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A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV)

Primary Purpose

Renal Cell Carcinoma

Status

Recruiting

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Pazopanib

Abexinostat

Placebo

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring Renal Cell Carcinoma, Progression-free survival, Abexinostat, Pazopanib, RECIST, Cancer therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.
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.

Sites / Locations

University Of UA Cancer Center(UACC)/DH-SJHMC
University of California Davis Comprehensive Cancer Center
UCSF Helen Diller Family Comphrensive Cancer Center - Hemato
Norton Cancer Institute, Norton Healthcare Pavilion
Ochsner Clinic Foundation
GU Research Network/Urology Cancer Center
Nebraska Cancer Specialists
Northwell Health/Monter Cancer Center
Mainstreet Physicans Care
Precision Cancer Research/Dayton Physicians Network - Treatment
Oregon Health and Science University
St. Luke's Hospital
HOPE Cancer Center of East Texas
Medical Oncology Associates, PS (dba Summit Cancer Centers)
Beijing Cancer HospitalRecruiting
Zhongshan Hospital Affiliated to Fudan University
Fondazione del Piemonte per l'Oncologia_Istituto di Candiolo, IRCCS_ Oncologia Medica
A.O. Cannizzaro_UOS Oncologia Medica
IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) UO Oncologia Medica
Istituto Europeo di Oncologia_Unità Oncologia Medica Urogenitale e Cervico Facciale
Istituto Nazionale dei Tumori-Fondazione Pascale- SC Oncologia Medica
Azienda Ospedaliero-Universitaria Maggiore della Carità Novara_SC Oncologia Medica
Istituti Clinici Scientifici Maugeri Spa-SB_ UO Oncologia Medica
Azienda Ospedaliero Universitaria Pisana_ UO Oncologia Medica Universitaria
Fondazione Policlinico Universitario A. Gemelli, U.O.C. Oncologia Medica
National Cancer Center - Center For Prostate Cancer
CHA Bundang Medical Center, CHA University
Severance Hospital, Yonsei University Health System - Medical Oncology
Asan Medical Center - University of Ulsan College of Medicin
Samsung Medical Center - Hematology-Oncology
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny
Szpitale Pomorskie Sp. z o.o. Oddział Onkologii i Radioterapii
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o. Oddział Onkologii Klinicznej z Pododdziałem Dziennym
Clinical Research Center Sp. z o.o., Medic-R Sp. K.
H.G.U. de Elche
Hospital Universitario Fundación Jiménez Díaz
Hospital Universitario 12 de Octubre
H.U. Virgen de la Victoria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pazopanib plus abexinostat

Pazopanib plus placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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).

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).

Full Information

NCT ID

NCT03592472

First Posted

June 23, 2018

Last Updated

August 18, 2022

Sponsor

Xynomic Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03592472

Brief Title

A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV)

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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 17, 2018 (Actual)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xynomic Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Cell Carcinoma

Keywords

Renal Cell Carcinoma, Progression-free survival, Abexinostat, Pazopanib, RECIST, Cancer therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Masking Description

This is a double-blind study. The sponsor, investigators, study coordinators, and the patients will be blinded to the study drug (abexinostat/placebo).

Allocation

Randomized

Enrollment

413 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pazopanib plus abexinostat

Arm Type

Experimental

Arm Description

Arm Title

Pazopanib plus placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Pazopanib

Other Intervention Name(s)

Votrient®

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Abexinostat

Other Intervention Name(s)

PCI-24781

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Progression-free survival (PFS)

Description

Time Frame

From randomization date to date of first documentation of progression OR death (up to approximately 4 years).

Secondary Outcome Measure Information:

Title

PFS by investigator assessment according to RECIST version 1.1.

Description

Time Frame

From randomization date to date of first documentation of progression OR death (up to approximately 4 years).

Title

Overall survival (OS)

Description

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.

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).

Title

Adverse events by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5

Description

To characterize the safety profile of pazopanib in combination with abexinostat.

Time Frame

From Day 1 until end of treatment visit (up to approximately 4 years).

Title

Objective response rate (ORR)

Description

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.

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).

Title

Duration of response (DOR)

Description

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).

Title

ORR by RECIST version 1.1 in cross-over patient population

Description

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.

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).

Title

DOR by RECIST version 1.1 in cross-over patient population

Description

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.

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).

Title

Mean change from Baseline in Functional Assessment of Cancer Therapy Kidney System Index (FKSI-19) scores

Description

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).

Title

Mean change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT-F) scores

Description

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).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sophia Paspal, Ph.D.

Phone

6104055974

sophia.paspal@xynomicpharma.com

First Name & Middle Initial & Last Name or Official Title & Degree

Rahul Aggarwal, M.D.

rahul.aggarwal@ucsf.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pamela Munster, M.D.

Organizational Affiliation

University of California, San Francisco

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Rahul Aggarwal, M.D.

