SB-715992 In Combination With Docetaxel In Patients With Solid Tumors

Phase 1

Completed

• Conditions: Solid Tumor Cancer

• Registration Number: NCT00169520
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this study is to determine the dose regimen of SB-715992 in combination with docetaxel in patients with solid tumors. SB-715992 and docetaxel were dosed by 1-hour intravenous infusion every 3 weeks (on the same day). A patient may continue to receive treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of both drugs in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment with SB-715992. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-15
• Last Update Posted: 2008-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety and tolerability endpoints will consist of the valuation of adverse events (AEs),vital signs and laboratory values. A dose regimen where 1 of 6 (or 17%) subjects experience a dose-limiting toxicity.	throughout the study

Secondary Outcome Measures

Name	Time	Method
PK endpoints of SB-715992 and docetaxel pending the conduct of the PK interaction portion. Antitumor activity will be assessed every 2 cycles (PD).	every 2 cycles

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 London, United Kingdom