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CEP-701 · 4 trials · 4 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 |
|---|---|---|
| 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 |
| 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. |
| Cycle 1 | EXPERIMENTAL | 60mg |
| Cycle 2 | EXPERIMENTAL | 80mg dependent upon response to Cycle 1 |
| Cycle 2b | EXPERIMENTAL | 40mg dependent upon response to Cycle 1 |
| Name | Type | Description |
|---|---|---|
| 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. |
| CEP-701 | DRUG | - |
| high-dose cytarabine | DRUG | Chemotherapy |
| Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy) | DRUG | Chemotherapy |
Inclusion Criteria: Patients are included in the study if all of the following criteria are met: * the patient is at least 21 years old. * The patient has sever, recalcitrant, plaque-type psoriasis and has failed at least 1 systemic therapy (for the purposes of this study psoralen with ultraviolet...
CEP-701 is an investigational small molecule being studied for acute myeloid leukemia, psoriasis, prostate cancer, and myeloid leukemia. It is in Phase 2 clinical development and has not been approved by the FDA.
CEP-701 is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The drug is an investigational small molecule in Phase 2 clinical trials.
CEP-701 is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. Clinical trials for the drug have been completed across multiple indications.
CEP-701 has completed Phase 2 trials including NCT00030186 for refractory acute myeloid leukemia with FLT-3 mutation, NCT00079482 for acute myeloid leukemia, NCT00081601 for prostate cancer, and NCT00236119 for severe psoriasis.
Yes, CEP-701 is also known as lestaurtinib. One clinical trial, NCT00079482, refers to the drug as CEP-701 (Lestaurtinib) in patients with acute myeloid leukemia.