Approval Probability
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Also known as lestaurtinib
CEP-701 · 5 trials · 6 indications
The primary objective of the study is to evaluate the efficacy of oral escalating dosages of CEP-701 at 20, 40, 60, and 80 mg given twice daily (bid) in achieving complete or nearly clearing of psoriasis in patients with severe, recalcitrant, plaque-type psoriasis, as assessed by the Physicians Static Global (PSGA) at baseline and at the end of treatment. A PSGA score of 0 is defined as no evidence of plaque elevation, no evidence of erythema, and no evidence of scaling. A PSGA score of 5 is defined as plaque elevation (2.5 mm or greater)dusky to deep red coloration, very thick tenacious scale predominates.
Response rate of patients with refactory, relapsed, or poor risk acute myeloid leukemia (AML) expressing Fms-like tyrosine kinase 3 (FLT-3) activating mutations. CR is defined as presence of less than 5% myeloblasts in bone marrow with normalized peripheral blood cell counts. HR is defined as a 50% or more decrease in the absolute number of peripheral blast count or at least a 50% reduction in bone marrow blasts.
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | Induction chemotherapy with or without sequential treatment with oral CEP-701 at 80 mg bid. For patients with duration of first CR of 1 to 6 months, the induction regimen will be MEC. |
| 2 | ACTIVE_COMPARATOR | Induction chemotherapy with or without sequential treatment with oral CEP-701 at 80 mg bid. For patients with duration of first CR of more than 6 months to 24 months, the induction regimen will be HiDAC. |
| CEP-701 20mg | EXPERIMENTAL | Patient Cohort 1 |
| CEP-701 40mg | EXPERIMENTAL | Patient Cohort 2 |
| CEP-701 60mg | EXPERIMENTAL | Patient Cohort 3 |
| CEP-701 80mg | EXPERIMENTAL | Patient Cohort 4 |
| Cycle 1 | EXPERIMENTAL | 60mg |
| Cycle 2 | EXPERIMENTAL | 80mg dependent upon response to Cycle 1 |
| Cycle 2b | EXPERIMENTAL | 40mg dependent upon response to Cycle 1 |
| lestaurtinib | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CEP-701 | DRUG | - |
| high-dose cytarabine | DRUG | Chemotherapy |
| Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy) | DRUG | Chemotherapy |
| CEP-701 20mg | DRUG | Dosages of oral CEP-701 20mg will be given twice daily. Escalation to the next higher dosage, CEP-701 40mg, may occur once the first 8 patients at the current dosage have completed 8 weeks of treatment without adverse events or laboratory abnormalities. Patients who remain in Cohort 1 will continue on the 20mg dosage until study completion. |
| CEP-701 40mg | DRUG | Dosages of oral CEP-701 40mg will be given twice daily.Escalation to the next higher dosage, CEP-701 60mg, may occur once 8 weeks of treatment at the current dosage is completed without adverse events or laboratory abnormalities. Patients who remain in Cohort 2 will continue on the 40mg dosage until study completion. |
| CEP-701 60mg | DRUG | Dosages of oral CEP-701 60mg will be given twice daily. Escalation to the next higher dosage, CEP-701 80mg, may occur once 8 weeks of treatment at the current dosage is completed without adverse events or laboratory abnormalities. Patients who remain in Cohort 3 will continue on the 60mg dosage until study completion. |
| CEP-701 80mg | DRUG | Dosages of oral CEP-701 80mg will be given twice daily. Patients who have moved to Cohort 4 will continue on the 80mg dosage until study completion. |
| lestaurtinib | DRUG | 60 mg bid - 120 mg bid for an 18 weeks (126 days) treatment duration |
Inclusion criteria: * cytological confirmation of AML; * relapsed disease following first CR of 1 month(30days)to 24 months(730days). The time from first relapse to study entry (start of first course of induction chemotherapy) must be no longer than 30days; * confirmation of FLT-3 activating mutati...
CEP-701 is an investigational small molecule drug developed by Teva Pharmaceutical Industries Limited (ticker: TEVA). It has been studied in Phase 2 clinical trials for several conditions, including acute myeloid leukemia, other myeloid leukemias, prostate cancer, and psoriasis. It is not approved for any indication and remains in clinical development.
CEP-701 has been studied in clinical trials for acute myeloid leukemia, leukemia, myeloid, prostate cancer, and psoriasis. These studies were Phase 2 and have been completed. CEP-701 is not approved for any use; it is an investigational agent that has been tested in these disease areas.
CEP-701 is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical trials evaluating CEP-701 in conditions such as acute myeloid leukemia, prostate cancer, and psoriasis.
CEP-701 is in Phase 2 development. All of its clinical trials to date have been Phase 2 studies, and these trials have been completed. There are no active trials currently listed for CEP-701. It is an investigational drug and has not been approved by the FDA for any indication.
CEP-701 has been evaluated in completed Phase 2 trials, including NCT00236119 in severe psoriasis, NCT00081601 in prostate cancer, NCT00079482 in acute myeloid leukemia, and NCT00030186 in refractory acute myeloid leukemia with FLT-3 mutation. These trials enrolled patients across multiple countries and are no longer recruiting.