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

NCT00920816.

Study characteristics
Methods Study name: ‐
Study design: a two‐arm RCT, phase III
Blinding: none, open‐label
Study dates: August 25 2009 – July 27 2012
Date of data cut‐off: July 27, 2012 (for PFS) and December 18, 2014 (for OS)
Location: 14 countries (Bosnia and Herzegovina, Bulgaria, Chile, China, India, Malaysia, Mexico, Philippines, Romania, Russian Federation, South Africa, Taiwan, Ukraine, U.S.A.), types of centres: cancer centres, medical centres, hospitals, university hospitals (125 study locations)
Cross‐over study or cross over permitted: no
Participants Inclusion criteria:

  • all sexes

  • 18 years and older

  • histologically documented metastatic renal cell cancer with a component of a clear cell histology

  • evidence of measurable disease

  • participants with mRCC must have received no prior systemic first‐line therapy or must have progressive disease per RECIST (version 1.0) after one prior systemic first line regimen* for metastatic disease containing sunitinib, cytokine(s), or both


Exclusion criteria:

  • prior treatment for metastatic renal cell cancer with more than one systemic first line therapy

  • major surgery less that 4 weeks or radiation less than 2 weeks of starting study drug


Sample size: N = 288
Age, mean (range): experimental arm: 58 (23‐83), control arm: 58 (20‐77)
Sex (m/f): experimental arm: 134/58, Group 0: 74/22
Prognostic factors:

  • ECOG Performance Scale, n(%)

    • 0

      • experimental arm: 21 (44), control arm: 9 (38)

    • 1

      • experimental arm: 27 (56), control arm: 15 (62)

  • MSKCC risk group

    • Favourable

      • experimental arm: 22 (46), control arm: 10 (42)

    • Intermediate

      • experimental arm: 22 (46), control arm: 13 (54)

    • Poor

      • experimental arm: 3 (6), control arm: 1 (4)

    • Missing

      • experimental arm: 1 (2), control arm: 0 (0)

    • Previous nephrectomy, n(%)

      • Yes

      • experimental arm: 164 (85), control arm: 86 (90)
Interventions Experimental arm (n = 192): axitinib (5 mg, oral, twice/day)
Control arm (n = 96): sorafenib (400 mg, oral, twice/day)
Outcomes Primary outcome(s)

  • PFSl: first‐line participants

    • Time frame: baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107/ 103)


Secondary outcome(s)

  • AEs/SAEs

  • discontinued treatment

  • QoL

  • OS: first‐line participants

    • Time frame: baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)


Relevant to this review but not reported: TFST
Other outcomes (not relevant to this review): OS and PFS in second‐line participants, DoR, OR
Notes Funding sources: AVEO, Bayer, GlaxoSmithKline, Novartis, and Pfizer
Declarations of Interests: Quote: "Angel H. Bair, Brad Rosbrook, and Glen I. Andrews are employees of and own stock in Pfizer. Nicholas J. Vogelzang has served on a speakers bureau for Pfizer. The remaining authors have stated that they have no conflicts of interest."
Clinical study report available: no
Study protocol available: no
Statistical analysis plan available: no
*Data of treatment‐naive participants was extracted for this review.