Clinical trial · Interventional

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

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

NCT00742131CI-TRIAL-00028837completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Solid Tumours	Solid Neoplasm	CURATED_BROADER	0.80

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
GSK1363089	Drug	Foretinib	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Subjects receiving GSK1363089
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.
interventionNames
1. Drug: GSK1363089

Primary outcomes (1)

measure
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
timeFrame
3 years

Secondary outcomes (1)

measure
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

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (1)

BACKGROUNDEder 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. PMID 20472683