Renal Cell CarcinomaPhase 3NCT03592472
A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV)
A Phase 3 study testing Pazopanib and Abexinostat in people with Renal Cell Carcinoma, run by Xynomic Pharmaceuticals, Inc. at 38 sites in 6 countries.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Pazopanib and Abexinostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 413 participants
- Where
- 38 sitesin 6 countries
- Study dates
- 17 Jul 2018to 30 Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- Patients who meet any of the following criteria at Screening will not be enrolled in the study:
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
38 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
Rahul Aggarwal, M.D. contact
38 sites in 6 countries
United States14 sites
- Completed
St. Luke's Hospital
Easton, Pennsylvania, 18045
- Withdrawn
Precision Cancer Research/Dayton Physicians Network - Treatment
Kettering, Ohio, 45409
- Withdrawn
Northwell Health/Monter Cancer Center
Lake Success, New York, 11042
- Completed
Norton Cancer Institute, Norton Healthcare Pavilion
Louisville, Kentucky, 40202
- Completed
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
- Withdrawn
GU Research Network/Urology Cancer Center
Omaha, Nebraska, 68130
- Completed
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
- Withdrawn
University Of UA Cancer Center(UACC)/DH-SJHMC
Phoenix, Arizona, 85004
- Completed
Oregon Health and Science University
Portland, Oregon, 97239
- Completed
Mainstreet Physicans Care
Rochester, New York, 14642
- Withdrawn
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
- Withdrawn
UCSF Helen Diller Family Comphrensive Cancer Center - Hemato
San Francisco, California, 94158
- Withdrawn
Medical Oncology Associates, PS (dba Summit Cancer Centers)
Spokane, Washington, 99208
- Completed
HOPE Cancer Center of East Texas
Tyler, Texas, 75701
Italy9 sites
- Withdrawn
Fondazione del Piemonte per l'Oncologia_Istituto di Candiolo, IRCCS_ Oncologia Medica
Candiolo, 10060
- Withdrawn
A.O. Cannizzaro_UOS Oncologia Medica
Catania, 95126
- Withdrawn
IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) UO Oncologia Medica
Meldola (FC), 47014
- Withdrawn
Istituto Europeo di Oncologia_Unità Oncologia Medica Urogenitale e Cervico Facciale
Milan, 20141
- Withdrawn
Istituto Nazionale dei Tumori-Fondazione Pascale- SC Oncologia Medica
Naples, 80131
- Withdrawn
Azienda Ospedaliero-Universitaria Maggiore della Carità Novara_SC Oncologia Medica
Novara, 28100
- Withdrawn
Istituti Clinici Scientifici Maugeri Spa-SB_ UO Oncologia Medica
Pavia, 27100
- Withdrawn
Azienda Ospedaliero Universitaria Pisana_ UO Oncologia Medica Universitaria
Pisa, 56126
- Withdrawn
Fondazione Policlinico Universitario A. Gemelli, U.O.C. Oncologia Medica
Roma, '00168
South Korea5 sites
- Completed
National Cancer Center - Center For Prostate Cancer
Goyang-si, 10408
- Completed
CHA Bundang Medical Center, CHA University
Seongnam-si, 13496
- Completed
Severance Hospital, Yonsei University Health System - Medical Oncology
Seoul, 03722
- Completed
Asan Medical Center - University of Ulsan College of Medicin
Seoul, 05505
- Withdrawn
Samsung Medical Center - Hematology-Oncology
Seoul, 06351
Poland4 sites
- Withdrawn
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny
Brzozów, 36-200
- Withdrawn
Szpitale Pomorskie Sp. z o.o. Oddział Onkologii i Radioterapii
Gdynia, 81-519
- Completed
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o. Oddział Onkologii Klinicznej z Pododdziałem Dziennym
Krakow, 31-826
- Withdrawn
Clinical Research Center Sp. z o.o., Medic-R Sp. K.
Poznan, 60-848
Spain4 sites
- Withdrawn
H.G.U. de Elche
Elche, 03203
- Withdrawn
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
- Completed
Hospital Universitario 12 de Octubre
Madrid, 28041
- Withdrawn
H.U. Virgen de la Victoria
Málaga, 29010
China2 sites, 2 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, 100142
Bixia Tang, MD, PhD, 13810211044, bixiatang_med@126.com
- Not yet recruiting
Zhongshan Hospital Affiliated to Fudan University
Shanghai, 200032
Xiaoyi Hu, MD, PhD, 13917166233, hu.xiaoyi@zs-hospital.sh.cn
About this study
Official title: 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).
