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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Solid Tumours

Treatments: Drug: GSK1363089 (formerly XL880)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00743067

MET111648

Details and patient eligibility

About

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.

Enrollment: 37 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

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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37 participants in 5 patient groups

Cohort 1

Experimental group

Description:

Cohort 1 will include 60 milligram (mg) of GSK1363089. Dose escalation will be 100% if there is no drug-related AEs of Grade 2 or higher in previous cohort. Dose escalation will be 50% in case there is Grade 2 drug-related AEs in any previous cohort.

Treatment:

Drug: GSK1363089 (formerly XL880)

Cohort 2

Experimental group

Description:

Cohort 2 will include 120 mg of GSK1363089. Dose escalation will be 100% if there is no drug-related AEs of Grade 2 or higher in previous cohort. Dose escalation will be 50% in case there is Grade 2 drug-related AEs in any previous cohort.

Treatment:

Drug: GSK1363089 (formerly XL880)

Cohort 3

Experimental group

Description:

Cohort 3 will include 240 mg of GSK1363089. Dose escalation will be 100% if there is no drug-related AEs of Grade 2 or higher in previous cohort. Dose escalation will be 50% in case there is Grade 2 drug-related AEs in any previous cohort.

Treatment:

Drug: GSK1363089 (formerly XL880)

Cohort 4

Experimental group

Description:

Cohort 4 will include 480 mg of GSK1363089. Dose escalation will be 100% if there is no drug-related AEs of Grade 2 or higher in previous cohort. Dose escalation will be 50% in case there is Grade 2 drug-related AEs in any previous cohort.

Treatment:

Drug: GSK1363089 (formerly XL880)

Cohort 5

Experimental group

Description:

Cohort 5 will include 960 mg of GSK1363089. Dose escalation will be 100% if there is no drug-related AEs of Grade 2 or higher in previous cohort. Dose escalation will be 50% in case there is Grade 2 drug-related AEs in any previous cohort.

Treatment:

Drug: GSK1363089 (formerly XL880)