A phase I-II study to evaluate the efficacy and safety of niraparib in combination with cabozantinib (XL184) in patients with advanced urothelial cancer after failure to first-line platinum-based chemotherapy.

Fundación CRIS de investigación para vencer el cáncer0 sites71 target enrollmentJune 11, 2019

Overview

No summary available.

Registry

who.int

Start Date

June 11, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Fundación CRIS de investigación para vencer el cáncer

•1\. Histologically confirmed Urothelial cancer 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:
•i. Renal cell carcinoma: Prior TKI, anti PD1, anti PD\-L1 and mTOR therapies is allowed
•ii. UC of the urinary tract: \=2 previous chemotherapy regimens (including a platinum\-based regimen). Anti PD1 and anti PD\-L1 is allowed.
•5\. Measurable disease will not be required
•6\. The remaining inclusion/exclusion criteria will be identical to the phase II study
•7\. Recovery to at least grade I from toxicities related to prior treatment unless non clinically significant or stable on supportive therapy
•1\. Age \=18 years

•1\. Participant must not be simultaneously enrolled in any interventional clinical trial
•2\. Major surgery, open biopsy or significant traumatic injury within 8 weeks prior to study entry and complete wound healing at the inclusion
•3\. Participant must not have received investigational therapy \= 4 weeks, or within a time interval less than at least 5 half\-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.
•4\. Progressed while on platinum treatment or within 2 months from completion of platinum\-containing regimen
•5\. Radiation therapy for bone or brain metastases within 4 weeks before first dose of study drug. Other external radiation within 4 weeks before first dose of study drug.
•6\. Participant must not have a known hypersensitivity to niraparib or cabozantinib components or excipients.
•7\. Participant must not have received a transfusion (platelets or red blood cells) \= 4 weeks prior to initiating protocol therapy.
•8\. Participant must not have received colony\-stimulating factors within 4 weeks prior initiating protocol therapy.
•9\. Participant has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted \> 4 weeks and was related to the most recent treatment.
•10\. Known history of myelodysplastic syndrome (MDS) or a pre\-treatment cytogenetic testing result at risk for a diagnosis of MDS/acute myeloid leukemia (AML)