A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV)
NCT ID: NCT03592472
Last Updated: 2025-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
413 participants
INTERVENTIONAL
2018-07-17
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Pazopanib plus abexinostat
Randomized patients will receive a combination of pazopanib plus abexinostat. The patients will receive pazopanib by mouth (p.o.) daily on Days 1 to 28 of each treatment cycle and will receive abexinostat p.o twice daily (BID) on Days 1 to 4, 8 to 11, and 15 to 18 of every 28-day cycle, 2 doses 4 hours apart. Patients will be instructed to take their once- daily oral dose of pazopanib and BID oral dose of abexinostat at the same time each day.
Pazopanib
All patients will receive pazopanib at a starting dose of 800 mg by mouth (p.o.) daily on Days 1 to 28 of each treatment cycle. Patients should be instructed to take their once- daily oral dose of pazopanib at the same time each morning. Each dose of pazopanib should be taken with an 8 oz/240 mL glass of water either 1 hour before or 2 hours after a meal. Patients should be instructed to swallow the tablets whole and not chew them.
Abexinostat
The starting dose and schedule of abexinostat will be 80 mg p.o. BID on Days 1 to 4, 8 to 11, and 15 to 18 of every 28-day cycle, 2 doses 4 hours apart. Each dose of abexinostat should be taken with an 8 oz/240 mL glass of water at least half an hour before meals or more than 2 hours after a meal and must be 4 hours apart. Patients should be instructed to swallow the tablets whole and not chew them.
Pazopanib plus placebo
Randomized patients will receive a combination of pazopanib plus abexinostat matching placebo. The patients will receive pazopanib by mouth (p.o.) daily on Days 1 to 28 of each treatment cycle and will receive abexinostat matching placebo p.o BID on Days 1 to 4, 8 to 11, and 15 to 18 of every 28-day cycle, 2 doses 4 hours apart. Patients will be instructed to take their once- daily oral dose of pazopanib and BID oral dose of placebo at the same time each day.
Pazopanib
All patients will receive pazopanib at a starting dose of 800 mg by mouth (p.o.) daily on Days 1 to 28 of each treatment cycle. Patients should be instructed to take their once- daily oral dose of pazopanib at the same time each morning. Each dose of pazopanib should be taken with an 8 oz/240 mL glass of water either 1 hour before or 2 hours after a meal. Patients should be instructed to swallow the tablets whole and not chew them.
Placebo
The starting dose and schedule of abexinostat matching placebo will be 80 mg p.o. BID on Days 1 to 4, 8 to 11, and 15 to 18 of every 28-day cycle, 2 doses 4 hours apart. Each dose of placebo should be taken with an 8 oz/240 mL glass of water at least half an hour before meals or more than 2 hours after a meal and must be 4 hours apart. Patients should be instructed to swallow the tablets whole and not chew them.
Interventions
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Pazopanib
All patients will receive pazopanib at a starting dose of 800 mg by mouth (p.o.) daily on Days 1 to 28 of each treatment cycle. Patients should be instructed to take their once- daily oral dose of pazopanib at the same time each morning. Each dose of pazopanib should be taken with an 8 oz/240 mL glass of water either 1 hour before or 2 hours after a meal. Patients should be instructed to swallow the tablets whole and not chew them.
Abexinostat
The starting dose and schedule of abexinostat will be 80 mg p.o. BID on Days 1 to 4, 8 to 11, and 15 to 18 of every 28-day cycle, 2 doses 4 hours apart. Each dose of abexinostat should be taken with an 8 oz/240 mL glass of water at least half an hour before meals or more than 2 hours after a meal and must be 4 hours apart. Patients should be instructed to swallow the tablets whole and not chew them.
Placebo
The starting dose and schedule of abexinostat matching placebo will be 80 mg p.o. BID on Days 1 to 4, 8 to 11, and 15 to 18 of every 28-day cycle, 2 doses 4 hours apart. Each dose of placebo should be taken with an 8 oz/240 mL glass of water at least half an hour before meals or more than 2 hours after a meal and must be 4 hours apart. Patients should be instructed to swallow the tablets whole and not chew them.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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 Criteria
* 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).
* 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 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.
* Poorly controlled hypertension, defined as systolic blood pressure ≥ 160 or diastolic blood pressure ≥ 100 mmHg. Use of anti-hypertensives and rescreening is permitted.
* A new pulmonary embolism or deep venous thrombosis diagnosed within 3 months prior to randomization.
* Has a QTcF interval \> 480 msec.
* New York Heart Association Class III or IV congestive heart failure.
* Use of prohibited medication within 7 days or 5 half-lives, whichever is shorter, prior to first dose of study drug.
18 Years
ALL
No
Sponsors
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Xynomic Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pamela Munster, M.D.
Role: STUDY_CHAIR
University of California, San Francisco
Rahul Aggarwal, M.D.
Role: STUDY_CHAIR
University of California, San Francisco
Locations
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University Of UA Cancer Center(UACC)/DH-SJHMC
Phoenix, Arizona, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
UCSF Helen Diller Family Comphrensive Cancer Center - Hemato
San Francisco, California, United States
Norton Cancer Institute, Norton Healthcare Pavilion
Louisville, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
GU Research Network/Urology Cancer Center
Omaha, Nebraska, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Northwell Health/Monter Cancer Center
Lake Success, New York, United States
Mainstreet Physicans Care
Rochester, New York, United States
Precision Cancer Research/Dayton Physicians Network - Treatment
Kettering, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
St. Luke's Hospital
Easton, Pennsylvania, United States
HOPE Cancer Center of East Texas
Tyler, Texas, United States
Medical Oncology Associates, PS (dba Summit Cancer Centers)
Spokane, Washington, United States
Beijing Cancer Hospital
Beijing, , China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, , China
Fondazione del Piemonte per l'Oncologia_Istituto di Candiolo, IRCCS_ Oncologia Medica
Candiolo, , Italy
A.O. Cannizzaro_UOS Oncologia Medica
Catania, , Italy
IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) UO Oncologia Medica
Meldola (FC), , Italy
Istituto Europeo di Oncologia_Unità Oncologia Medica Urogenitale e Cervico Facciale
Milan, , Italy
Istituto Nazionale dei Tumori-Fondazione Pascale- SC Oncologia Medica
Napoli, , Italy
Azienda Ospedaliero-Universitaria Maggiore della Carità Novara_SC Oncologia Medica
Novara, , Italy
Istituti Clinici Scientifici Maugeri Spa-SB_ UO Oncologia Medica
Pavia, , Italy
Azienda Ospedaliero Universitaria Pisana_ UO Oncologia Medica Universitaria
Pisa, , Italy
Fondazione Policlinico Universitario A. Gemelli, U.O.C. Oncologia Medica
Roma, , Italy
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny
Brzozów, , Poland
Szpitale Pomorskie Sp. z o.o. Oddział Onkologii i Radioterapii
Gdynia, , Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o. Oddział Onkologii Klinicznej z Pododdziałem Dziennym
Krakow, , Poland
Clinical Research Center Sp. z o.o., Medic-R Sp. K.
Poznan, , Poland
National Cancer Center - Center For Prostate Cancer
Goyang-si, , South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, , South Korea
Severance Hospital, Yonsei University Health System - Medical Oncology
Seoul, , South Korea
Asan Medical Center - University of Ulsan College of Medicin
Seoul, , South Korea
Samsung Medical Center - Hematology-Oncology
Seoul, , South Korea
H.G.U. de Elche
Elche, , Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
H.U. Virgen de la Victoria
Málaga, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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XYN-602
Identifier Type: -
Identifier Source: org_study_id
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