No longer a GSK study

Study Description:

This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.

This study is being conducted to provide a direct comparison of the efficacy, safety and tolerability for pazopanib and sunitinib (SUTENT)

GSK Study ID:

108844


Has Results Document Available
ClinicalTrials.gov Identifier:

NCT00720941


EudraCT Number:

2008-002102-19


Study Overview

Medical Conditions

Genitourinary & Gynecologic Cancer

Product

pazopanib

Collaborators

N/A


Date

August 2008 to November 2016

Type

Interventional

Phase

3


Gender

Both

Age

18 Year+

Accepts Healthy Volunteers

none


This study has Protocol summary on ClinicalTrial.gov. Click here to learn more.

Locations

  • Central Contact :

    Not available

  • Central Contact Phone:

    877-379-3718

  • Central Contact Email:

    [email protected]


Study Design

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Study Design: Parallel Assignment
  • Study Classification: Safety/Efficacy Study
  • Masking: Not Available
  • Masked Subject: No
  • Masked Caregiver: No
  • Masked Investigator: No
  • Masked Assessor: No
Primary Outcomes:

  • Progression-free Survival (PFS)
    Timeframe: From randomization until the earliest date of disease progression or death (up to Study Week 191)

Secondary Outcomes:

  • Summary of analysis for the Cancer Treatment Satisfaction Questionnaire (CTSQ) score at Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
    Timeframe: Weeks 4, 10, 16, and 22

  • Change from Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) scale treatment side effects (TSE) domain score at Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
    Timeframe: Baseline; Weeks 4, 10, 16, and 22

  • Change from Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) scale disease-related symptoms-physical (DRS-P) domain score at Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
    Timeframe: Baseline; Weeks 4, 10, 16, and 22

  • Change from Baseline in the Supplementary Quality of Life Questions (SQLQ) limitations due to foot soreness scores at Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
    Timeframe: Baseline; Weeks 4, 10, 16, and 22

  • Change from Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) scale total score at Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
    Timeframe: Baseline; Weeks 4, 10, 16, and 22

  • Duration of Response (DOR)
    Timeframe: From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (up to Study Week 167)

  • Change from Baseline in the Supplementary Quality of Life Questions (SQLQ) scale worst soreness scores at Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
    Timeframe: Baseline; Weeks 4, 10, 16, and 22

  • Number of participants (par.) with serious adverse events (SAEs)/non-serious adverse events (any untoward medical occurrence in a par. administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment)
    Timeframe: From the time of the first dose of study drug to approximately one month after the discontinuation of study drug (up to Study Week 268)

  • Change from Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) scale functional well being (FWB) domain score at Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
    Timeframe: Baseline; Weeks 4, 10, 16, and 22

  • Change from Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) scale disease related symptoms-emotional (DRS-E) domain score at Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
    Timeframe: Baseline; Weeks 4, 10, 16, and 22

  • Number of participants in the indicated categories for overall response as assessed by independent review
    Timeframe: From randomization until the time of a confirmed best response of CR or PR (up to Study Week 167)

  • Medical Resource Utilization (MRU): Assessed as the mean number of non-study medical visits, telephone consultations, hospital days, and emergency room (ER) visits per 30 days through Week 24
    Timeframe: From Day 1 up to Week 24

  • Time to Response
    Timeframe: From randomization until the time of the first documented confirmed complete or partial response (up to Study Week 167)

  • MRU: The mean number of laboratory visits, radiology visits, home healthcare visits, and medical procedures for cycles 1-4. MRU data collected at Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
    Timeframe: Weeks 4, 10, 16, and 22

  • Overall Survival
    Timeframe: From randomization until death (up to Study Week 268)

  • Change from Baseline in the Supplementary Quality of Life Questions (SQLQ) limitations due to mouth and throat soreness score at Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
    Timeframe: Baseline; Weeks 4, 10, 16, and 22

  • Change from Baseline in Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) scale scores at Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
    Timeframe: Baseline (predose); Weeks 4, 10, 16, and 22

Interventions:

  • drug: Pazopanib
  • drug: Sunitinib

Keyword:

  • Pazopanib, Sunitinib, GW786034, Renal cell carcinoma, SUTENT, Locally advanced and/or metastatic renal cell carcinoma
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 927

Clinical Publications:

  • Choueiri T, Figueroa D, Fay A, et al.Correlation of PD-L1 Tumor Expression and Treatment Outcomes in Patients with Renal Cell Carcinoma Receiving Sunitinib or Pazopanib: Results from COMPARZ, a Randomized Controlled Trial.Clin Cancer Res.2014;21(5):1071-7
  • Motzer R, Hutson T, Cella D, et al. Pazopanib Versus Sunitinib in Metastatic Renal-Cell Carcinoma. N Engl J Med. 2013;369(8):722-731.
  • Motzer R, Hutson T, McCann L, et al. Overall Survival for Pazopanib Versus Sunitinib in Metastatic Renal Cell Carcinoma. N Engl J Med. 2014;370(18):1769-1770.