Clinical trial · Interventional
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
NCT02826642CI-TRIAL-00038043withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IDH305 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: Medically fit for induction
- description
- IDH305 + Standard of care for patients that are medically fit for induction.
- interventionNames
- Drug: IDH305
- type
- EXPERIMENTAL
- label
- Arm 2 Medically unfit for induction
- description
- IDH305 + Standard of care for patients that are medically unfit for induction.
- interventionNames
- Drug: IDH305
Primary outcomes (2)
- measure
- Dose Limiting toxicities
- timeFrame
- 10 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.