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Also known as Mervometostat (PF-06821497), Mervometostat, Mevrometostat
PF-06821497 · 3 trials · 3 indications
rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or in bone per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines by BICR, or death, whichever occurs first.
rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or in bone per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines by BICR, or death, whichever occurs first.
To characterize the extent of excretion of total radioactivity in urine and feces following administration of a single oral dose of \[14C\]PF-06821497
Amount of metabolites of \[14C\]PF-06821497 in plasma, urine, and feces
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Participants will receive PF-06821497 (875 mg) BID (twice daily) + enzalutamide 160 mg QD (once daily) |
| Arm B | ACTIVE_COMPARATOR | Participants will receive Placebo BID (twice daily) + enzalutamide 160 mg QD (once daily) |
| Cohort 1 | EXPERIMENTAL | Participants will receive one dose of \[14C\] PF-06821497 by mouth in Period 1. After a washout, participants will receive one dose of PF-06821497 by mouth and one intravenous (IV) infusion of \[14C\] PF-06821497 in Period 2 |
| Name | Type | Description |
|---|---|---|
| PF-06821497 | DRUG | Oral continuous |
| Placebo | DRUG | Oral continuous |
| Enzalutamide | DRUG | Oral continuous |
| Docetaxel | DRUG | 75 mg/m2 IV (every 21 days) |
| Oral [14C] PF-06821497 | DRUG | A single oral dose of \[14C\] PF-06821497 will be administered as an extemporaneous suspension in Period 1 |
| Oral PF-06821497 | DRUG | A single oral dose of PF-06821497 will be administered as an extemporaneous oral suspension in Period 2 |
| IV [14C] PF-06821497 | DRUG | A single IV infusion of \[14C\] PF-06821497 will be administered at the Tmax after administration of the unlabeled oral dose of PF-06821497 in Period 2 |
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features. * Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan. * Progressive disease in the setting of medical or surgical castration. * EC...
Mervometostat is an investigational small molecule being developed by Pfizer for metastatic castration-resistant prostate cancer (mCRPC) and metastatic castration-sensitive prostate cancer (mCSPC). It is also being studied in healthy participants to understand how the drug is processed by the body.
Mervometostat is a small molecule enzyme inhibitor, classified under the -stat (enzyme) target class. It is being studied to treat prostate cancer by targeting specific enzymes involved in cancer growth, though the exact molecular target is not disclosed in the available information.
Mervometostat is developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is also known by the code name PF-06821497.
Mervometostat is in Phase 1 clinical development for metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer. It is also being studied in healthy participants. The drug is investigational and has not been approved by regulatory authorities.
Mervometostat is being studied in several clinical trials. NCT03460977 is a Phase 1 trial in mCRPC, small cell lung cancer, and follicular lymphoma. NCT06392230 is a completed Phase 1 trial in healthy participants. NCT06629779 is a Phase 3 trial in mCRPC, and NCT07028853 is a Phase 3 trial in mCSPC.
Yes, Mervometostat is also known as PF-06821497. The drug is referred to by both names in clinical trial registries and scientific literature, with PF-06821497 being the code name used during early development.