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NCT06478212RECRUITINGIRB Ready

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

Sponsored by Institut de Recherches Internationales Servier

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 42 participants interested
2% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

Be โ‰ฅ12 years of age with a weight at screening โ‰ฅ40 kg.
Have documented IDH1 or IDH2 mutation based on local testing of tumor tissue by an accredited laboratory
Have adequate renal function, defined as a creatinine clearance โ‰ฅ40 mL/min based on the Cockcroft-Gault glomerular filtration rate estimation: (140 - Age) ร— (Weight in kg) ร— (0.85 if female) / 72 ร— serum creatinine (mg/dL).
Have adequate bone marrow function as evidenced by: 1. Absolute neutrophil count โ‰ฅ1,500/mm3 or 1.5ร—109/L 2. Hemoglobin โ‰ฅ9 g/dL or 90 g/L 3. Platelets โ‰ฅ100,000/mm3 or 100ร—109/L
Have expected survival of โ‰ฅ3 months.
KPS or LPPS โ‰ฅ70 at the start of study treatment.
Participants on corticosteroids for reasons related to glioma must be on a stable or decreasing dose (โ‰ค4mg/day dexamethasone or equivalent) for โ‰ฅ5 days before the start of study treatment.
Female participants of reproductive potential must have a negative serum pregnancy test before starting study treatment.

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

42 participants

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Gender

ALL

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Sponsor

Institut de Recherches Internationales Servier

Study Locations

Choose your preferred location or select flexible during enrollment

Unknown

Los Angeles

California

Location available
View Los Angeles location page
Unknown

Miami

Florida

Location available
View Miami location page
Unknown

Boston

Massachusetts

Location available
View Boston location page
Unknown

New York

New York

Location available
View New York location page
Unknown

Durham

North Carolina

Location available
View Durham location page
Unknown

Houston

Texas

Location available
View Houston location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for IDH-mutant glioma Treatment in Los Angeles?

Join others in California exploring innovative treatment options through clinical research

IDH-mutant glioma Treatment Options in Los Angeles, California

If you're searching for IDH-mutant glioma treatment in Los Angeles, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Los Angeles, San Francisco, Miami and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with IDH-mutant glioma. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 42 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for IDH-mutant glioma?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for IDH-mutant glioma

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This IDH-mutant glioma Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06478212. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.