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NCT01147822

Pazopanib Versus Sunitinib in the Treatment of Asian Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma

Completed Phase 2 Results posted Last updated 28 March 2025
What this trial tests

Phase 2 trial testing Pazopanib in Carcinoma, Renal Cell in 367 participants. Completed in 3 September 2021.

Timeline
19 May 2010
Primary endpoint
21 May 2012
3 September 2021

Quick facts

Lead sponsorNovartis Pharmaceuticals
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment367
Start date19 May 2010
Primary completion21 May 2012
Estimated completion3 September 2021
Sites21 locations across China, Taiwan, South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Carcinoma, Renal Cell. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression-free Survival (PFS) Primary · From randomization until the earliest date of disease progression or date of death from any cause, assessed up to approximately 24 months (Primary analysis cut-off date = 21-May-2012) at the same time as the main study VEG108844 (NCT00720941).

PFS was defined as the interval between the date of randomization and the earliest date of progressive disease (PD), as defined by the Independent Review Committee (IRC), or death due to any cause. The IRC defined PD per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1. Per RECIST, PD is defined as a \>=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of \>=1 new lesion.

GroupValue95% CI
Pazopanib 800 mg8.48.3 – 11.1
Sunitinib 50 mg11.18.2 – 14.3
Overall Survival (OS) Secondary · From randomization until date of death from any cause, assessed up to 40 months (Final OS analysis cut-off date = 30-Sep-2013) at the same time as the main study VEG108844 (NCT00720941).

Overall Survival (OS) was defined as the time (in months) from the date of randomization to the date of death due to any cause. If the patient was not known to have died, then OS was censored. The censoring date was date of the last study visit, or contact, until the cut-off date. The cut-off date was not used for last contact date, unless the patient was seen or contacted on that date.

GroupValue95% CI
Pazopanib 800 mg26.723.7 – 41.7
Sunitinib 50 mg33.426.9 – 39.6
Overall Response Rate (ORR) as Assessed by Independent Review Secondary · From randomization until date of radiographic progression, assessed up to approximately 24 months (Primary analysis cut-off date = 21-May-2012) at the same time as the main study VEG108844 (NCT00720941).

Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR was based on RECIST 1.1 response for patients with measurable disease at baseline per central review assessment.

GroupValue95% CI
Pazopanib 800 mg3628.8 – 42.5
Sunitinib 50 mg2114.7 – 26.6
Time to Response Secondary · From randomization until date of radiographic progression, assessed up to approximately 24 months (Primary analysis cut-off date = 21-May-2012) at the same time as the main study VEG108844 (NCT00720941).

Time to response was defined as the time from the start of treatment until the first documented evidence of CR (the disappearance of all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD), whichever comes first. CR and PR were evaluated by an independent review per RECIST, Version 1.

GroupValue95% CI
Pazopanib 800 mg11.96.7 – 12.3
Sunitinib 50 mg17.912.0 – 23.9
Duration of Response (DOR) Secondary · From the date of the first documented response (CR or PR) to the date of first documented progression, assessed up to approximately 24 months (Primary analysis cut-off date = 21-May-2012) at the same time as the main study VEG108844 (NCT00720941).

DOR was defined as the time from the first documented evidence of response (CR or PR) until the first documented sign of disease progression (a \>=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of \>=1 new lesion) or death, if sooner. CR=the disappearance of all target and non-target lesions. PR=at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD.

GroupValue95% CI
Pazopanib 800 mg15.29.9 – 17.9
Sunitinib 50 mg18.012.3 – NA
All Collected Deaths Secondary · Pre-treatment deaths: Up to 21 days prior to treatment. On-treatment deaths: Up to 125 months. Post-treatment deaths: up to 135 months.

Pre-treatment deaths were collected from day of participant's informed consent to the day before first dose of study medication. On-treatment deaths were collected from first dose of study medication to 28 days after last dose of study medication (on-treatment), up to approximately 125 months. Deaths were collected in the post treatment survival follow up from 29 days after last dose of study medication until the end of the study, up to approximately 135 months.

Pre-treatment deaths
GroupValue95% CI
Pazopanib 800 mg0
Sunitinib 50 mg0
On-treatment deaths
GroupValue95% CI
Pazopanib 800 mg7
Sunitinib 50 mg6
Post-treatment deaths
GroupValue95% CI
Pazopanib 800 mg92
Sunitinib 50 mg80
All deaths
GroupValue95% CI
Pazopanib 800 mg99
Sunitinib 50 mg86

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 28 days post-treat follow-up, assessed up to approximately 125 months. Deaths were recorded from study start date until end of survival follow-up phase (end of study), assessed up to approximately 135 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pazopanib 800 mg
Serious: 76/186 (41%)
Deaths: 7/188
Sunitinib 50 mg
Serious: 76/177 (43%)
Deaths: 6/179
Pazopanib 800 mg (Post-Treatment)
Serious: 0
Deaths: 92/179
Sunitinib 50 mg (Post-Treatment)
Serious: 0
Deaths: 80/171

Serious adverse events (126 terms)

ReactionSystemPazopanib 800 mgSunitinib 50 mgPazopanib 800 mg (Post-Tre…Sunitinib 50 mg (Post-Trea…
ThrombocytopeniaBlood and lymphatic system disorders
Alanine aminotransferase increasedInvestigations
Platelet count decreasedInvestigations
PyrexiaGeneral disorders
Hepatic function abnormalHepatobiliary disorders
NeutropeniaBlood and lymphatic system disorders
AnaemiaBlood and lymphatic system disorders
FatigueGeneral disorders
PneumoniaInfections and infestations
Aspartate aminotransferase increasedInvestigations
Lipase increasedInvestigations
Pleural effusionRespiratory, thoracic and mediastinal disorders
AstheniaGeneral disorders
HyponatraemiaMetabolism and nutrition disorders
Febrile neutropeniaBlood and lymphatic system disorders
DiarrhoeaGastrointestinal disorders
IleusGastrointestinal disorders
HyperbilirubinaemiaHepatobiliary disorders
Neutrophil count decreasedInvestigations
Decreased appetiteMetabolism and nutrition disorders
HyperuricaemiaMetabolism and nutrition disorders
Back painMusculoskeletal and connective tissue disorders
Cerebral haemorrhageNervous system disorders
Cerebral infarctionNervous system disorders
Respiratory failureRespiratory, thoracic and mediastinal disorders
Other adverse events (94 terms — click to expand)

