COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Ispinesib In Combination With Carboplatin In Patients With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00136578
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : September 25, 2017
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to determine the dose regimen of Ispinesib in combination with carboplatin in patients with solid tumors. Ispinesib is dosed by 1-hour intravenous infusion and carboplatin is dosed by 30 minute 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 Ispinesib. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.

Condition or disease Intervention/treatment Phase
Solid Tumours Drug: SB-715992 Drug: carboplatin Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Carboplatin

Arm Intervention/treatment
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.
Drug: SB-715992
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.

Drug: carboplatin
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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

  • Females who are pregnant or nursing.
  • Pre-existing hemolytic anemia.
  • Pre-existing peripheral neuropathy greater than or equal grade 2. Greater than or equal to 4 prior chemotherapy regimens including neoadjuvant/adjuvant chemotherapy, except breast cancer subjects who may have received more than 4 prior chemotherapy regimens.
  • Absolute neutrophil count less than 1,500/mm3.
  • Platelets less than 100,000/mm3.
  • Hemoglobin less than 9 g/dL.
  • Total bilirubin greater than1.5 mg/dL.
  • AST/ALT greater than 2.5 X upper limit of normal.
  • Creatinine clearance less than or equal to 50 mL/min (calculated by the Cockcroft Gault Formula).
  • Known contra-indications to the use of carboplatin, cisplatin, or other platinum-containing compounds.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00136578

Layout table for location information
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37203
United Kingdom
GSK Investigational Site
Newcastle Upon Tyne, Northumberland, United Kingdom, NE4 6BE
Sponsors and Collaborators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline
Layout table for additonal information
Responsible Party: GlaxoSmithKline Identifier: NCT00136578    
Other Study ID Numbers: KSP10014
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Keywords provided by GlaxoSmithKline:
solid tumors
dose limiting toxicity
Additional relevant MeSH terms:
Layout table for MeSH terms
Antineoplastic Agents