Skip to content
Bending the Curve Trial by Trial
?

NAVIGATOR

Avapritinib in advanced PDGFRA D842V-mutant gastrointestinal stromal tumour (NAVIGATOR): a multicentre, open-label, phase 1 trial

Phase 1N = 82NCT02508532

Population
Adults with advanced GIST including PDGFRA D842V-mutant tumours; 82 patients in the safety population, 56 in the PDGFRA D842V activity population (central radiology assessment)
Design
Two-part, open-label, dose-escalation and dose-expansion phase 1 study at 17 sites in nine countries. Oral avapritinib once daily. Patients with PDGFRA D842V mutations were analysed separately (this report). Primary endpoints: maximum tolerated dose, recommended phase 2 dose and safety (escalation); overall response and safety (expansion).
Primary endpoint
ORR
Arms
  • Avapritinib (experimental, n = 56): Avapritinib once daily (recommended phase 2 dose 300 mg)
People
Heinrich MC, Blueprint Medicines
Show the numbers
Results reported for NAVIGATOR
EndpointAnalysisAvapritinibControlEffect
ORRPDGFRA D842V-mutant GIST patients who received avapritinib and had at least one target lesion and one post-baseline assessment by central radiology (n=56)primarymedian follow-up 15.9 monthsHeinrich 202088% (76–95%)—49 of 56 patients responded: 5 complete responses (9%) and 44 partial responses (79%). Maximum tolerated dose 400 mg; recommended phase 2 dose 300 mg.
Results reported for NAVIGATOR
EndpointAnalysisAvapritinibControlEffect
ORRPDGFRA D842V-mutant GIST patients who received avapritinib and had at least one target lesion and one post-baseline assessment by central radiology (n=56)primarymedian follow-up 15.9 monthsHeinrich 202088% (76–95%)—49 of 56 patients responded: 5 complete responses (9%) and 44 partial responses (79%). Maximum tolerated dose 400 mg; recommended phase 2 dose 300 mg.
Primary publication: Heinrich MC, Jones RL, von Mehren M, Schöffski P, Serrano C, Kang YK, et al. Avapritinib in advanced PDGFRA D842V-mutant gastrointestinal stromal tumour (NAVIGATOR): a multicentre, open-label, phase 1 trial. Lancet Oncol. 2020;21(7):935-946. PubMedDOI

Appears in

Sources

  1. Heinrich MC, Jones RL, von Mehren M, Schöffski P, Serrano C, Kang YK, et al. Avapritinib in advanced PDGFRA D842V-mutant gastrointestinal stromal tumour (NAVIGATOR): a multicentre, open-label, phase 1 trial. Lancet Oncol. 2020;21(7):935-946.

    PubMedDOI