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. 2023 May 4;2023(5):CD013798. doi: 10.1002/14651858.CD013798.pub2

NCT00720941.

Study characteristics
Methods Study name: COMPARZ
Study design: a two‐arm, randomised, phase III
Blinding: none, open‐label
Date of enrolment/randomisation: August 2008 ‐ September 2011
Date of data cut‐off: 21st May 2012 (PFS), 30th Sep. 2013 (for OS, AE and SAE)
Location: 14 countries (Australia, Canada, China, Germany, Ireland, Italy, Japan, Republic of Korea, the Netherlands, Spain, Sweden, Taiwan, UK, USA), types of centres: not reported (227 study locations)
Cross‐over study or cross over permitted: not per design; not reported whether cross over was permitted at some point (e.g. upon progression)
Participants Inclusion criteria:

  • all sexes

  • 18 years and older

  • diagnosis of renal cell carcinoma with clear‐cell component histology

  • measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines

  • received no prior systemic therapy (interleukin‐2, interferon‐alpha, chemotherapy, bevacizumab, mTOR inhibitor, sunitinib, sorafenib or other VEGF TKI) for advanced or metastatic RCC

  • locally advanced or metastatic renal cell carcinoma

  • KPS status of >=70


Exclusion criteria:

  • pregnant or lactating female (unless agrees to refrain from nursing throughout the treatment period and for 14 days following the last dose of study)

  • history of another malignancy (unless have been disease‐free for 3 years)

  • History or clinical evidence of CNS metastases (unless have previously‐treated CNS metastases and meet all 3 of the following criteria are: are asymptomatic, have had no evidence of active CNS metastases for >= 6 months prior to enrolment, and have no requirement for steroids or enzyme‐inducing anticonvulsants)

  • prior use of an investigational or licensed drug that targets VEGF or VEGF receptors (e.g. bevacizumab, sunitinib, sorafenib, etc), or are mTOR inhibitors (e.g. temsirolimus, everolimus, etc)

  • is now undergoing and/or has undergone in the 14 days immediately prior to first dose of study drug, any cancer therapy (surgery, tumour embolisation, chemotherapy, radiation therapy, immunotherapy, biological therapy, or hormonal therapy)


Sample size: N=1110
Age, continuous mean (years, SD): Group 1: 60.9 (10.89), Group 2: 61.2 (10.98)
Sex (m/f): Group 1: 398/159, Group 2: 415/138
Prognostic factors:

  • KPS, n(%)

    • 70 or 80

      • experimental arm: 141 (25), control arm: 130 (24)

    • 90 or 100

      • experimental arm: 416 (75), control arm: 423 (76)

  • Prior nephrectomy, n(%)

    • Yes

      • experimental arm: 459 (82), control arm: 465 (84)

  • MSKCC risk category, n(%)

    • Favourable risk

      • experimental arm: 151 (27), control arm: 152 (27)

    • Intermediate risk

      • experimental arm: 322 (40), control arm: 328 (59)

    • Poor risk

      • experimental arm: 67 (12), control arm: 52 (9)

    • Unknown

      • experimental arm: 17 (3), control arm: 21 (4)

  • Heng risk category, n(%)

    • Favourable risk

      • experimental arm: 142 (23), control arm: 137 (28)

    • Intermediate risk

      • experimental arm: 299 (54), control arm: 308 (56)

    • Poor risk

      • experimental arm: 106 (19), control arm: 94 (17)

    • Unknown

      • experimental arm: 10 (2), control arm: 14 (3)
Interventions Experimental arm (n = 557): Pazopanib (800 mg, oral, once/day)
Control arm (n = 553): Sunitinib (50 mg, oral, once/day)
Outcomes Primary outcome(s)

  • PFS

    • Time frame: from randomisation until the earliest date of disease progression or death (up to study week 191)


Secondary outcome(s)

  • OS

    • Time frame: from randomisation until death (up to study week 268)

  • Number of participants with SAEs/Non‐SAEs (any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment)

    • Time frame: 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)

  • QoL

  • Number of participants who discontinued treatment due to an AE


Relevant to this review but not reported: TFST, Safety (AE, SAE)
Other outcomes (not relevant to this review): laboratory results, MRU, CTSQ, SQLQ, FKSI‐ 19 scale, FACIT‐F scale, DoR
Notes Funding sources: supported by GlaxoSmithKline Pharmaceuticals and Novartis Pharmaceuticals
Declarations of Interests: not reported
Clinical study report available: yes
Study protocol available: yes
Statistical analysis plan available: yes