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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03425201 | Niraparib in Combination with Cabozantinib (XL184) in Patients with Advanced Urothelial Cancer (NICARAGUA) | PHASE1 | COMPLETED | 67 | — | — | Oct 14, 2019 | Jul 31, 2024 | Dec 31, 2024 | 10 | Spain |
Highest dose at which ≤1 out of 6 patients experience a DLT
Time from the date of first dose of study treatment to the date of progression or death (from any cause).
| Arm | Type | Description |
|---|---|---|
| Niraparib plus Cabozantinib | EXPERIMENTAL | Patients will receive niraparib and cabozantinib p.o. once daily in 28-day cycles. In phase I, patients will be accrued to each dose level in cohorts of 6 patients. Escalation will continue until a dose-limiting toxicity (DLT) is observed or the highest dose-level is reached. In phase II study patients will receive niraparib p.o. once daily and cabozantinib p.o. once daily in 28-day cycles at doses recommended in the phase I study. If niraparib or cabozantinib need to be interrupted due to toxicity, patient can continue only with the other drug. |
| Name | Type | Description |
|---|---|---|
| Niraparib plus Cabozantinib | DRUG | Non-randomized trial will comprise 2 stages. A dose escalation phase will characterize the safety, tolerability, DLTs and MTD, of oral niraparib plus cabozantinib in patients with urothelial or renal cell carcinoma. Subsequently, the phase II will further evaluate the safety and antitumor activity of this combination in patients with urothelial carcinoma. |
Inclusion Criteria: Phase I study: 1. Histologically confirmed UC of the urinary tract or renal cell carcinoma 2. Advanced or metastatic disease that is not amenable to curative surgery or radiation 3. Patients must be willing to provide a tumor specimen prior to enrollment 4. Previous therapy: ...