Read the detailed description
In this randomized, Phase 3, double-blind, placebo-controlled study, patients will be randomized 2:1 to receive either a combination of pazopanib plus abexinostat or pazopanib plus placebo. At the time of disease progression, patient treatment assignment will be unblinded, and those patients randomized to the pazopanib plus placebo treatment arm will have the option of crossing over to receive treatment with a combination of pazopanib plus abexinostat. After providing written informed consent, patients will be screened for study eligibility within 28 days before their first dose of study drug. After screening assessments, patients who are eligible for inclusion in the study will be randomized and receive their first dose of study drug on Cycle 1 Day 1 (C1D1), within 7 days of randomization. A treatment cycle is 28 days in length. Patients may continue to receive study drug until any of the following events: the development of IRC-verified radiographic progression as assessed by RECIST version 1.1, clinical disease progression, unacceptable toxicity, another discontinuation criterion is met, withdrawal of consent, or closure of the study by the sponsor. No maximum duration of therapy has been set.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Pazopanib, Abexinostat, Placebo
- Keywords
- Renal Cell Carcinoma, Progression-free survival, Abexinostat, Pazopanib, RECIST, Cancer therapy
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PazopanibDrug
Also called Votrient®
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.
AbexinostatDrug
Also called PCI-24781
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pazopanib plus abexinostat | Experimental | 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. Receives: Drug: Pazopanib; Drug: Abexinostat |
| Pazopanib plus placebo | Placebo comparator | 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. Receives: Drug: Pazopanib; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
To compare the PFS between treatment arms. PFS is defined as the time (month) interval between date of randomization and date of radiographic disease progression or death for those without prior evidence of progression, as assessed by blinded Independent Review Committee (IRC) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: From randomization date to date of first documentation of progression OR death (up to approximately 4 years).
Secondary outcomes (9)
PFS by investigator assessment according to RECIST version 1.1.
To compare the PFS between treatment arms by investigator assessment. PFS is defined as the time (month) interval between date of randomization and date of radiographic disease progression or death for those without prior evidence of progression, as assessed by IRC according to RECIST version 1.1.
Measured: From randomization date to date of first documentation of progression OR death (up to approximately 4 years).
Overall survival (OS)
OS is defined as the interval between date of randomization and date of death. The main objective was to compare the OS between treatment arms by investigator assessment.
Measured: From progression or end of study, every 3 months follow up until death, patient withdrawal from study follow-up, or study closure, whichever occurs first (up to approximately 4 years).
Adverse events by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5
To characterize the safety profile of pazopanib in combination with abexinostat.
Measured: From Day 1 until end of treatment visit (up to approximately 4 years).
Objective response rate (ORR)
ORR is defined as the proportion of patients with objective evidence of CR or PR by RECIST version 1.1. The main objective was to compare the ORR between treatment arms by investigator assessment.
Measured: Screening, Cycle 3 Day 1 (C3D1), Cycle 5 Day 1 (C5D1), Cycle 7 Day 1 (C7D1), and on Day 1 of every third cycle (each cycle is 28 days in length) thereafter until end-of-treatment visit (up to approximately 4 years).
Duration of response (DOR)
DOR is defined as the time from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause by RECIST version 1.1. The main objective was to compare the DOR between treatment arms by investigator assessment.
Measured: Screening, Cycle 3 Day 1 (C3D1), C5D1, C7D1, and on Day 1 of every third cycle (each cycle is 28 days in length) thereafter until end-of-treatment visit (up to approximately 4 years).
ORR by RECIST version 1.1 in cross-over patient population
To describe the ORR in patients who cross over to receive pazopanib plus abexinostat at the time of disease progression on pazopanib monotherapy by investigator assessment.
Measured: Screening, Cycle 3 Day 1 (C3D1), C5D1, C7D1, and on Day 1 of every third cycle (each cycle is 28 days in length) thereafter until end-of-treatment visit (up to approximately 4 years).
DOR by RECIST version 1.1 in cross-over patient population
To describe the DOR in patients who cross over to receive pazopanib plus abexinostat at the time of disease progression on pazopanib monotherapy by investigator assessment.
Measured: Screening, Cycle 3 Day 1 (C3D1), C5D1, C7D1, and on Day 1 of every third cycle (each cycle is 28 days in length) thereafter until end-of-treatment visit (up to approximately 4 years).
Mean change from Baseline in Functional Assessment of Cancer Therapy Kidney System Index (FKSI-19) scores
To assess the impact of pazopanib with or without abexinostat on disease-related symptoms and health-related quality of life (QoL) by investigator assessment. QoL will be assessed by measuring change from baseline in FKSI-19. The FKSI-19 assesses disease-related symptoms experienced in the past 7 days. Patients are asked to respond to 12 questions ("I have a lack of energy," "I feel pain," for example) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total score of 0 to 48).
Measured: First day of treatment Cycle1, Cycle 2, Cycle 6 (each cycle is 28 days in length) until end-of-treatment visit (up to approximately 4 years).
Mean change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT-F) scores
To assess the impact of pazopanib with or without abexinostat on disease-related symptoms and QoL by investigator assessment. QoL will be assessed by measuring change from baseline in FACIT-F. The FACIT-F scale measures QoL experienced in the past seven days. The measurement consisted of 5 domains (physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns) assessed on a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much).
