Trial of IDH305 in IDH1 Mutant Grade II or III Glioma (NCT02977689) | Clinical Trial Compass
WithdrawnPhase 2
Trial of IDH305 in IDH1 Mutant Grade II or III Glioma
Stopped: Novartis paused all study start-up activities due to safety evaluation of IDH305 compound.
United States0Started 2018-04
Plain-language summary
The purpose of this study is to found out if the drug IDH305 is safe and effective in subjects with IDH1 mutant grade II or III glioma that has progressed after observation or radiation therapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements.
✓. Subject must be ≥18 years of age.
✓. Patients must have written documentation of IDH1 mutation at the R132 locus by immunohistochemistry or DNA sequencing in their tumor.
✓. Histopathological diagnosis of a glioma of WHO grade II or III at initial diagnosis. Documentation of diagnosis by pathology report is sufficient for eligibility.
✓. First line management with observation alone or external beam radiation after surgery. Notes or records from the treating oncologist or radiation oncologist are required for documentation of treatment history.
✓. Patients must have unequivocal progression on brain MRI after observation or external beam radiation. If a patient was initially diagnosed with a non-enhancing tumor and the tumor develops new contrast-enhancement at progression, they will be excluded except for the following exceptions:
✓. Patients with tumors that were contrast-enhancing at initial diagnosis of grade II or III glioma will be allowed if their tumors are contrast-enhancing at progression as well.
✓. If a patient with a grade II or III glioma has a tumor that develops new contrast-enhancement at progression, the enhancing portion of the progressive tumor must be biopsy proven WHO grade II or III at progression.
Exclusion criteria
✕. Glioblastoma (WHO grade IV) histopathology on any tumor sample
✕. Unable to tolerate a contrast-enhanced brain MRI or if MRI is contraindicated
✕. Two weeks since any major surgery treatment (mediastinoscopy, insertion of a central venous access device and insertion of a feeding tube are not considered major surgery) prior to registration, with the exception of stereotactic biopsy for glioma, in which case an interval of 1 week until registration is allowed.
✕. Patients who are currently receiving treatment with a prohibited medication or herbal remedy that cannot be discontinued at least one week prior to the start of treatment.
✕. Narrow therapeutic index substrates of CYP3A, CYP2C9, CYP2C19, and CYP2C8
✕. Medications, herbs and supplements that are strong inhibitors and strong inducers of CYP3A