A Phase I Study of IDH305 in Patients with Advanced Malignancies that Harbor IDH1R132 Mutations

Study Name: A Phase I Study of IDH305 in Patients with Advanced Malignancies that Harbor IDH1R132 Mutations

ClinicalTrials.gov Identifier (if applicable): NCT02381886

Institution Name: MD Anderson Cancer Center

Institution Address: 1515 Holcombe Blvd, Unit 426, Houston, TX 77030

Phone: (713)563-1193

Principal Investigator: FILIP JANKU, MD, (713)563-1193, vstepane@mdanderson.org

Milind Javle, MD. Email: mjavle@mdanderson.org; 713-792-2828

Study Coordinator: Vanda Stepanek, (713)563-1193, vstepane@mdanderson.org

Overview: This study will enroll patients with cholangiocarcinoma, acute myeloid leukemia and glioma having IDH1R132 mutation in a clinical trial with the IDH1 inhibitor IDH305. Patients must have received one prior chemotherapy and demonstrated progression after the same. The phase I study will be followed by study expansions in cholangiocarcinoma.

Enrollment: 140

Study Start Date: 3/2/15

Estimated Completion Date: 11/1/17

Purpose of the Study – in Layman’s Terms: To examine toxicity, efficacy of the study agent

Inclusion Criteria – Patients Must: IDH1132 mutation. Good performance status, Tumor progressed from prior chemotherapy|

Exclusion Criteria – Patients Must NOT: Jaundice, pregnancy or lactation, prior IDH1 inhibitor

Required Tests Prior to Beginning Study Treatment: CT scans, biochemical tests for liver and kidney and complete blood counts

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