Clinical trial · Interventional
Open Study of CEP-701 in Patients With Refractory Acute Myeloid Leukemia With FLT-3 Mutation
An Open-Label Study of CEP-701 in Patients With Refractory, Relapsed, or Poor Risk Acute Myeloid Leukemia Expressing FLT-3 Activating Mutations
NCT00030186CI-TRIAL-00007872completedPhase 2ClinicalTrials.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 determine the response rate of patients with refractory, relapsed or poor risk AML expressing FLT-3 activating mutations, when administered CEP-701 at a dosage of 60 mg 2 times a day.
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 |
|---|---|---|---|
| Leukemia, Myeloid | Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cep-701 40mg | Drug | — | UNRESOLVED |
| CEP-701 60mg | Drug | — | UNRESOLVED |
| Cep-701 80mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cycle 1
- description
- 60mg
- interventionNames
- Drug: CEP-701 60mg
- type
- EXPERIMENTAL
- label
- Cycle 2
- description
- 80mg dependent upon response to Cycle 1
- interventionNames
- Drug: Cep-701 80mg
- type
- EXPERIMENTAL
- label
- Cycle 2b
- description
- 40mg dependent upon response to Cycle 1
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA: * patient must have confirmed diagnosis of refractory or relapsed AML that expresses a FLT-3 mutation * patient must have life expectancy of more than 2 months * patient must be fully recovered from reversible side effects of previous therapy for cancer EXCLUSION CRITERIA: * total bilirubin, ALT or AST greater than 2 times upper limit of normal * patient \<65 years of age with estimated creatinine clearance less than 60 mL/min; patient \>65 years of age with serum creatinine \> 1.5 times the upper limit of normal (ULN) * received any investigational drug within past 4 weeks * GI disturbance/malabsorption that may affect absorption of CEP-701 * HIV positive * received NSAID within prior 14 days * has active infection
References
Publications (0)
Data not yet available
No reference posted for this study.