Organizational Affiliation

University of California, San Francisco

Official's Role

Study Chair

Facility Information:

Facility Name

University Of UA Cancer Center(UACC)/DH-SJHMC

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85004

Country

United States

Individual Site Status

Withdrawn

Facility Name

University of California Davis Comprehensive Cancer Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Individual Site Status

Withdrawn

Facility Name

UCSF Helen Diller Family Comphrensive Cancer Center - Hemato

City

San Francisco

State/Province

California

ZIP/Postal Code

94158

Country

United States

Individual Site Status

Withdrawn

Facility Name

Norton Cancer Institute, Norton Healthcare Pavilion

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Individual Site Status

Completed

Facility Name

Ochsner Clinic Foundation

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70121

Country

United States

Individual Site Status

Completed

Facility Name

GU Research Network/Urology Cancer Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68130

Country

United States

Individual Site Status

Withdrawn

Facility Name

Nebraska Cancer Specialists

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68130

Country

United States

Individual Site Status

Completed

Facility Name

Northwell Health/Monter Cancer Center

City

Lake Success

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Individual Site Status

Withdrawn

Facility Name

Mainstreet Physicans Care

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Individual Site Status

Completed

Facility Name

Precision Cancer Research/Dayton Physicians Network - Treatment

City

Kettering

State/Province

Ohio

ZIP/Postal Code

45409

Country

United States

Individual Site Status

Withdrawn

Facility Name

Oregon Health and Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Individual Site Status

Completed

Facility Name

St. Luke's Hospital

City

Easton

State/Province

Pennsylvania

ZIP/Postal Code

18045

Country

United States

Individual Site Status

Completed

Facility Name

HOPE Cancer Center of East Texas

City

Tyler

State/Province

Texas

ZIP/Postal Code

75701

Country

United States

Individual Site Status

Completed

Facility Name

Medical Oncology Associates, PS (dba Summit Cancer Centers)

City

Spokane

State/Province

Washington

ZIP/Postal Code

99208

Country

United States

Individual Site Status

Withdrawn

Facility Name

Beijing Cancer Hospital

City

Beijing

ZIP/Postal Code

100142

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bixia Tang, MD, PhD

Phone

13810211044

bixiatang_med@126.com

Facility Name

Zhongshan Hospital Affiliated to Fudan University

City

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaoyi Hu, MD, PhD

Phone

13917166233

hu.xiaoyi@zs-hospital.sh.cn

Facility Name

Fondazione del Piemonte per l'Oncologia_Istituto di Candiolo, IRCCS_ Oncologia Medica

City

Candiolo

ZIP/Postal Code

10060

Country

Italy

Individual Site Status

Withdrawn

Facility Name

A.O. Cannizzaro_UOS Oncologia Medica

City

Catania

ZIP/Postal Code

95126

Country

Italy

Individual Site Status

Withdrawn

Facility Name

IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) UO Oncologia Medica

City

Meldola (FC)

ZIP/Postal Code

47014

Country

Italy

Individual Site Status

Withdrawn

Facility Name

Istituto Europeo di Oncologia_Unità Oncologia Medica Urogenitale e Cervico Facciale

City

Milano

ZIP/Postal Code

20141

Country

Italy

Individual Site Status

Withdrawn

Facility Name

Istituto Nazionale dei Tumori-Fondazione Pascale- SC Oncologia Medica

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Individual Site Status

Withdrawn

Facility Name

Azienda Ospedaliero-Universitaria Maggiore della Carità Novara_SC Oncologia Medica

City

Novara

ZIP/Postal Code

28100

Country

Italy

Individual Site Status

Withdrawn

Facility Name

Istituti Clinici Scientifici Maugeri Spa-SB_ UO Oncologia Medica

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Individual Site Status

Withdrawn

Facility Name

Azienda Ospedaliero Universitaria Pisana_ UO Oncologia Medica Universitaria

City

Pisa

ZIP/Postal Code

56126

Country

Italy

Individual Site Status

Withdrawn

Facility Name

Fondazione Policlinico Universitario A. Gemelli, U.O.C. Oncologia Medica

City

Roma

ZIP/Postal Code

'00168

Country

Italy

Individual Site Status

Withdrawn

Facility Name

National Cancer Center - Center For Prostate Cancer

City

Goyang-si

ZIP/Postal Code

10408

Country

Korea, Republic of

Individual Site Status

Completed

Facility Name

CHA Bundang Medical Center, CHA University

City

Seongnam-si

ZIP/Postal Code

13496

Country

Korea, Republic of

Individual Site Status

Completed

Facility Name

Severance Hospital, Yonsei University Health System - Medical Oncology

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Individual Site Status

Completed

Facility Name

Asan Medical Center - University of Ulsan College of Medicin

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Individual Site Status

Completed

Facility Name

Samsung Medical Center - Hematology-Oncology

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Individual Site Status

Withdrawn

Facility Name

Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny

City

Brzozow

ZIP/Postal Code

36-200

Country

Poland

Individual Site Status

Withdrawn

Facility Name

Szpitale Pomorskie Sp. z o.o. Oddział Onkologii i Radioterapii

City

Gdynia

ZIP/Postal Code

81-519

Country

Poland

Individual Site Status

Withdrawn

Facility Name

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o. Oddział Onkologii Klinicznej z Pododdziałem Dziennym

City

Krakow

ZIP/Postal Code

31-826

Country

Poland

Individual Site Status

Completed

Facility Name

Clinical Research Center Sp. z o.o., Medic-R Sp. K.

City

Poznan

ZIP/Postal Code

60-848

Country

Poland

Individual Site Status

Withdrawn

Facility Name

H.G.U. de Elche

City

Elche

ZIP/Postal Code

03203

Country

Spain

Individual Site Status

Withdrawn

Facility Name

Hospital Universitario Fundación Jiménez Díaz

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Individual Site Status

Withdrawn

Facility Name

Hospital Universitario 12 de Octubre

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Individual Site Status

Completed

Facility Name

H.U. Virgen de la Victoria

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Individual Site Status

Withdrawn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV)

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