We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02381886
First Posted: March 6, 2015
Last Update Posted: August 2, 2017
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132 mutations.

Condition Intervention Phase
Advanced Malignancies That Harbor IDHR132 Mutations Drug: IDH305 Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Incident rate of dose limiting toxicities (DLTs) [ Time Frame: 9 months ]
    To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE)


Secondary Outcome Measures:
  • Incidence of adverse events (AEs) [ Time Frame: 30 months ]
    To characterize the safety and tolerability of IDH305

  • Plasma PK parameters (AUC, Cmax, Tmax) [ Time Frame: 30 months ]
    To characterize the PK profile of IDH305

  • Changes of 2-hydroxyglutarate concentration in patient specimens [ Time Frame: 30 months ]
    To characterize the PD profile of IDH305

  • Overall response rate (ORR) [ Time Frame: 30 months ]
    To assess any preliminary anti-tumor activity of IDH305

  • Incidence of serious adverse events (SAE) [ Time Frame: 30 months ]
    To characterize the safety and tolerability of IDH305


Estimated Enrollment: 180
Actual Study Start Date: March 6, 2015
Estimated Study Completion Date: December 26, 2018
Estimated Primary Completion Date: February 2, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDH305 Drug: IDH305

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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
University of Texas/MD Anderson Cancer Center Dept. of Onc.
Houston, Texas, United States, 77030-4009
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
Koeln, Nordrhein-Westfalen, Germany, 50937
Novartis Investigative Site
Heidelberg, Germany, 69120
Novartis Investigative Site
Jena, Germany, 07740
Netherlands
VU Medical Center - Hematology
Amsterdam, Netherlands, 1081 HV
ErasmusMC Cancer lnstitute, Neuro-Oncology, Rm G3-55
Rotterdam, Netherlands, 3075 EA
Singapore
Novartis Investigative Site
Singapore, Singapore, 169610
Spain
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02381886     History of Changes
Other Study ID Numbers: CIDH305X2101
First Submitted: March 2, 2015
First Posted: March 6, 2015
Last Update Posted: August 2, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Neoplasms