TRIAL DETAIL

Multicentre Placebo-controlled Double-blinded Phase II Study of Lenvatinib Efficacy in Patients With Locally Advanced or Metastatic GIST (Gastrointestinal Stromal Tumor) After Imatinib/Sunitinib Failure (LENVAGIST)

Drug:	Lenvatinib
Trial Name:	Multicentre Placebo-controlled Double-blinded Phase II Study of Lenvatinib Efficacy in Patients With Locally Advanced or Metastatic GIST (Gastrointestinal Stromal Tumor) After Imatinib/Sunitinib Failure (LENVAGIST)
NCT#:	NCT04193553
Conditions:	Gastrointestinal Stromal Tumor
Status:	Recruiting
Phase:	2	Start Date 01/17/2020	Age of Trial (yrs) 3.2
Treatment Phase:	Gleevec-resistant
Drug Category:	KIT/PDGFra/RET/FGFR/VEGFR inhibitor
Strategy:	Block KIT + Block related tumor signal paths
Trial Type:	Specifically GIST and only GIST
Other Protocol IDs:	ET18-291 LENVAGIST
Sponsor:	Centre Leon Berard
Patient Contact:	Julien GAUTIER +33 4.26.55.68.29 julien.gautier@lyon.unicancer.fr
Contact email:
Contact Phone:
Randomized:	Randomized
IV or Oral:	Oral
Trial Notes:	Inclusion Criteria: I1. Male or female ≥ 18 years at the day of consenting to the study. I2. Patient must have histologically confirmed diagnosis of GIST. I3. Disease must be locally advanced or metastatic. I4. Patient who failed (disease progression and/or intolerance) previously at least to imatinib and sunitinib. Nota Bene: patients with more than 2 previous anticancer treatments are eligible. I5. Patient must have evidence of measurable disease as per the RECIST version 1.1 (Appendix 2). I6. Patient must have documented disease progression. I7. ECOG performance status 0, 1 or 2 (Appendix 3).