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SB-715992

Phase 1

Solid Tumor Cancer | Small molecule | Oncology |GSK plc|Last Updated: Sep 25, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

SB-715992 · 2 trials · 2 indications

Phase 1 2
NCT00136578Ispinesib In Combination With Carboplatin In Patients With Solid TumorsSolid Tumours
COMPLETED30 Analytics
NCT00169520SB-715992 In Combination With Docetaxel In Patients With Solid TumorsSolid Tumor Cancer
COMPLETED30 Analytics
PHASE1COMPLETED
Ispinesib In Combination With Carboplatin In Patients With Solid Tumors
Solid TumoursUnlock trial analytics
PHASE1COMPLETED
SB-715992 In Combination With Docetaxel In Patients With Solid Tumors
Solid Tumor CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

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.
Up to Day 154
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 Endpoints

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).
Up to 140
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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Subjects receiving carboplatin and SB-715992EXPERIMENTALSubjects 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.

Interventions

NameTypeDescription
SB-715992DRUGSB-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.
carboplatinDRUGCarboplatin 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.
docetaxelDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion criteria: * Histologically or cytologically confirmed diagnosis of an advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy. * ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2. Exclusion criteria: * Fema...

Countries:United StatesUnited Kingdom
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Frequently asked questions about SB-715992

What is SB-715992 used for?

SB-715992 is an investigational small molecule being studied for the treatment of solid tumors and solid tumor cancer. It is in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation for safety and efficacy in patients.

Who makes SB-715992?

SB-715992 is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker symbol GSK. The drug is currently in Phase 1 clinical trials for oncology indications.

What phase is SB-715992 in?

SB-715992 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials for safety and efficacy in patients with solid tumors.

What clinical trials is SB-715992 in?

SB-715992 has been studied in two completed Phase 1 clinical trials. One trial, NCT00136578, evaluated ispinesib in combination with carboplatin in patients with solid tumors. Another trial, NCT00169520, studied SB-715992 in combination with docetaxel in patients with solid tumor cancer.

Is SB-715992 the same as ispinesib?

Yes, SB-715992 is also known as ispinesib. Clinical trial NCT00136578, which evaluated ispinesib in combination with carboplatin in patients with solid tumors, is a study of SB-715992.