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ACTIVE NOT RECRUITING Phase 1

Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma

NCT06478212 · View on ClinicalTrials.gov ↗

Study Summary

The objective of this study is to determine the safety and tolerability of vorasidenib in combination with temozolomide (TMZ) and to establish the recommended combination dose (RCD) of vorasidenib. The study will begin as a Phase Ib study to determine the RCD and then will transition to a Phase II study to assess the clinical efficacy of vorasidenib at the RCD in combination with TMZ. During the treatment period participants will have study visits on day 1 and 22 of each cycle, with additional visits occurring during the first cycle of the Phase 1b study. Approximately 30 days after treatment has ended, a safety follow-up visit will occur and then participants will be followed for survival every 3 months. Study visits may include questionnaires, blood tests, ECG, vital signs, and a physical examination.

Interventions

  • DRUG Temozolomide (TMZ)
  • DRUG Vorasidenib

Study Locations (20)

Other

  • Medical University of Vienna - AKH — Vienna
  • Beijing Tiantan Hospital, Capital Medical University — Beijing
  • Huashan Hospital, Fudan University — Shanghai
  • Hôpital Pierre Wertheimer — Lyon
  • Hôpital Pitié-Salpêtrière — Paris
  • IUCT-Oncopole Institut Universitaire du Cancer — Toulouse
  • Universitätsklinikum Heidelberg — Heidelberg
  • Medizinische Fakultät Mannheim, Universität Heidelberg — Mannheim
  • Universitätsklinikum Regensburg — Regensburg
  • The Tel Aviv Sourasky Medical Center (TASMC) (Ichilov Hospital) — Tel Aviv
  • IOV - Ospedale Busonera — Padua
  • Ospedale Molinette - Centro Oncologico Ematologico — Turin
  • Kumamoto University Hospital — Kumamoto

California

  • University of California Los Angeles — Los Angeles

Florida

  • University of Miami — Miami

Massachusetts

  • Dana Farber Cancer Institute — Boston

New York

  • Memorial Sloan Kettering Cancer Center — New York

North Carolina

  • Duke University Medical Center — Durham

Texas

  • MD Anderson Cancer Center — Houston

Milan

  • Instituto Clinico Humanitas IRCCS — Rozzano

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2025-01-22
Est. Completion 2028-06
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06478212

The ClinicalTrials.gov registry entry for NCT06478212 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Institut de Recherches Internationales Servier, which has 16 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with IDH1-mutant Glioma appearing as the primary indexed condition, and to 2 interventions — of which Temozolomide (TMZ) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06478212 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06478212 about?

NCT06478212 is a clinical study titled "Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma". The objective of this study is to determine the safety and tolerability of vorasidenib in combination with temozolomide (TMZ) and to establish the recommended combination dose (RCD) of vorasidenib. The study will begin as a Phase Ib study to determine the RCD and then will transition to a Phase II s...

What is the current status of trial NCT06478212?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2025-01-22. Estimated completion is 2028-06.

What conditions does trial NCT06478212 study?

This clinical trial studies the following conditions: IDH1-mutant Glioma, IDH2-mutant Glioma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06478212?

The interventions under investigation include: Temozolomide (TMZ) (DRUG), Vorasidenib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06478212?

This trial is sponsored by Institut de Recherches Internationales Servier, which has 16 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06478212 being conducted?

This trial has 20 study locations across California, Florida, Massachusetts, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial