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A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations

NCT02381886

Active Not RecruitingPhase 1

Sponsor: Novartis Pharmaceuticals

Conditions: Advanced Malignancies That Harbor IDHR132 Mutations

Interventions: IDH305

Countries: United States, Australia, Belgium, Canada, Germany, Netherlands, Singapore, Spain

A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132 mutations.

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Documented IDH1R132-mutant tumors
* ECOG performance status ≤ 2

Exclusion Criteria:

* Patients who have received prior treatment with a mutant-specific IDH1 inhibitor (with the exception of glioma patients)
* 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

Locations (16)

Boston, Massachusetts, United States
Boston, Massachusetts, United States
New York, New York, United States
New York, New York, United States
Houston, Texas, United States
Melbourne, Victoria, Australia
Parkville, Victoria, Australia
Leuven, Belgium
Toronto, Ontario, Canada
Cologne, North Rhine-Westphalia, Germany
Jena, Thuringia, Germany
Heidelberg, Germany
Rotterdam, South Holland, Netherlands
Rotterdam, Netherlands
Singapore, Singapore
Barcelona, Spain