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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02381886
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Novartis Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Novartis Pharmaceuticals
Principal Investigator Affiliation Novartis Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Australia, Belgium, Canada, Germany, Netherlands, Singapore, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Advanced Malignancies That Harbor IDHR132 Mutations
Arms & Interventions

Arms

Experimental: IDH305

Interventions

Drug: - IDH305

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dana Farber Cancer Institute SC (1), Boston, Massachusetts

Status

Address

Dana Farber Cancer Institute SC (1)

Boston, Massachusetts, 02115

New York, New York

Status

Address

Columbia University Medical Center- New York Presbyterian Onc Dept.

New York, New York, 10032

Uni Of TX MD Anderson Cancer Cntr, Houston, Texas

Status

Address

Uni Of TX MD Anderson Cancer Cntr

Houston, Texas, 77030

International Sites

Novartis Investigative Site, Melbourne, Victoria, Australia

Status

Address

Novartis Investigative Site

Melbourne, Victoria, 3004

Novartis Investigative Site, Parkville, Victoria, Australia

Status

Address

Novartis Investigative Site

Parkville, Victoria, 3050

Novartis Investigative Site, Leuven, Belgium

Status

Address

Novartis Investigative Site

Leuven, , 3000

Novartis Investigative Site, Toronto, Ontario, Canada

Status

Address

Novartis Investigative Site

Toronto, Ontario, M5G 2M9

Novartis Investigative Site, Heidelberg, Germany

Status

Address

Novartis Investigative Site

Heidelberg, , 69120

Novartis Investigative Site, Jena, Germany

Status

Address

Novartis Investigative Site

Jena, , 07740

Novartis Investigative Site, Koeln, Germany

Status

Address

Novartis Investigative Site

Koeln, , 50937

Rotterdam, Netherlands

Status

Address

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

Rotterdam, , 3075 EA

Novartis Investigative Site, Singapore, Singapore

Status

Address

Novartis Investigative Site

Singapore, , 168583

Novartis Investigative Site, Barcelona, Catalunya, Spain

Status

Address

Novartis Investigative Site

Barcelona, Catalunya, 08035