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

Phase 1

Withdrawn

• Conditions: Acute Myeloid Leukemia (AML)
• Interventions: Drug: IDH305

• Registration Number: NCT02826642
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-13
• Study First Submitted QC: 2016-07-05
• Study First Posted: 2016-07-11
• Study Start: 2016-08-26
• Primary Completion: 2016-11-29
• Study Completion: 2016-11-29
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-08
• Last Update Posted: 2019-04-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Medically fit for induction	IDH305	IDH305 + Standard of care for patients that are medically fit for induction.
Arm 2 Medically unfit for induction	IDH305	IDH305 + Standard of care for patients that are medically unfit for induction.

Primary Outcome Measures

Name	Time	Method
Dose Limiting toxicities	10 months	(escalation only)
Number of patients with adverse events (AEs)	36 months

Secondary Outcome Measures

Name	Time	Method
Area Under Curve (AUC)	36 months	To characterize the PK profile of IDH305 with SOC medications (each Arm)
Maximum Plasma Concentration (Cmax)	36 months	To characterize the PK profile of IDH305 with SOC medications (each Arm)
Time taken to reach maximum plasma concentration (Tmax)	36 months	To characterize the PK profile of IDH305 with SOC medications (each Arm)
Complete remission rate (CRR)	36 months	To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2)
Overall response rate (ORR)	36 months	To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2)
Event free survival (EFS)	36 months	To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2)