Clinical trial · Expanded Access

Vorasidenib Expanded Access Program

The Expanded Access Use of Vorasidenib in Patients With IDH1 or IDH2 Mutated Glioma or for Participants in Japan With Diffuse Glioma With IDH1 or IDH2 Mutations Who Have Undergone Surgery as Their Only Treatment

NCT05592743CI-TRIAL-00119278approved for marketingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This is an expanded access program to provide vorasidenib for treatment of patients 12 years or older with IDH1- or IDH2-mutated glioma. For participants in Japan, DIM-95032-001-JPN will provide access to vorasidenib for Japanese participants aged 12 years and older with IDH1- or IDH2-mutant diffuse glioma who have undergone surgery as their only treatment and have no immediate need for radiotherapy and/or chemotherapy. Participants will receive vorasidenib once daily as long as they continue to see a benefit, do not experience unacceptable reactions, and vorasidenib is not commercially available by prescription. Enrollment will continue until vorasidenib is commercially available in Japan or until the study closes. Participants will transition off the study within approximately 3 months after vorasidenib becomes commercially available by prescription with local reimbursement (price listing) in Japan. A final safety follow-up visit is conducted 30 days after the last dose of treatment on the study.

Conditions

Conditions (13)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Diffuse Glioma	Diffuse Glioma	ONTOLOGY_EXACT	0.98
Diffuse Glioma With IDH1 or IDH2 Mutations	—	UNRESOLVED	—
Disease Attributes	—	UNRESOLVED	—
Glioma	Glioma	ONTOLOGY_EXACT	0.98
Neoplasms	Neoplasm	ONTOLOGY_EXACT	0.90
Neoplasms by Histologic Type	—	UNRESOLVED	—
Neoplasms, Germ Cell and Embryonal	Neoplasm	ONTOLOGY_EXACT	0.85
Neoplasms, Glandular and Epithelial	Neoplasm	ONTOLOGY_EXACT	0.85

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Vorasidenib	Drug	Vorasidenib	ALIAS

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 12 Years

Show eligibility criteria text

Inclusion Criteria:

1. Male and females; ages ≥ 12 years old.
2. IDH-mutant oligodendroglioma or astrocytoma with the IDH1 or IDH2 gene mutation confirmed by tissue-based diagnosis.
3. At least 1 prior surgery for glioma (including biopsy).
4. Adequate bone marrow function as evidenced by:

   * Absolute neutrophil count ≥ 1.5 X 109/L
   * Hemoglobin ≥ 9 g/dL
   * Platelets ≥ 100 X 109/L
5. Adequate hepatic function as evidenced by:

   * Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN)
   * Aspartate aminotransferase and alanine aminotransferase: at or below the ULN
   * Alkaline phosphatase ≤ 2.5 X ULN
6. Adequate renal function as evidenced by a creatinine clearance (CrCl) ≥ 40 mL/min

   For participants in Japan, all the above inclusion criteria apply, as well as #7 and #8 below:
7. Have no immediate need of radiotherapy/chemotherapy as judged by the treating physician
8. Be able to understand and willing to sign informed consent/assent as determined by local requirements

   Exclusion criteria:
9. Patient is eligible for a clinical trial with vorasidenib.
10. Patients who are enrolled in a Servier-sponsored clinical trial and have completed all requirements of the trial may be eligible if the patient continues to benefit from vorasidenib and does not meet criteria for discontinuation of treatment.
11. Pregnant or breastfeeding.
12. Patients who require or who cannot withhold strong inhibitors of CYP1A2 (ciprofloxacin and fluvoxamine). Consider alternative therapies that are not strong CYP1A2 inhibitors.

    For participants in Japan, the above exclusion criteria do NOT apply. The applicable exclusion criteria for Japan are listed as #13 through #18 below:
13. Are participating in another investigational or interventional clinical trial
14. Have had any prior anticancer therapy other than surgery for treatment of glioma including systemic chemotherapy, radiotherapy, IDH inhibitors, and other anticancer therapies (investigational agents)
15. Are pregnant or breast feeding
16. Are men or women who will not agree to use highly effective forms of contraception during the trial
17. Have Grade 4 astrocytoma
18. Are taking strong CYP1A2 inhibitors like fluvoxamine maleate (Luvox, Depromel), etc

References

Publications (0)

Data not yet available

No reference posted for this study.