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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of GSK1363089 (Formerly XL880) Administered Orally to Subjects With Solid Tumors

Conditions
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Solid Tumours

Intervention / Treatment
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* Drug: GSK1363089


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects receiving GSK1363089<br>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. | Drug: GSK1363089<br>* GSK1363089 will be administered orally as a cinnamon-flavored liquid (250 milligrams of GSK1363089 in 50 milliliters liquid [5 milligrams/milliliter] or 1000 milligrams of GSK1363089 in 50 milliliters liquid [20 milligrams/milliliter]) or as solid capsules of 20, 100, and/or 200 milligrams.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the maximum tolerated dose (MTD) and to assess the safety and tolerability of GSK1363089 administered orally (up to twelve different doses) to subjects with solid tumors |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate pharmacokinetic (PK) and pharmacodynamic parameters of GSK1363089, radiographically evaluate the effects of GSK1363089 on tumors, evaluate tumor response after repeat administration of GSK1363089 |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MET inhibitor, c-Met, XL880, GSK1363089, Solid Tumors