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

Novartis

Status and phase: Active, not recruiting; Phase 1

Conditions: Advanced Malignancies That Harbor IDHR132 Mutations

Treatments: Drug: IDH305

Study type: Interventional

Funder types: Industry

Identifiers

NCT02381886

CIDH305X2101

Details and patient eligibility

About

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

Enrollment: 166 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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166 participants in 1 patient group

IDH305

Experimental group

Treatment:

Drug: IDH305