ReactionSystemPazopanib 800 mgSunitinib 50 mgPazopanib 800 mg (Post-Tre…Sunitinib 50 mg (Post-Trea…
Palmar-plantar erythrodysaesthesia syndromeSkin and subcutaneous tissue disorders
DiarrhoeaGastrointestinal disorders
HypertensionVascular disorders
FatigueGeneral disorders
ThrombocytopeniaBlood and lymphatic system disorders
Decreased appetiteMetabolism and nutrition disorders
NeutropeniaBlood and lymphatic system disorders
Alanine aminotransferase increasedInvestigations
Aspartate aminotransferase increasedInvestigations
Hair colour changesSkin and subcutaneous tissue disorders
LeukopeniaBlood and lymphatic system disorders
ProteinuriaRenal and urinary disorders
Platelet count decreasedInvestigations
HypothyroidismEndocrine disorders
StomatitisGastrointestinal disorders
White blood cell count decreasedInvestigations
Blood creatinine increasedInvestigations
AnaemiaBlood and lymphatic system disorders
Haemoglobin decreasedInvestigations
Neutrophil count decreasedInvestigations
Blood lactate dehydrogenase increasedInvestigations
NauseaGastrointestinal disorders
Yellow skinSkin and subcutaneous tissue disorders
VomitingGastrointestinal disorders
RashSkin and subcutaneous tissue disorders
Blood bilirubin increasedInvestigations
ConstipationGastrointestinal disorders
Face oedemaGeneral disorders
Blood thyroid stimulating hormone increasedInvestigations
Eyelid oedemaEye disorders
Abdominal pain upperGastrointestinal disorders
EpistaxisRespiratory, thoracic and mediastinal disorders
HeadacheNervous system disorders
Mouth ulcerationGastrointestinal disorders
Back painMusculoskeletal and connective tissue disorders
CoughRespiratory, thoracic and mediastinal disorders
PyrexiaGeneral disorders
Amylase increasedInvestigations
DyspepsiaGastrointestinal disorders
Blood triglycerides increasedInvestigations

Most-reported serious reactions: Thrombocytopenia, Alanine aminotransferase increased, Platelet count decreased, Pyrexia, Hepatic function abnormal, Neutropenia, Anaemia, Fatigue.

Data from ClinicalTrials.gov NCT01147822 adverse events section.

Sponsor's own description

This was a randomized, open label, parallel group, Phase II study to evaluate the efficacy and safety of pazopanib compared to sunitinib in Asian subjects with advanced renal cell carcinoma (RCC) who have not received prior systemic therapy for advanced or metastatic RCC.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Validity and usefulness of a single-item measure of patient-reported bother from side effects of cancer therapy.
    Pearman TP, Beaumont JL, Mroczek D, O'Connor M, et al · · 2018 · cited 83× · PMID 29131323 · DOI 10.1002/cncr.31133
  2. Effects and Side Effects of Using Sorafenib and Sunitinib in the Treatment of Metastatic Renal Cell Carcinoma.
    Randrup Hansen C, Grimm D, Bauer J, Wehland M, et al · · 2017 · cited 53× · PMID 28230776 · DOI 10.3390/ijms18020461
  3. Safety of pazopanib and sunitinib in treatment-naive patients with metastatic renal cell carcinoma: Asian versus non-Asian subgroup analysis of the COMPARZ trial.
    Guo J, Jin J, Oya M, Uemura H, et al · · 2018 · cited 32× · PMID 29788981 · DOI 10.1186/s13045-018-0617-1
  4. Quality-adjusted time without symptoms or toxicity analysis of pazopanib versus sunitinib in patients with renal cell carcinoma.
    Beaumont JL, Salsman JM, Diaz J, Deen KC, et al · · 2016 · cited 30× · PMID 27000445 · DOI 10.1002/cncr.29888
  5. IL8 polymorphisms and overall survival in pazopanib- or sunitinib-treated patients with renal cell carcinoma.
    Xu CF, Johnson T, Garcia-Donas J, Choueiri TK, et al · · 2015 · cited 27× · PMID 25695485 · DOI 10.1038/bjc.2015.64
  6. Hyperbilirubinemia in pazopanib- or sunitinib-treated patients in COMPARZ is associated with UGT1A1 polymorphisms.
    Motzer RJ, Johnson T, Choueiri TK, Deen KC, et al · · 2013 · cited 27× · PMID 24107802 · DOI 10.1093/annonc/mdt394
  7. Early skeletal muscle loss during target therapy is a prognostic biomarker in metastatic renal cell carcinoma patients.
    Gu W, Wu J, Liu X, Zhang H, et al · · 2017 · cited 20× · PMID 28790354 · DOI 10.1038/s41598-017-07955-6
  8. Pazopanib versus sunitinib in Chinese patients with locally advanced or metastatic renal cell carcinoma: pooled subgroup analysis from the randomized, COMPARZ studies.
    Sheng X, Jin J, He Z, Huang Y, et al · · 2020 · cited 14× · PMID 32171288 · DOI 10.1186/s12885-020-6708-8

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01147822.

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