Spots Global Cancer Trial Database for Study of Lenvatinib in Patients With Advanced Cancer and Aberrations in FGF/FGFR Signaling

Study Description

Brief Summary: This is a two center, open label, non-randomized Phase II study of lenvatinib in adult subjects with recurrent or refractory advanced cancers with aberration(s) in FGF/FGFR signaling. Treatment will consist of daily oral administration of Lenvatinib in 28-day cycles.

Detailed Description: This exploratory, histology-independent study will enroll up to 39 subjects regardless of FGF/FGFR aberration or cancer type in order to test the hypothesis that subjects with advanced cancers harboring changes in FGF/FGFR-related genes will respond to the multikinase inhibitor lenvatinib at a higher rate than unselected cancer patients, regardless of the tumor histological subtype. Lenvatinib is a multikinase inhibitor that inhibits FGFR1-4 as well as VEGFR1-3, RET, KIT and PDGFR-beta. It inhibits FGFR1 with an IC50 of 46 nmol/L, which is highly potent at a clinically relevant concentration. Fibroblast growth factor (FGF) and FGF receptor (FGFR) pathway aberrations are common in malignancy, making this pathway a potentially appealing target for anti-cancer therapy. Clinical trial data suggest that targeting FGFR is indeed effective in cancer. However, the majority of such data come from trials in patient populations unselected for FGF/FGFR pathway abnormalities. The true response rates or clinical benefits for those whose cancers harbor FGF/FGFR abnormalities may be higher than observed in unselected patient populations.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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