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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-17

Study Completion Date

2011-08-29

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.

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Detailed Description

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Conditions

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Solid Tumours

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Subjects receiving GSK1363089

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.

Group Type EXPERIMENTAL

GSK1363089

Intervention Type DRUG

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.

Interventions

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GSK1363089

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.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

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Eder JP, Shapiro GI, Appleman LJ, Zhu AX, Miles D, Keer H, Cancilla B, Chu F, Hitchcock-Bryan S, Sherman L, McCallum S, Heath EI, Boerner SA, LoRusso PM. A phase I study of foretinib, a multi-targeted inhibitor of c-Met and vascular endothelial growth factor receptor 2. Clin Cancer Res. 2010 Jul 1;16(13):3507-16. doi: 10.1158/1078-0432.CCR-10-0574. Epub 2010 May 14.

Reference Type BACKGROUND

PMID: 20472683 (View on PubMed)

Study Documents

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