Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03460977 | A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma | PHASE1 | RECRUITING | 453 | — | — | Apr 17, 2018 | Jul 7, 2029 | Jun 5, 2026 | 82 | United States, Bulgaria +6 |
First cycle DLTs will be utilized to determine the MTD
Adverse Events will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version \[4.03\])
Objective response using Response Evaluation Criteria in Lymphoma (RECIL) for lymphoma, Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for solid tumors including Small Cell Lung Cancer (SCLC) and Prostate Cancer Working Group 3 (PCWG3) for Castration Resistant Prostate Cancer (CRPC). Progression-free survival in Part 2B in patients with CRPC.
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version \[4.03\]), and timing.
Vital sign changes from baseline including blood pressure, heart rate, ECG changes.
PCWG3
| Arm | Type | Description |
|---|---|---|
| Dose Escalation (Part 1A) | EXPERIMENTAL | Participants with SCLC, CRPC and FL will receive mevrometostat at escalating dose levels |
| Dose Escalation (Part 1B) | EXPERIMENTAL | Participants with FL will receive mevrometostat at escalating dose levels |
| Dose Escalation (Part 1C) | EXPERIMENTAL | Participants with mCRPC will receive mevrometostat at escalating dose levels. |
| Dose Escalation (Part 2A) | EXPERIMENTAL | Participants with mCRPC and SCLC will receive mevrometostat at escalating dose levels in combination with SOC. |
| Dose Expansion (Part 2B) | EXPERIMENTAL | Participants with CRPC will receive mevrometostat in combination with SOC or SOC alone. |
| Japan Cohort | EXPERIMENTAL | Participants with CRPC will receive mevrometostat at one or two doses |
| China cohort | EXPERIMENTAL | Participants will receive mevrometostat at one or two doses |
| Dose Expansion (Part 2C) | EXPERIMENTAL | Participants with mCRPC will receive mevrometostat at a different dose/dosing regimen than that of Part 2B in combination with SOC |
| BE Substudy | EXPERIMENTAL | In the assessment phase, each enrolled participant will receive single doses of the 2 different mevrometostat formulations in 3 periods with alternating dosing and washout between each dose. In the maintenance phase, each participant will receive mevrometostat 2 times a day and enzalutamide 1 time a day. |
| DDI Substudy | EXPERIMENTAL | The DDI substudy assessment phase will consist of 2 Cohorts, Cohort 1 (monotherapy cohort) and Cohort 2 (combination cohort). In the Cohort 1 assessment phase, each enrolled participant will receive a combination of mevrometostat and itraconazole based on preset schedule. In the Cohort 2 assessment phase, each enrolled participant will receive a combination of mevrometostat, enzalutamide, and itraconazole based on preset schedule. In the maintenance phase, each participant will receive mevrometostat 2 times a day and enzalutamide 1 time a day. |
| Name | Type | Description |
|---|---|---|
| Mervometostat (PF-06821497) | DRUG | Oral continuous |
| Enzalutamide | DRUG | Oral continuous |
| Itraconazole | DRUG | Oral solution |
Part 1 and Part 2 (Closed for enrollment). Part 3 Key Inclusion Criteria: * Histological or cytological diagnosis of castration resistant prostate cancer. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 with expected life expectancy of at least 6 months. * Adequate bone ...