A Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia

Novartis

Status and phase: Withdrawn; Phase 1

Conditions: Acute Myeloid Leukemia (AML)

Treatments: Drug: IDH305

Study type: Interventional

Funder types: Industry

Identifiers

NCT02826642

CIDH305X2102

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability and potential efficacy of IDH305 with standard treatments for newly diagnosed IDH1R132 mutant acute myeloid leukemia (AML).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-- Previously untreated AML. Patients with untreated, high or very high risk MDS (according to rIPSS or equivalent) are also permitted in Arm 2.

• Documentation of IDH1R132 mutation of tumor
• ECOG performance status ≤ 2
• Clinically fit for standard of care medication per protocol.

Exclusion criteria

• Prior treatment for AML or MDS
• Any severe or uncontrolled 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: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Arm 1: Medically fit for induction

Experimental group

Description:

IDH305 + Standard of care for patients that are medically fit for induction.

Treatment:

Drug: IDH305

Arm 2 Medically unfit for induction

Experimental group

Description:

IDH305 + Standard of care for patients that are medically unfit for induction.

Treatment:

Drug: IDH305