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

NCT02381886 · tracked via the Priya Life Science USA tracker

Sponsor

Novartis Pharmaceuticals

Phase

Phase 1

Started

2015-03-06

Last updated

2026-04-13

Condition(s) studied

Advanced Malignancies That Harbor IDHR132 Mutations

Investigational drug(s) / intervention(s)

IDH305

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

100 Years

Healthy volunteers

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

Primary outcome measure(s)

Incident rate of dose limiting toxicities (DLTs) — 21 days
To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE)

Trial sites (16)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02381886 on ClinicalTrials.gov ↗ ← All trials in the USA