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

Novartis Pharmaceuticals

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Acute Myeloid Leukemia (AML)

Interventions

IDH305DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Dose Limiting toxicities

(escalation only)

Time frame: 10 months

Number of patients with adverse events (AEs)

Time frame: 36 months

Secondary Outcomes

Area Under Curve (AUC)

To characterize the PK profile of IDH305 with SOC medications (each Arm)

Time frame: 36 months

Maximum Plasma Concentration (Cmax)

To characterize the PK profile of IDH305 with SOC medications (each Arm)

Time frame: 36 months

Time taken to reach maximum plasma concentration (Tmax)

To characterize the PK profile of IDH305 with SOC medications (each Arm)

Time frame: 36 months

Complete remission rate (CRR)

To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2)

Time frame: 36 months

Overall response rate (ORR)

To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2)

Time frame: 36 months

Event free survival (EFS)

To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2)

Time frame: 36 months

Data from ClinicalTrials.gov

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