Measured: First day of treatment Cycle1, Cycle 2, Cycle 6 (each cycle is 28 days in length) and at end-of-treatment visit (up to approximately 4 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start17 Jul 2018
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 413 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xynomic Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pamela Munster, M.D., Study chair, University of California, San FranciscoRahul Aggarwal, M.D., Study chair, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592472
- Sponsor's protocol ID
- XYN-602
- Status last verified
- Apr 2025
- First submitted
- 23 Jun 2018
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03592472
- Acronym / sponsor ID
- XYN-602
- Conditions
- Renal Cell Carcinoma
- Keywords
- Renal Cell Carcinoma, Progression-free survival, Abexinostat, Pazopanib, RECIST, Cancer therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 413 participants (estimated)
- Lead sponsor
- Xynomic Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
In this randomized, Phase 3, double-blind, placebo-controlled study, patients will be randomized 2:1 to receive either a combination of pazopanib plus abexinostat or pazopanib plus placebo. At the time of disease progression, patient treatment assignment will be unblinded, and those patients randomized to the pazopanib plus placebo treatment arm will have the option of crossing over to receive treatment with a combination of pazopanib plus abexinostat. After providing written informed consent, patients will be screened for study eligibility within 28 days before their first dose of study drug. After screening assessments, patients who are eligible for inclusion in the study will be randomized and receive their first dose of study drug on Cycle 1 Day 1 (C1D1), within 7 days of randomization. A treatment cycle is 28 days in length. Patients may continue to receive study drug until any of the following events: the development of IRC-verified radiographic progression as assessed by RECIST version 1.1, clinical disease progression, unacceptable toxicity, another discontinuation criterion is met, withdrawal of consent, or closure of the study by the sponsor. No maximum duration of therapy has been set.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pazopanib plus abexinostat | Experimental | Drug: Pazopanib, Drug: AbexinostatRandomized 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 plus placebo | Placebo comparator | Drug: Pazopanib, Other: PlaceboRandomized 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- Patients who meet any of the following criteria at Screening will not be enrolled in the study:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PazopanibAlso: Votrient®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. | Drug | Pazopanib plus abexinostat, Pazopanib plus placebo |
| AbexinostatAlso: PCI-24781The 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. | Drug | Pazopanib plus abexinostat |
| PlaceboThe 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 | Pazopanib plus placebo |
Primary outcome
Progression-free survival (PFS)
Time frame: From randomization date to date of first documentation of progression OR death (up to approximately 4 years).
To compare the PFS between treatment arms. PFS is defined as the time (month) interval between date of randomization and date of radiographic disease progression or death for those without prior evidence of progression, as assessed by blinded Independent Review Committee (IRC) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
9 secondary outcomes
PFS by investigator assessment according to RECIST version 1.1.
Time frame: From randomization date to date of first documentation of progression OR death (up to approximately 4 years).
Overall survival (OS)
Time frame: From progression or end of study, every 3 months follow up until death, patient withdrawal from study follow-up, or study closure, whichever occurs first (up to approximately 4 years).
Adverse events by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5
Time frame: From Day 1 until end of treatment visit (up to approximately 4 years).
Objective response rate (ORR)
Time frame: Screening, Cycle 3 Day 1 (C3D1), Cycle 5 Day 1 (C5D1), Cycle 7 Day 1 (C7D1), and on Day 1 of every third cycle (each cycle is 28 days in length) thereafter until end-of-treatment visit (up to approximately 4 years).
Duration of response (DOR)
Time frame: Screening, Cycle 3 Day 1 (C3D1), C5D1, C7D1, and on Day 1 of every third cycle (each cycle is 28 days in length) thereafter until end-of-treatment visit (up to approximately 4 years).
ORR by RECIST version 1.1 in cross-over patient population
Time frame: Screening, Cycle 3 Day 1 (C3D1), C5D1, C7D1, and on Day 1 of every third cycle (each cycle is 28 days in length) thereafter until end-of-treatment visit (up to approximately 4 years).
DOR by RECIST version 1.1 in cross-over patient population
Time frame: Screening, Cycle 3 Day 1 (C3D1), C5D1, C7D1, and on Day 1 of every third cycle (each cycle is 28 days in length) thereafter until end-of-treatment visit (up to approximately 4 years).
Mean change from Baseline in Functional Assessment of Cancer Therapy Kidney System Index (FKSI-19) scores
Time frame: First day of treatment Cycle1, Cycle 2, Cycle 6 (each cycle is 28 days in length) until end-of-treatment visit (up to approximately 4 years).
Mean change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT-F) scores
Time frame: First day of treatment Cycle1, Cycle 2, Cycle 6 (each cycle is 28 days in length) and at end-of-treatment visit (up to approximately 4 years).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Renal Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rahul Aggarwal, M.D. contact
Pamela Munster, M.D. study chair
University of California, San Francisco
Rahul Aggarwal, M.D. study chair
University of California, San Francisco
38 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pazopanib and Abexinostat in people with Renal Cell Carcinoma, run by Xynomic Pharmaceuticals, Inc. at 38 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Italy, South Korea, Poland, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophia Paspal, Ph.D. (6104055974, sophia.paspal@xynomicpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: From randomization date to date of first documentation of progression OR death (up to approximately 4 years).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.