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

NCT ID: NCT02381886

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-06

Study Completion Date

2027-02-10

Brief Summary

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

Detailed Description

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Conditions

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Advanced Malignancies That Harbor IDHR132 Mutations

Keywords

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IDHR132 mutations IDH305 IDH IDH1 AML Acute Myeloid Leukemia Leukemia Myeloid Acute MDS Myelodysplastic Syndrome Glioma Oligodendroglioma Astrocytoma Glioblastoma Cholangiocarcinoma Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IDH305

Group Type EXPERIMENTAL

IDH305

Intervention Type DRUG

Interventions

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IDH305

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Dana Farber Cancer Institute SC (1)

Boston, Massachusetts, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Columbia University Medical Center- New York Presbyterian Onc Dept.

New York, New York, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Uni Of TX MD Anderson Cancer Cntr

Houston, Texas, United States

Site Status

Novartis Investigative Site

Melbourne, Victoria, Australia

Site Status

Novartis Investigative Site

Parkville, Victoria, Australia

Site Status

Novartis Investigative Site

Leuven, , Belgium

Site Status

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany

Site Status

Novartis Investigative Site

Jena, Thuringia, Germany

Site Status

Novartis Investigative Site

Heidelberg, , Germany

Site Status

Novartis Investigative Site

Rotterdam, South Holland, Netherlands

Site Status

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

Rotterdam, , Netherlands

Site Status

Novartis Investigative Site

Singapore, , Singapore

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status

Countries

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United States Australia Belgium Canada Germany Netherlands Singapore Spain

References

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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.

Reference Type DERIVED
PMID: 35353219 (View on PubMed)

Other Identifiers

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CIDH305X2101

Identifier Type: -

Identifier Source: org_study_id