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

A Phase I, Open Label, Multicenter, Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02826642

Enrollment

Registered

2016-07-11

Start date

2016-08-26

Completion date

2016-11-29

Last updated

2019-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia (AML)

Keywords

newly diagnosed acute myeloid leukemia, AML, myeloid dysplastic syndrome, MDS, IDH305, standard of care in IDH1 mutant acute myeloid leukemia

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).

Interventions

DRUGIDH305

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Dose Limiting toxicities	10 months	(escalation only)
Number of patients with adverse events (AEs)	36 months	—

Secondary

Measure	Time frame	Description
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)
Area Under Curve (AUC)	36 months	To characterize the PK profile of IDH305 with SOC medications (each Arm)
Event free survival (EFS)	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)
Maximum Plasma Concentration (Cmax)	36 months	To characterize the PK profile of IDH305 with SOC medications (each Arm)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026