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

GlaxoSmithKline37 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumours

Interventions

GSK1363089 (formerly XL880)DRUG

GSK1363089 will be available as solid capsules with dose unit of 20, 100 and 200 mg. Subjects will administer GSK1363089 capsules orally

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: * Anticancer therapy within 30 days of the start of treatment, * Received radiation to =25% of bone marrow within 30 days of treatment. * Known brain metastasis, * Uncontrolled intercurrent illness, * HIV positive, * Pregnant or breastfeeding women.

Outcomes

Primary Outcomes

To determine the maximum tolerated dose (MTD) and to evaluate the safety and tolerability of daily oral administration of GSK1363089 in subjects with solid tumors

Time frame: 2 years

Secondary Outcomes

Plasma pharmacokinetics (PK) of daily GSK1363089 in subjects with solid tumors, pharmacodynamic effects of daily GSK1363089, Long-term safety and tolerability of daily GSK1363089, Tumor response after daily administration of GSK1363089

Time frame: 1 year

Data from ClinicalTrials.gov

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