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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02381886
Recruitment Status : Active, not recruiting
First Posted : March 6, 2015
Last Update Posted : February 28, 2024
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132 mutations.

Condition or disease Intervention/treatment Phase
Advanced Malignancies That Harbor IDHR132 Mutations Drug: IDH305 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations
Actual Study Start Date : January 6, 2015
Actual Primary Completion Date : December 7, 2016
Estimated Study Completion Date : October 24, 2025

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Arms and Interventions
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Arm Intervention/treatment
Experimental: IDH305 Drug: IDH305


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02381886


Locations
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United States, Massachusetts
Dana Farber Cancer Institute SC (1)
Boston, Massachusetts, United States, 02115
United States, New York
Columbia University Medical Center- New York Presbyterian Onc Dept.
New York, New York, United States, 10032
United States, Texas
Uni of TX MD Anderson Cancer Cntr .
Houston, Texas, United States, 77030
Australia, Victoria
Novartis Investigative Site
Melbourne, Victoria, Australia, 3004
Novartis Investigative Site
Parkville, Victoria, Australia, 3050
Belgium
Novartis Investigative Site
Leuven, Belgium, 3000
Canada, Ontario
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2M9
Germany
Novartis Investigative Site
Heidelberg, Germany, 69120
Novartis Investigative Site
Jena, Germany, 07740
Novartis Investigative Site
Koeln, Germany, 50937
Netherlands
ErasmusMC Cancer lnstitute, Neuro-Oncology, Rm G3-55
Rotterdam, Netherlands, 3075 EA
Singapore
Novartis Investigative Site
Singapore, Singapore, 168583
Spain
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02381886    
Other Study ID Numbers: CIDH305X2101
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: February 28, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
IDHR132 mutations
IDH305
IDH
IDH1
AML
Acute Myeloid Leukemia
Leukemia
Myeloid
Acute
 MDS
Myelodysplastic Syndrome
Glioma
Oligodendroglioma
Astrocytoma
Glioblastoma
Cholangiocarcinoma
Solid Tumors
Additional relevant MeSH terms:
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Neoplasms