Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CEP-701
lestaurtinib · 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...
Top 6 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Bomedemstat |
| Protagonist Therapeutics, Inc. | PTGX | 2 | PHASE3 | Rusfertide |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-3405 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 3 | PHASE2 | Rusfertide |
| Agios Pharmaceuticals, Inc. | AGIO | 1 | PHASE2 | AG-236 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
Lestaurtinib is an investigational small molecule being studied for polycythemia vera, a myeloproliferative blood disorder. It has also been evaluated in essential thrombocytosis. It is not approved for any indication and remains in clinical development.
Lestaurtinib is an inhibitor of NTRK1, NTRK2, NTRK3, FLT3, JAK2, and RET. By blocking these kinases, it aims to interfere with signaling pathways that drive abnormal blood cell production in myeloproliferative neoplasms such as polycythemia vera.
Lestaurtinib is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company holds the asset as part of its hematology pipeline.
Lestaurtinib is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA for any indication.
Lestaurtinib has been studied in one completed Phase 2 trial, NCT00586651, an open-label study in patients with polycythemia vera or essential thrombocytosis. The trial enrolled 39 participants in the United States and is now completed.
Yes, the lestaurtinib Phase 2 trial NCT00586651 was biomarker selected, meaning participants were chosen based on specific biological markers. The study was open label, uncontrolled, and enrolled 39 adults with polycythemia vera or essential thrombocytosis.