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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04553133 | PF-07104091 as a Single Agent and in Combination Therapy | PHASE2 | ACTIVE NOT_RECRUITING | 157 | — | — | Sep 16, 2020 | Dec 31, 2026 | May 6, 2026 | 22 | United States, Argentina +2 |
Number of participants with DLTs, which are typically Grade 3 or higher adverse events will be summarized by dose level
Type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and any laboratory abnormalities will be summarized by dose level
Identify pulse rate readings that are outside the normal range. The number and percentage of participants who experienced significant pulse rate change from baseline will be summarized by dose level
Identify systolic and diastolic readings that are outside the normal range. The number and percentage of participants who experienced significant blood pressure change from baseline will be summarized by dose level
Determine the effect of the drug on QT prolongation. The number and percentage of participants who experienced QT interval prolongation will be summarized by dose level
Percentage of participants with a best overall response of complete response (CR) or partial response (PR) using RECIST 1.1
| Arm | Type | Description |
|---|---|---|
| PF-07104091 | EXPERIMENTAL | CDK2 monotherapy dose escalation |
| PF-07104091 + palbociclib + fulvestrant | EXPERIMENTAL | CDK2 + palbociclib + fulvestrant |
| PF-07104091 + palbociclib + letrozole | EXPERIMENTAL | CDK2 + palbociclib + letrozole |
| PF-07104091 monotherapy dose expansion (SCLC) | EXPERIMENTAL | PF-07104091 monotherapy dose expansion (SCLC) |
| PF-07104091 monotherapy dose expansion (ovarian) | EXPERIMENTAL | PF-07104091 monotherapy dose expansion (ovarian) |
| PF-07104091 + fulvestrant (post CDK4/6) dose expansion | EXPERIMENTAL | PF-07104091 + fulvestrant (post CDK4/6) dose expansion |
| PF-07104091 + fulvestrant (post CDK 4/6) dose escalation | EXPERIMENTAL | CDK2+ fulvestrant (post CDK 4/6) dose escalation |
| Name | Type | Description |
|---|---|---|
| PF-07104091 monotherapy dose escalation | DRUG | PF-07104091 will be administered orally |
| PF-07104091 + palbociclib + fulvestrant | DRUG | PF-07104091 will be administered orally in combination with palbociclib and fulvestrant |
| PF-07104091 + palbociclib + letrozole | DRUG | PF-07104091 will be administered orally in combination with palbociclib and letrozole |
| PF-07104091 monotherapy dose expansion (ovarian) | DRUG | PF-07104091 will be administered orally |
| PF-07104091 monotherapy dose expansion (SCLC) | DRUG | PF-07104091 will be administered orally |
| PF-07104091 + Fulvestrant (post CDK4/6) | DRUG | PF-07104091 will be administered orally in combination with fulvestrant |
| PF-0704091 + Fulvestrant (post CDK4/6) | DRUG | PF-07104091 + fulvestrant (post 4/6) dose expansion |
Inclusion Criteria: * Participants with HR-positive HER2-negative advanced or metastatic breast cancer (received at least two prior lines in the advanced or metastatic setting including one prior line of combined CDK4/6 inhibitor and endocrine therapy and no more than two prior lines of cytotoxic c...