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

Running, not enrolling · Phase 1

Conditions studied: Advanced Malignancies That Harbor IDHR132 Mutations

In brief

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

Key facts

Study ID

NCT02381886

Run by

Novartis Pharmaceuticals

People needed

166

Starts

2015-03-06

Expected to finish

2030-10-31

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Dana Farber Cancer Institute SC (1) — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Columbia University Medical Center- New York Presbyterian Onc Dept. — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Uni Of TX MD Anderson Cancer Cntr — Houston, Texas, United States
• Novartis Investigative Site — Melbourne, Victoria, Australia
• Novartis Investigative Site — Parkville, Victoria, Australia
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Cologne, North Rhine-Westphalia, Germany
• Novartis Investigative Site — Jena, Thuringia, Germany
• Novartis Investigative Site — Heidelberg, Germany
• Novartis Investigative Site — Rotterdam, South Holland, Netherlands
• ErasmusMC Cancer lnstitute, Neuro-Oncology, Rm G3-55 — Rotterdam, Netherlands
• Novartis Investigative Site — Singapore, Singapore
• Novartis Investigative Site — Barcelona, Spain

Full record on ClinicalTrials.gov

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