Phase 2 Study of GSK1363089 (Formerly XL880) in Adults With Squamous Cell Cancer of the Head and Neck

NCT ID: NCT00725764

Last Updated: 2017-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-27
• Study Completion Date: 2009-05-02

Brief Summary

This study is being conducted to determine the best confirmed response rate, safety, and tolerability of GSK1363089 treatment in adult subjects with squamous cell carcinoma of the head and neck (SCCHN). GSK1363089 is a new chemical entity that inhibits multiple receptor tyrosine kinases (RTKs) with growth-promoting and angiogenic properties. The primary targets of GSK1363089 are the HGF and vascular endothelial growth factor (VEGF) RTK families (eg, MET, VEGFR2/kinase insert domain receptor [KDR]). Since MET overexpression has been associated with poorer prognosis and MET tyrosine kinase mutations have been reported in SCCHN, inhibition of MET receptor and VEGFR2/KDR activation by agents such as GSK1363089 may be of therapeutic benefit in this patient population.

Conditions

Neoplasms, Head and Neck

Keywords

VEGFR2; XL880; foretinib; Squamous Cell Cancer of the Head and Neck; MET; GSK1363089

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

Participants who qualified for study entry received 240 mg of GSK1363089 (foretinib) on a 5-day on 9-day off schedule every 2 weeks.

Group Type: EXPERIMENTAL

GSK1363089 (foretinib)

Intervention Type: DRUG

Multitargeted tyrosine kinase inhibitor

Interventions

GSK1363089 (foretinib)

Multitargeted tyrosine kinase inhibitor

Intervention Type: DRUG

Other Intervention Names

GSK1363089 (formerly XL880)

Eligibility Criteria

Inclusion Criteria

• The subject has a histologically or cytologically confirmed diagnosis of SCCHN and
• has recurrent and/or metastatic disease
• is not eligible for curative intent surgery or radiotherapy
• has no history of uncontrolled tumor bleeding including hemoptysis in patients with documented pulmonary metastasis.
• The subject has measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as =20 mm with conventional techniques, or as =10 mm with spiral computerized tomography (CT) scan.
• Subject is capable of swallowing capsules.
• Fifteen unstained slides of tumor tissue, archival or fresh, or paraffin block are available, and there - confirmation that samples have been sent for analysis at the central laboratory.
• The subject is at least 18 years old.
• The subject has an Eastern Cooperative Oncology Group (ECOG) performance status =1.
• In the adrenocorticotropic hormone (ACTH) stimulation test, the subject has a serum cortisol level =20 µg/dL (552 nmol/L) 30-90 minutes after injection of ACTH.
• The subject has organ and marrow function as follows: absolute neutrophil count (ANC) =1500/mm3, platelets =100,000/mm3, hemoglobin =9 g/dL, bilirubin =1.5 mg/dL, serum creatinine =1.5 mg/dL and/or calculated creatinine clearance =60 mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 times the upper limit of normal if no liver involvement or =5 times the upper limit of normal with liver involvement.
• The subject has signed the informed consent document.
• Sexually active subjects must use a medically accepted method of contraception during the course of the study.
• Female patients of childbearing potential must have a negative pregnancy test at enrollment.
• The subject has had no other diagnosis of malignancy (unless non-melanoma skin cancer, in situ carcinoma of the cervix, or a malignancy diagnosed =5 years ago, and has had no evidence of disease for 5 years prior to screening for this study).

Exclusion Criteria

• The subject has received radiation to >25% of his or her bone marrow within 30 days of GSK1363089 treatment.
• The subject has received an investigational drug within 30 days (or <5.5 half lives) of the first dose of study drug.
• The subject has received more than one regimen of systemic anticancer therapy for disease that has recurred or is metastatic. This may include either single-agent or combination cytotoxic chemotherapy with radiotherapy or anti-EGFR treatment (eg, cetuximab). Adjuvant or neoadjuvant systemic chemotherapy does not count as a regimen for recurrent or metastatic disease.
• The subject has progressed within 6 months after completion of curative intent (definitive) treatment for localized/locoregionally advanced disease.
• The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade =1 from adverse events (AEs) due to investigational drugs or other medications that were administered more than 30 days before study enrollment with the sole exception of persistent Grade 2 peripheral neuropathy in patients who have previously received platinum-based therapy.
• The subject has known brain metastases.
• The subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active alcoholism, or psychiatric illness that would limit compliance with study requirements.
• The subject is pregnant or breastfeeding.
• The subject is known to be positive for the human immunodeficiency virus (HIV).
• The subject has an allergy or hypersensitivity to components of the GSK1363089 formulation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

Indianapolis, Indiana, United States

GSK Investigational Site

Minneapolis, Minnesota, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Lebanon, New Hampshire, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Nashville, Tennessee, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Morgantown, West Virginia, United States

Countries

United States

Study Documents

Document Type: Dataset Specification

View Document

Document Type: Clinical Study Report

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Study Protocol

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

MET111646

Identifier Type: -

Identifier Source: org_study_id

NCT00482326

Identifier Type: -

Identifier Source: nct_alias