Tests pazopanib with or without abexinostat for advanced kidney cancer
Compares pazopanib plus abexinostat with pazopanib plus placebo in advanced kidney cancer.
Plain-language title generated from the registry record
Registry title: A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV)
Key facts
- Where
- Candiolo, Catania, Meldola (FC), Milan, Naples, Novara, Pavia, Pisa, and Roma, ItalySee the 9 sites
- Phase
- Phase 3
Where in Italy
- Fondazione del Piemonte per l'Oncologia_Istituto di Candiolo, IRCCS_ Oncologia MedicaCandiolo, ItalyNo longer taking part
- A.O. Cannizzaro_UOS Oncologia MedicaCatania, ItalyNo longer taking part
- IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) UO Oncologia MedicaMeldola (FC), ItalyNo longer taking part
- Istituto Europeo di Oncologia_Unità Oncologia Medica Urogenitale e Cervico FaccialeMilan, ItalyNo longer taking part
- Istituto Nazionale dei Tumori-Fondazione Pascale- SC Oncologia MedicaNaples, ItalyNo longer taking part
- Azienda Ospedaliero-Universitaria Maggiore della Carità Novara_SC Oncologia MedicaNovara, ItalyNo longer taking part
- Istituti Clinici Scientifici Maugeri Spa-SB_ UO Oncologia MedicaPavia, ItalyNo longer taking part
- Azienda Ospedaliero Universitaria Pisana_ UO Oncologia Medica UniversitariaPisa, ItalyNo longer taking part
- Fondazione Policlinico Universitario A. Gemelli, U.O.C. Oncologia MedicaRoma, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xynomic Pharmaceuticals, Inc.
- Trial code
- NCT03592472
- Record updated
- 13 April 2025
- Original description
This is a randomized, Phase 3, double-blind, placebo-controlled study of pazopanib plus abexinostat versus pazopanib plus placebo in patients with locally advanced unresectable or metastatic renal cell carcinoma (RCC).Read full original descriptionShow less
A Randomized, Phase 3, Double-blind, Placebo-controlled Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma(RENAVIV)
This is a randomized, Phase 3, double-blind, placebo-controlled study of pazopanib plus abexinostat versus pazopanib plus placebo in patients with locally advanced unresectable or metastatic renal cell carcinoma (RCC).
Inclusion: To be enrolled in the study, patients will be required to meet all of the following criteria:; Patients aged ≥ 18 years at time of study entry; Patients have histologically confirmed RCC with clear cell component; Patients have locally advanced and unresectable or metastatic disease; Measurable disease as assessed only by the investigator (not verified by IRC) according to RECIST version 1.1; Patients must not have had any prior vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor treatment in either (neo)adjuvant or locally advanced/metastatic setting. Up to 1 line of prior cytokine or immune checkpoint inhibitor treatment is allowed in either the (neo)adjuvant or metastatic setting provided screening scans indicate progressive disease (PD) during or following completion of treatment; Patients have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Patients have adequate baseline organ function; Patients have adequate baseline hematologic function; Patient must be at least 2 weeks from last systemic treatment or dose of radiation prior to date of randomization.
Exclusion: Has an additional malignancy requiring treatment within the past 3 years. Patients with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ, and non-muscle invasive urothelial carcinoma; A new pulmonary embolism or deep venous thrombosis diagnosed within 3 months prior to randomization; Use of prohibited medication within 7 days or 5 half-lives, whichever is shorter, prior to first dose of study drug; Poorly controlled hypertension, defined as systolic blood pressure ≥ 160 or diastolic blood pressure ≥ 100 mmHg. Use of anti-hypertensives and rescreening is permitted; New York Heart Association Class III or IV congestive heart failure; Has persistent clinically significant toxicities (Grade ≥ 2; per NCI CTCAE version 5 from previous anticancer therapy (excluding alopecia which is permitted and excluding Grades 2 and 3 laboratory abnormalities if they are not associated with symptoms, are not considered clinically significant by the investigator, and can be managed with available medical therapies); Patients who meet any of the following criteria at Screening will not be enrolled in the study:; Has untreated central nervous system (CNS) metastases. Patients with treated CNS metastases are eligible provided imaging demonstrates no new or progressive metastases obtained at least 4 weeks following completion of treatment. CNS imaging during Screening is not required unless clinically indicated; Has a QTcF interval > 480 msec.