Ispinesib In Combination With Carboplatin In Patients With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00136578|
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : September 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumours||Drug: SB-715992 Drug: carboplatin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Open-Label, Dose-Escalation Study of the Safety and Tolerability of Ispinesib in Combination With Carboplatin on an Every 21-Day Schedule in Subjects With Advanced Solid Tumors.|
|Actual Study Start Date :||October 20, 2004|
|Actual Primary Completion Date :||October 25, 2006|
|Actual Study Completion Date :||October 25, 2006|
Experimental: Subjects receiving carboplatin and SB-715992
Subjects will receive carboplatin on Day 1 as an intravenous (IV) infusion over 30 minutes followed by 1-hour IV infusion of SB-715992 once every 21 days.
SB-715992 will be available either as 5 milliliter (mL) vial containing 4 milligram (mg) of SB-715992 or 4 mL vial containing 5 mg of SB-715992 at a concentration of 1 mg/mL OR a 10 mL vial that contains 10 mg of SB-715992 in a 10 mL solution at a concentration of 1 mg/mL.
Carboplatin will be available as sterile, lyophilized white powder available in single-dose vials containing 50 mg, 150 mg, and 450 mg of carboplatin for administration by IV infusion. Each vial will be reconstituted with either Sterile Water for Injection, USP, 5% Dextrose in Water (D 5 W), or 0.9% Sodium Chloride Injection, USP.
- 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. [ Time Frame: Up to Day 154 ]
- Antitumor activity will be assessed every 2 cycles and will be recorded as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). [ Time Frame: Up to 140 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136578
|United States, Tennessee|
|GSK Investigational Site|
|Nashville, Tennessee, United States, 37203|
|GSK Investigational Site|
|Newcastle Upon Tyne, Northumberland, United Kingdom, NE4 6BE|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|