A Dose Escalation Study of the Safety and Pharmacokinetics of GSK1363089 (Formerly XL880) Administered Orally to Subjects With Solid Tumors

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Solid Tumours

Treatments: Drug: GSK1363089

Study type: Interventional

Funder types: Industry

Identifiers

NCT00742131

MET111647

Details and patient eligibility

About

This clinical study is being conducted at two sites to determine the optimum dose, safety, and tolerability of GSK1363089 treatment in adults with solid tumors. This study is no longer recruiting subjects.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed solid tumor which is metastatic or unresectable with no known effective treatment measures,
• ECOG performance status of </= 2.
• Adequate bone marrow reserve, hepatic, renal, and cardiovascular function,
• Negative pregnancy test.

Exclusion criteria

• Chemotherapy within 4-6 weeks of the start of treatment,
• Radiotherapy within 4 weeks of the start of treatment,
• Known brain metastasis,
• Uncontrolled medical disorder such as infection or cardiovascular disease,
• HIV positive,
• Pregnant or breastfeeding women

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Subjects receiving GSK1363089

Experimental group

Description:

Eligible subjects will receive GSK1363089 administered orally as a cinnamon-flavored liquid or as solid capsules with the starting dose for cohort 1 as 0.1 milligram/kilogram. Subjects in cohorts 1, 2, and 3A will receive GSK1363089 in the liquid formulation, while Cohorts 3B, 4, 5, 6, 7, and 8 will receive GSK1363089 in the solid capsule formulation.

Treatment:

Drug: GSK1363089