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NCT00725764 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study of GSK1363089 (Formerly XL880) in Adults With Squamous Cell Cancer of the Head and Neck
A Phase 2 study of Neoplasms, Head and Neck, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 11
- Study locations
NCT00725764: Completed Phase 2 study of Neoplasms, Head and Neck, sponsored by GlaxoSmithKline.
NCT00725764 is a Phase 2 study of Neoplasms, Head and Neck that has completed, run by GlaxoSmithKline. The registered enrollment target is 14 participants, below the 407-participant average among 4 other Neoplasms, Head and Neck trials with a reported enrollment target (97% lower). The trial reports 11 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00725764, a Phase 2 study of Neoplasms, Head and Neck, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 11
- Study locations
Study 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.
Primary Outcome
Best overall response was assessed by the investigator per response evaluation criteria in solid tumors (RECIST). Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Tumor size was recorded at Baseline, and tumor response were recorded approximately every 8 weeks. Tumor response were classified by the invest
Conditions Studied
Interventions
- DRUG GSK1363089 (foretinib)
Study Locations (11)
Texas
- GSK Investigational Site - Houston
- GSK Investigational Site - San Antonio
Georgia
- GSK Investigational Site - Atlanta
Illinois
- GSK Investigational Site - Chicago
Indiana
- GSK Investigational Site - Indianapolis
Minnesota
- GSK Investigational Site - Minneapolis
Missouri
- GSK Investigational Site - St Louis
New Hampshire
- GSK Investigational Site - Lebanon
South Carolina
- GSK Investigational Site - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2007-08-27 |
| Est. Completion | 2009-05-02 |
| Phase | Phase 2 |
What the finished NCT00725764 record still lists
NCT00725764 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 407-participant average among 4 other Neoplasms, Head and Neck trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Neoplasms, Head and Neck appearing as the primary indexed condition, and to 1 intervention - of which GSK1363089 (foretinib) is the first listed.
NCT00725764 lists 11 locations in 10 states (Texas, Georgia, Illinois).
Frequently Asked Questions
What is clinical trial NCT00725764 about?
NCT00725764 is a clinical study titled "Phase 2 Study of GSK1363089 (Formerly XL880) in Adults With Squamous Cell Cancer of the Head and Neck". 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 ...
What is the current status of trial NCT00725764?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2007-08-27. Estimated completion is 2009-05-02.
What conditions does trial NCT00725764 study?
This clinical trial studies the following conditions: Neoplasms, Head and Neck.
What interventions are being tested in trial NCT00725764?
The interventions under investigation include: GSK1363089 (foretinib) (DRUG).
Who is sponsoring clinical trial NCT00725764?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00725764 being conducted?
This trial has 11 study locations across Georgia, Illinois, Indiana, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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