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Ispinesib In Combination With Carboplatin In Patients With Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Ispinesib In Combination With Carboplatin In Patients With Solid Tumors

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.

NCT00136578•GlaxoSmithKline

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (2)

GSK Investigational Site

Nashville, Tennessee, United States

GSK Investigational Site

Newcastle upon Tyne, Northumberland, United Kingdom

Key Dates

Start Date

October 20, 2004

Primary Completion Date

October 25, 2006

Completion Date

October 25, 2006

Last Updated

September 25, 2017

Enrollment

ACTUAL participants

Conditions

Solid Tumours

Interventions

SB-715992

DRUG

carboplatin

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 25, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Ispinesib In Combination With Carboplatin In Patients With Solid Tumors

Inclusion Criteria

Exclusion Criteria

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