Gemcitabine and Cisplatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2018-11-01 |
| Est. Completion | 2022-06-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03684811
The ClinicalTrials.gov registry entry for NCT03684811 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forma Therapeutics, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Azacitidine is the first listed.
NCT03684811 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03684811 about?
NCT03684811 is a clinical study titled "A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation". This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single agent and in combination with other anti-cancer drugs in patients with advanced solid tumors and gliomas. The study is divided into two parts: single agent FT-2102 followed by combination therapy. Part 1: A ...
What is the current status of trial NCT03684811?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 93 participants. The study started on 2018-11-01. Estimated completion is 2022-06-13.
What interventions are being tested in trial NCT03684811?
The interventions under investigation include: Azacitidine (DRUG), Nivolumab (BIOLOGICAL), FT-2102 (DRUG), Gemcitabine and Cisplatin (DRUG).
Who is sponsoring clinical trial NCT03684811?
This trial is sponsored by Forma Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
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