Table 10.
Selected ongoing phase-3 treatment trials enrolling patients with gastrointestinal stromal tumors (GISTs): (Source: Clinicaltrials.gov, accessed 12 February 2022).
| Trial Number (Name) | Study Title | Study Type | Study Arms | Primary Outcome | Status (on 12 Feb 2022) |
|---|---|---|---|---|---|
| NCT04409223 | Efficacy and safety of famitinib vs. sunitinib for advanced GIST after failure of imatinib | Phase 3, randomized | Famitinib vs. sunitinib | PFS | Recruiting |
| NCT00756509 | Treatment of patients with metastatic or unresectable GIST in first line with nilotinib | Phase 4, single-arm | Nilotinib | Rates of stable SD, PR, and CR | Active, not recruiting |
| NCT05208047 (Peak) | A phase 3 randomized trial of CGT9486 + sunitinib vs. sunitinib in subjects with GIST | Phase 1a and phase 3, randomized | CGT9486 + sunitinib vs. sunitinib | Pharmacokinetics (Cmax, AUC, Tmax, T1/2, CLss/F) and PFS | Recruiting |
| NCT03673501 (Intrigue) | A study of DCC-2618 vs sunitinib in advanced GIST after treatment with imatinib | Phase 3, randomized | DCC-1618 (ripretinib) vs. sunitinib | PFS | Active, not recruiting |
| NCT03353753 (INVICTUS) * | Phase 3 study of DCC-2618 vs. placebo in advanced GIST treated with prior anticancer therapies | Phase 3, randomized | DCC-1618 (ripretinib) vs. placebo | PFS | Active, not recruiting |
| NCT04825574 | Study for patients previously treated in avapritinib clinical trials | Phase 4 | Avapritinib | Safety | Active, not recruiting |
| NCT02260505 (ImadGist) | Efficacy of imatinib maintenance or interruption after 3 years of adjuvant treatment in patients with GIST | Phase 3, randomized | Maintenance imatinib | DFS | Recruiting |
| NCT02847429 | Randomized trial of crenolanib in subjects with D842V mutated GIST | Phase 3, randomized | Crenolanib vs. placebo | PFS | Active, not recruiting |
| NCT02413736 | 3 vs. 5 years of adjuvant Imatinib in patients with operable GIST with a high risk for recurrence: A randomized phase III study | Phase 3, randomized | Experimental: Imatinib at 400 mg/day for 24 months |
RFS | Recruiting |
Abbreviations; PFS, progression-free survival; SD, stable disease; PR, partial response; CR, complete response; Cmax, maximum plasma concentration; AUC, area under the plasma concentration–time curve, Tmax, time to maximum observed plasma concentration; T1/2, time to plasma concentration terminal half-life; CLss/F, apparent total body clearance at steady state; DFS, disease-free survival, RFS, recurrence-free survival. * Results published already.