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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01034631 | BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma | PHASE1 | COMPLETED | 154 | — | — | Jan 1, 2010 | Dec 1, 2016 | Jul 11, 2022 | 108 | United States, Australia +1 |
Phase I
Determine the toxicities of BNC105P in combination with everolimus. Drug-related treatment emergent adverse events by CTCAE grade 2 or greater are reported
Improvement in 6-month PFS with the addition of BNC105P to everolimus. Progression is defined using RECIST criteria as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
| Arm | Type | Description |
|---|---|---|
| Combination Arm A: Everolimus + BNC105P | ACTIVE_COMPARATOR | Combination Arm A: Everolimus 10 mg, BNC105P MTD (from Phase 1 study) 21 day cycle |
| Sequential Arm B:Everolimus followed by BNC105P Monotherapy | ACTIVE_COMPARATOR | Sequential Arm B: Everolimus 10 mg, 21 day cycle Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy. |
| Name | Type | Description |
|---|---|---|
| Everolimus | DRUG | Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals |
| BNC105P | DRUG | BNC105P, up to 16 mg/m\^2 |
Inclusion Criteria: * Histological or cytological proof of component (any percent) of clear cell RCC (renal cell carcinoma). * Metastatic or locally advanced unresectable RCC. NOTE: Prior nephrectomy is not mandatory. * Progressive disease after 1-2 prior VEGF-directed tyrosine kinase inhibitors (T...