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NCT Number: NCT02381886

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced Malignancies That Harbor IDHR132 Mutations Adenocarcinoma Astrocytoma Bone Marrow Diseases Carcinoma Cholangiocarcinoma Glioblastoma Glioma Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Oligodendroglioma

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Melbourne, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IDH305

Drug

Primary outcomes

  1. Incident rate of dose limiting toxicities (DLTs)

    Time frame: 21 days

    To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE)

Secondary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: 30 months

    To characterize the safety and tolerability of IDH305

  2. Plasma PK parameters (AUC, Cmax, Tmax)

    Time frame: 30 months

    To characterize the PK profile of IDH305

  3. Changes of 2-hydroxyglutarate concentration in patient specimens

    Time frame: 30 months

    To characterize the PD profile of IDH305

  4. Overall response rate (ORR)

    Time frame: 30 months

    To assess any preliminary anti-tumor activity of IDH305

  5. Incidence of serious adverse events (SAE)

    Time frame: 30 months

    To characterize the safety and tolerability of IDH305

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2030
First posted
Mar 6, 2015
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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