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)

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)

Gastrointestinal Stromal Tumor

Recruiting

2

Start Date 01/17/2020

Age of Trial (yrs) 4.3

Gleevec-resistant

KIT/PDGFra/RET/FGFR/VEGFR inhibitor

Block KIT + Block related tumor signal paths

Specifically GIST and only GIST

ET18-291 LENVAGIST

Centre Leon Berard

Julien GAUTIER +33 4.26.55.68.29 julien.gautier@lyon.unicancer.fr

Randomized

Oral

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).