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

ClinicalTrials.gov Identifier: NCT02381886

Novartis Reference Number: CIDH305X2101

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Advanced Malignancies That Harbor IDHR132 Mutations
Phase 
Phase 1
Overall status 
Active, not recruiting
Enrollment count 
166 participants
Start date 
Mar 06, 2015
Completion date 
Jun 11, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
IDH305

Eligibility 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

Study Locations

United States
Dana Farber Cancer Institute SC (1)
-
Boston, 02115
Massachusetts
United States
Columbia University Medical Center- New York Presbyterian Onc Dept.
-
New York, 10032
New York
United States
University of Texas MD Anderson Cancer Center
-
Houston, 77030
Texas
United States
Australia
Novartis Investigative Site
-
Melbourne, 3004
Victoria
Australia
Novartis Investigative Site
-
Parkville, 3050
Victoria
Australia
Belgium
Novartis Investigative Site
-
Leuven, 3000
-
Belgium
Canada
Novartis Investigative Site
-
Toronto, M5G 2M9
Ontario
Canada
Germany
Novartis Investigative Site
-
Koeln, 50937
Nordrhein-Westfalen
Germany
Novartis Investigative Site
-
Heidelberg, 69120
-
Germany
Novartis Investigative Site
-
Jena, 07740
-
Germany
Netherlands
VU Medical Center - Hematology
-
Amsterdam, 1081 HV
-
Netherlands
ErasmusMC Cancer lnstitute, Neuro-Oncology, Rm G3-55
-
Rotterdam, 3075 EA
-
Netherlands
Singapore
Novartis Investigative Site
-
Singapore, 169610
-
Singapore
Spain
Novartis Investigative Site
-
Barcelona, 08035
Catalunya
Spain

Have a question?

Call 1-999-669-6682 or email [email protected]