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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03641755 | Olaparib + Sapacitabine in BRCA Mutant Breast Cancer | PHASE1 | ACTIVE NOT_RECRUITING | 10 | — | — | Oct 1, 2018 | Oct 22, 2026 | Feb 23, 2026 | 2 | United States |
The dose level immediately below the maximally-administered dose (MAD; defined as the dose level where at least two participants develop dose-limiting toxicity \[DLT\]) will be defined as the MTD. In the situation where none of the dose levels have ≥ 2 DLTs, the MTD will be the highest dose administered. The MTD will be established in a minimum of 6 participants.
The highest dose level below the MAD at which ≤1 out of 6 patients develop DLT. The RPIID will be established in a minimum of 6 participants.
Defined as the percentage of patients achieving a complete response (disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits \["non-CR/non-PD" in non-target lesions\]; and no new lesions) based on RECIST 1.1
| Arm | Type | Description |
|---|---|---|
| Dose Level -1: Sapacitabine (100 mg) + Olaparib (300 mg) | EXPERIMENTAL | * Olaparib will be administered orally twice daily for each 28-day cycle * Sapacitabine will be administered orally once daily on days 1 - 5 and 8 - 12 of every 28-day cycle |
| Dose Level 1: Sapacitabine (150 mg) + Olaparib (300 mg) | EXPERIMENTAL | * Olaparib will be administered orally twice daily for each 28-day cycle * Sapacitabine will be administered orally once daily on days 1 - 5 and 8 - 12 of every 28-day cycle |
| Dose Level 2: Sapacitabine (200 mg) + Olaparib (300 mg) | EXPERIMENTAL | * Olaparib will be administered orally twice daily for each 28-day cycle * Sapacitabine will be administered orally once daily on days 1 - 5 and 8 - 12 of every 28-day cycle |
| Dose Level 3: Sapacitabine (250 mg) + Olaparib (300 mg) | EXPERIMENTAL | * Olaparib will be administered orally twice daily for each 28-day cycle * Sapacitabine will be administered orally once daily on days 1 - 5 and 8 - 12 of every 28-day cycle |
| Name | Type | Description |
|---|---|---|
| Sapacitabine | DRUG | Sapacitabine may help to stop the growth of some types of cancers |
| Olaparib | DRUG | Olaparib is an inhibitor of PARP (poly \[adenosine diphosphate-ribose\] polymerase), which means that it stops PARP from working |
Inclusion Criteria: * Histologically or cytologically confirmed breast cancer that is metastatic or unresectable. * Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function). Testing ma...