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NCT03528642 · ClinicalTrials.gov registry record · Phase 1
Telaglenastat With Radiation Therapy and Temozolomide in Treating Patients With IDH-Mutated Diffuse Astrocytoma or Anaplastic Astrocytoma
A Phase 1 study of Astrocytoma, IDH-Mutant, Grade 2 and Astrocytoma, IDH-Mutant, Grade 3, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 20
- Study locations
NCT03528642: Active Phase 1 study of Astrocytoma, IDH-Mutant, Grade 2 and Astrocytoma, IDH-Mutant, Grade 3, sponsored by National Cancer Institute (NCI).
NCT03528642 is a Phase 1 study of Astrocytoma, IDH-Mutant, Grade 2 and Astrocytoma, IDH-Mutant, Grade 3 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03528642, a Phase 1 study of Astrocytoma, IDH-Mutant, Grade 2 and Astrocytoma, IDH-Mutant, Grade 3, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase 1b trial studies the side effects and best dose of telaglenastat in combination with radiation therapy and temozolomide in treating patients with IDH-mutated diffuse or anaplastic astrocytoma. Telaglenastat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving telaglenastat with radiation therapy and temozolomide may work better than surgery, radiation therapy, and temozolomide in treating patients with IDH-mutated diffuse astrocytoma or anaplastic astrocytoma.
Primary Outcome
MTD is defined as the dose level below the lowest dose that induces dose limiting toxicity (DLT) in at least 2 patients (out of 6). A total of 6 patients must be treated at the MTD. It is possible that the MTD will be unknown after this study (e.g., if the highest tested dose has fewer than 2 patients with DLT, out of 6). In this case, the highest dose is defined as the RP2D. A 3 + 3 cohort expansion design to determine toxicity-based dose escalation of telaglenastat (CB-839) hydrochloride (HCl)
Conditions Studied
Interventions
- OTHER Questionnaire Administration
- RADIATION Radiation Therapy
- DRUG Temozolomide
- DRUG Telaglenastat Hydrochloride
Study Locations (20)
Missouri
- Siteman Cancer Center at Saint Peters Hospital - City of Saint Peters
- Siteman Cancer Center at West County Hospital - Creve Coeur
- Washington University School of Medicine - St Louis
- Siteman Cancer Center-South County - St Louis
- Siteman Cancer Center at Christian Hospital - St Louis
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
California
- UC San Diego Moores Cancer Center - La Jolla
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
Florida
- Mayo Clinic in Florida - Jacksonville
- Moffitt Cancer Center - Tampa
New York
- Laura and Isaac Perlmutter Cancer Center at NYU Langone - New York
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center - New York
District of Columbia
- Sibley Memorial Hospital - Washington D.C.
Iowa
- University of Iowa/Holden Comprehensive Cancer Center - Iowa City
Kentucky
- University of Kentucky/Markey Cancer Center - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-05-01 |
| Est. Completion | 2026-05-08 |
| Phase | Phase 1 |
What the registry record for NCT03528642 still lists
NCT03528642 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 2 conditions, with Astrocytoma, IDH-Mutant, Grade 2 appearing as the primary indexed condition, and to 4 interventions - of which Questionnaire Administration is the first listed.
NCT03528642 names 20 study sites across 12 states, led by Missouri, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT03528642 about?
NCT03528642 is a clinical study titled "Telaglenastat With Radiation Therapy and Temozolomide in Treating Patients With IDH-Mutated Diffuse Astrocytoma or Anaplastic Astrocytoma". This phase 1b trial studies the side effects and best dose of telaglenastat in combination with radiation therapy and temozolomide in treating patients with IDH-mutated diffuse or anaplastic astrocytoma. Telaglenastat may stop the growth of tumor cells by blocking some of the enzymes needed for cell...
What is the current status of trial NCT03528642?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2019-05-01. Estimated completion is 2026-05-08.
What conditions does trial NCT03528642 study?
This clinical trial studies the following conditions: Astrocytoma, IDH-Mutant, Grade 2, Astrocytoma, IDH-Mutant, Grade 3.
What interventions are being tested in trial NCT03528642?
The interventions under investigation include: Questionnaire Administration (OTHER), Radiation Therapy (RADIATION), Temozolomide (DRUG), Telaglenastat Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT03528642?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03528642 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03528642's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 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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