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. 2013 Jul;6(5):275–286.

Table 4.

Ongoing and Recently Completed Head-to-Head Sequencing Clinical Trials in Patients with mRCC

NCT identifier Study design; planned enrollment Treatment arms Primary end point Secondary end points
NCT00903175 (RECORD-3) Phase 2, open-label, randomized, multicenter trial (n = 390)

  • Everolimus 10 mg once daily orally followed by sunitinib 50 mg once daily orally (4 wks on/2 wks off)

  • Sunitinib 50 mg once daily orally (4 wks on/2 wks off) followed by everolimus 10 mg once daily orally

 PFS after first-line treatment PFS after second-line treatment, ORR, duration of response, OS, and safety
NCT00720941 (COMPARZ) Phase 3, open-label, randomized, multicenter trial

  • Sunitinib 50 mg once daily orally (4 wks on/2 wks off)

  • Pazopanib 800 mg once daily orally

 PFS OS, ORR, duration of response, safety, health outcomes analysis
NCT00474786 (INTORSECT) Phase 3, open-label, randomized, multicenter trial In patients who failed first-line sunitinib therapy:

  • Sorafenib 400 mg twice daily orally

  • Temsirolimus 25 mg IV once weekly

 Safety and tolerability PFS (central assessment) PFS by investigator assessment, RR, OS, proportion of patients with PFS at 12, 24, and 36 wks by independent assessment, duration of response
NCT00732914 (SWITCH) Phase 3, open-label, randomized, multicenter trial

  • Sunitinib 50 mg once daily (4 wks on/2 wks off) followed by sorafenib 400 mg twice daily

  • Sorafenib 400 mg twice daily followed by sunitinib 50 mg once daily (4 wks on/2 wks off)

 Total PFS TTP, OS, disease control rate, cardiotoxicity
NCT01613846 (SWITCH-II) Phase 3, open-label, randomized, multicenter trial

  • Sorafenib 400 mg twice daily followed by pazopanib 800 mg once daily

  • Pazopanib 800 mg once daily followed by sorafenib 400 mg twice daily

 Total PFS TTP, PFS in first and second line, OS, disease control rate, HRQOL

HRQOL indicates health-related quality of life; IV, intravenous; mRCC, metastatic renal cell carcinoma; NCT, National Clinical Trial; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; RR, response rate; TTP, time to progression.