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

NCT00334282.

Study characteristics
Methods Study name: ‐
Study design: randomised, placebo‐controlled trial, phase III
Blinding: quadruple (participant, care provider, investigator, outcomes assessor)
Study dates: April 2006 – April 2007 (date of enrolment)
Date of data cut‐off: March 15, 2010 (final analysis of OS and updated safety data), May 23, 2008 (final PFS analysis)
Location: 25 countries (Argentina, Australia, Austria, Brazil, Chile, China, Czech Republic, Estonia, Greece, Hong Kong, India, Ireland, Italy, Republic of Korea, Latvia, Lithuania, Mexico, New Zealand, Pakistan, Poland, Russian Federation, Slovakia, Tunisia, Ukraine, UK.), types of centres: (100 study locations)
Cross‐over study or cross over permitted: not per design, but cross over was permitted from placebo to pazopanib
Participants Inclusion criteria:

  • all sexes

  • ≥ 18 years of age

  • diagnosis of clear cell RCC

  • locally advanced RCC

  • participants with only one prior systemic treatment for locally advanced or metastatic RCC*

  • first‐line systemic treatment* must be cytokine based


Or,

  • no prior systemic therapy for advanced/metastatic RCC

  • ECOG PS 0 or 1


Exclusion criteria:

  • history of another malignancy

  • current or prior use of an investigational anti‐cancer drug within 4 weeks of start of study

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


Sample size: N=233 treatment‐naive participants
Age (years, median with range): experimental arm: 65 (25‐80), control arm: 60 (25‐81)
Sex (m/f): experimental arm: 61/19, control arm: 109/36
Prognostic factors:

  • ECOG PS, n(%)

    • 0

      • experimental arm: 27(34), control arm: 60 (41)

    • 1

      • experimental arm: 43 (54), control arm: 85 (59)

    • 2

      • experimental arm: 10 (13), control arm: 0 (0)

  • MSKCC risk category, n(%)

    • Favourable

      • experimental arm: 31(39), control arm: 57(39)

    • Intermediate

      • experimental arm: 38(48), control arm: 77(53)

    • Poor

      • experimental arm: 1 (1), control arm: 5 (3)

    • Unkown

      • experimental arm: 10 (13), control arm: 6(4)

  • Prior nephrectomy n(%)

    • Yes

      • experimental arm: 74 (93), control arm: 127 (88)
Interventions Experimental arm (n = 155): Pazopanib (800 mg, oral, once/day)
Control arm (n = 78): Placebo (800mg, oral, once/day)
Outcomes Primary outcome(s)

  • PFS

    • Time frame: up to 2 years


Secondary outcome(s)

  • OS

    • Time frame: up to 2 years

  • Health‐related QoL

    • Time frame: baseline and weeks 6, 12, 18, 24, and 48

  • Safety (SAE)


Relevant to this review but not reported: AE in first‐line participants, TFST, number of (first‐line) participants who discontinued treatment due to an AE
Other outcomes (not relevant to this review): DoR, CR, ORR
Notes Funding sources: GlaxoSmithKline
Declarations of Interests: Quote: "No potential conflict of interest." stated by EL.
Clinical study report available: yes
Study protocol available: yes
Statistical analysis plan available: yes
*Trial included both participants who have received prior treatment and participants who are treatment‐naive. Results are reported separately for the treatment‐naive participants in the publication. Hence, all data reported in this review refers to the treatment‐naive group of participants only.