Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib Patients With m-CRPC
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- STATUS
- Recruiting
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- days left to enroll
- 54
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- participants needed
- 74
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- sponsor
- Laekna Limited
Summary
The combination treatment of protein kinase B (AKT) inhibitor, afuresertib, with androgen synthesis enzyme inhibitor, LAE001, may provide an effective treatment for metastatic castration resistant prostate cancer (m-CRPC) patients who have progressed/drug resistant following prior standard care treatments of any anti-androgen. This study intends to identify the most appropriate combined doses of LAE001/prednisone and afuresertib in m-CRPC patients who have progressive disease or are intolerant of 2 prior standard treatments of any anti-androgen or anti-androgen treatment plus chemotherapy.
Description
The Phase I part of this study will perform a dose-escalation to identify the recommended Phase II dose of LAE001/prednisone plus afuresertib in m-CRPC patients.
In the Phase II part of this study, the anti-tumor efficacy of LAE001/prednisone plus afuresertib and docetaxel/prednisone plus afuresertib will be assessed in mCRPC patients with PTEN loss and/or PIK3CA/AKT/PTEN alteration who have progressed on, or who are intolerant of, 1-3 prior standard treatments for mCSPC, or nmCRPC, or mCRPC, including at least one antiandrogen treatment and no more than one chemotherapy. Participants will be assigned to one of the two study cohorts, based on the investigator's clinical judgement. Cohort 1 will receive LAE001/prednisone plus afuresertib using RP2D established in the Phase I study. Cohort 2 will receive docetaxel/prednisone plus afuresertib, with a safety run-in period during the first cycle in the first 6 patients. These study results will provide preliminary efficacy and safety information of the combination of LAE001/prednisone plus afuresertib and docetaxel/prednisone plus afuresertib as requested in the Food and Drug Administration (FDA) combined therapy guideline. Whether to move one or both combination therapies to the pivotal study will be based on the PFS improvements of the combination therapy versus historical controls of abiraterone or docetaxel monotherapies in mCRPC patients who failed 1-3 lines of standard of care therapies.
Details
| Condition | Metastatic Castration-resistant Prostate Cancer |
|---|---|
| Treatment | Phase I and Phase II: LAE001/prednisone + afuresertib |
| Clinical Study Identifier | NCT04060394 |
| Sponsor | Laekna Limited |
| Last Modified on | 10 August 2022 |
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