Table. Ongoing trials of alternative sunitinib regimens Trial Trial Title Phase Control group Alternative sunitinib Tumor Type Primary Endpoint Results/Current identifier schedule status NCT02060370 A Phase II Study II None (single- 50 mg 2/1 Metastatic renal Rate of Toxicity defined Completed accrual. of Alternative arm trial) cell carcinoma as percentage of Preliminary data Sunitinib patients who experi- analysis* showed that Scheduling in ence one or more ≥grade the 2/1 schedule did Patients With 3 fatigue, hand-foot syn- not result in a lower Metastatic Renal drome, or diarrhea that rate of toxicity Cell Carcinoma are possibly, probably, compared with (mRCC) or definitely related to historical data from study therapy the 4/2 schedule NCT02689167 Open Label, Random- II Start at 50 mg 4/2. Start at 50 mg 4/2. Metastatic renal Median duration of Ongoing study. ized Multi-centre Phase II When a dose When a dose cell carcinoma treatment calculated Study to Assess the adjustment of adjustment of from sunitinib initiation. Efficacy and Tolerability sunitinib is sunitinib is required of Sunitinib by Dose required switch switch to 50 mg 2/1. Administration Regimen to 37.5 mg 4/2 (Dose Modification or Dose Interruptions) in Patients With Advanced or Metastatic Renal Cell Carcinoma (SURF trial) NCT02398552 A Randomized Phase II II 50 mg 4/2 50 mg 2/1 Metastatic renal Progression-free survival Ongoing study. Kidney Cancer Journal 69 Trial of Sunitinib Four- cell carcinoma weeks on/Two-weeks Off Versus Two-weeks on/One-week Off as First Line Therapy in Metastatic Renal Cell Carcinoma. NCT01499121 A Phase II, Multi-Centre, II None (single-arm Sunitinib is started at Metastatic renal Progression-free survival Completed accrual. Study of the Efficacy and trial) 50 mg /day for 4 weeks. cell carcinoma Preliminary data Safety of Sunitinib Given If there is at least grade 2 analysis** that this on an Individualized toxicity then stay on 50 individualized dosing Schedule as First-Line mg with the number of strategy is feasible Therapy for Metastatic days on sunitinib indi- and safe. The null Renal Cell Cancer vidualized to goal ≤ grade- hypothesis of PFS 8.5 2 toxicity. Dose can be months was rejected reduced to 37.5 mg and at p < 0.001. then to 25 mg if 50 mg or 37.5 mg respectively cannot be tolerated for at least 7 days. If no grade ≥2 toxicity on 50 mg / day for 4 weeks then dose escalate to 62.5 mg 2/1 and up to 75 mg 2/1. NCT02058901 A Phase I Study of High- I None (single-arm Initial dose of sunitinib Locally advanced Determine the maximum Ongoing study. dose, Intermittent trial) 200 mg once weekly or metastatic solid tolerated dose (MTD), Sunitinib in Patients which can be escalated malignanies safety and tolerability With Solid Tumors. by 100 mg increments until the maximum tolerated dose is reached ISRCTN0647 A randomized multi- II/III Sunitinib 50 mg 4/2 Sunitinib 50 mg 4/2 or Locally advanced Stage A: Recruitment rate/ Ongoing study. 3203 stage, phase II/III trial of or pazopanib 800 pazopanib 800 mg or metastatic renal month Stage B: Time to standard first-line therapy mg daily conven- daily drug-free cell carcinoma Strategy Failure (sunitinib or pazopanib) tional continuation interval strategy Stage C/Overall: 2 year comparing temporary strategy OS and averaged quality cessation with allowing adjusted life years (over continuation in the treat= recruitment and follow-up) ment of locally advanced and/or metastatic renal cancer (STAR trial) *http://ascopubs.org/doi/abs/10.1200/JCO.2017.35.6_suppl.533 ** http://meetinglibrary.asco.org/record/144696/abstract
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