A Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia

• Status: Withdrawn
• Trial end date: 2016-11-29
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability and potential efficacy of IDH305 with standard treatments for newly diagnosed IDH1R132 mutant acute myeloid leukemia (AML).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

-- Previously untreated AML. Patients with untreated, high or very high risk MDS (according to rIPSS or equivalent) are also permitted in Arm 2.

• Documentation of IDH1R132 mutation of tumor

• ECOG performance status ≤ 2

• Clinically fit for standard of care medication per protocol.

Exclusion Criteria:

• Prior treatment for AML or MDS

• Any severe or uncontrolled medical conditions that would prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures such as the presence of other clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological disease.

• Acute Promyelocytic Leukemia

• Women who are pregnant or lactating

Other protocol-defined Inclusion/Exclusion may apply