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

NCT00742131 | Completed Phase 1

• 1 other identifier: MET111647
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Solid Tumours

Keywords

MET inhibitor; c-Met; XL880; GSK1363089; Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Subjects receiving GSK1363089

EXPERIMENTAL

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

Interventions

GSK1363089 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.

Subjects receiving GSK1363089

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (1)

• 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.

  PMID: 20472683 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study MET111647 can be found on the GSK Clinical Study Register.

MeSH Terms

Interventions

GSK 1363089

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: August 27, 2008
• Study Start: March 17, 2005
• Primary Completion: May 13, 2008
• Study Completion: August 29, 2011
• Last Updated: July 31, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share