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Clinical Trials in Spain / NCT02381886
Active, not recruiting Phase 1

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

NCT02381886 · tracked via the Priya Life Science Spain 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
No
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)

FacilityCityRegionStatus
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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A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS) Active, not recruiting
Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer Active, not recruiting
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 Spain