NCT02381886

Brief Summary

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

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for phase_1

Timeline
54mo left

Started Mar 2015

Longer than P75 for phase_1

Geographic Reach
8 countries

16 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Mar 2015Oct 2030

First Submitted

Initial submission to the registry

March 2, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

March 6, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2016

Completed
13.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2030

Expected
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

March 2, 2015

Last Update Submit

April 8, 2026

Conditions

Advanced Malignancies That Harbor IDHR132 Mutations

Keywords

IDHR132 mutationsIDH305IDHIDH1AMLAcute Myeloid LeukemiaLeukemiaMyeloidAcuteMDSMyelodysplastic SyndromeGliomaOligodendrogliomaAstrocytomaGlioblastomaCholangiocarcinomaSolid Tumors

Outcome Measures

Primary Outcomes (1)

  • Incident rate of dose limiting toxicities (DLTs)

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

    21 days

Secondary Outcomes (5)

  • Incidence of adverse events (AEs)

    30 months

  • Plasma PK parameters (AUC, Cmax, Tmax)

    30 months

  • Changes of 2-hydroxyglutarate concentration in patient specimens

    30 months

  • Overall response rate (ORR)

    30 months

  • Incidence of serious adverse events (SAE)

    30 months

Study Arms (1)

IDH305

EXPERIMENTAL
Drug: IDH305

Interventions

IDH305DRUG
IDH305

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Dana Farber Cancer Institute SC (1)

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Columbia University Medical Center- New York Presbyterian Onc Dept.

New York, New York, 10032, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Uni Of TX MD Anderson Cancer Cntr

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

Melbourne, Victoria, 3004, Australia

Location

Novartis Investigative Site

Parkville, Victoria, 3050, Australia

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Toronto, Ontario, M5G 2M9, Canada

Location

Novartis Investigative Site

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Novartis Investigative Site

Jena, Thuringia, 07740, Germany

Location

Novartis Investigative Site

Heidelberg, 69120, Germany

Location

Novartis Investigative Site

Rotterdam, South Holland, 3015 GD, Netherlands

Location

ErasmusMC Cancer lnstitute, Neuro-Oncology, Rm G3-55

Rotterdam, 3075 EA, Netherlands

Location

Novartis Investigative Site

Singapore, 168583, Singapore

Location

Novartis Investigative Site

Barcelona, 08035, Spain

Location

Related Publications (1)

  • DiNardo CD, Hochhaus A, Frattini MG, Yee K, Zander T, Kramer A, Chen X, Ji Y, Parikh NS, Choi J, Wei AH. A phase 1 study of IDH305 in patients with IDH1R132-mutant acute myeloid leukemia or myelodysplastic syndrome. J Cancer Res Clin Oncol. 2023 Mar;149(3):1145-1158. doi: 10.1007/s00432-022-03983-6. Epub 2022 Mar 30.

    PMID: 35353219DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteLeukemiaMyelodysplastic SyndromesGliomaOligodendrogliomaAstrocytomaGlioblastomaCholangiocarcinoma

Condition Hierarchy (Ancestors)

Leukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueAdenocarcinomaCarcinoma

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 6, 2015

Study Start

March 6, 2015

Primary Completion

December 7, 2016

Study Completion (Estimated)

October 31, 2030

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

AU(2)ES(1)CA(1)DE(3)US(5)BE(1)NL(2)SG(1)