A Phase II Study of GSK1363089 (Formerly XL880) for Papillary Renal-Cell Carcinoma (PRC)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Renal Cell

Treatments: Drug: foretinib (formerly GSK1363089 or XL880)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00726323

MET111644

Details and patient eligibility

About

This clinical study is being conducted at multiple sites to determine the best confirmed response rate, safety, and tolerability of GSK1363089 treatment in papillary renal cell carcinoma. Papillary renal cell carcinoma may be classified into hereditary and sporadic forms; subjects with either classification will be accepted into this study.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed diagnosis of PRC with metastatic disease or bilateral multifocal renal tumors localized to kidneys. Measurable disease, ECOG performance status of </= 2.
• Adequate bone marrow reserve, hepatic, renal, and cardiovascular function.

Exclusion criteria

• Radiation to >/=25% of bone marrow within 14 days of GSK1363089, more than 1 prior anti-cancer therapy, received prior treatment with a c-met inhibitor, brain metastases,
• Any uncontrolled intercurrent illness,
• Pregnant or breastfeeding,
• HIV positive

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

5/9 dosing

Experimental group

Description:

240 mg of foretinib on a 5 day on / 9 day off regimen every 14 days.

Treatment:

Drug: foretinib (formerly GSK1363089 or XL880)

daily dosing

Experimental group

Description:

80 mg foretinib on a daily dosing regimen

Treatment:

Drug: foretinib (formerly GSK1363089 or XL880)