Ispinesib In Combination With Capecitabine In Patients With Solid Tumors

October 15, 2008 updated by: GlaxoSmithKline

A Phase I, Open-Label, Dose-Escalation Study of the Safety and Tolerability of Ispinesib in Combination With Capecitabine on an Every 21-Day Schedule in Subjects With Advanced Solid Tumors

The purpose of this study is to determine the dose regimen of Ispinesib in combination with capecitabine in patients with solid tumors. Ispinesib is dosed by 1-hour intravenous infusion every 3 weeks and capecitabine is dosed orally, twice a day for 14 days with a 1 week rest period. 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.
  • Bone marrow function: - ANC greater than 1500/mm3.
  • Platelet count greater than or equal to 100,000/mm3.
  • Hemoglobin greater than 9 g/dL.
  • Renal function: - Calculated creatinine clearance greater than or equal to 50 mL.min.
  • Total bilirubin greater than 1.5 mg/dL.
  • AST/ALT less than 2.5 X upper limit of normal.

Exclusion criteria:

  • Females who are pregnant or nursing.
  • Pre-existing hemolytic anemia.
  • Pre-existing peripheral neuropathy greater than or equal grade 2.
  • Known deficiency in dihydropyrimidine dehydrogenase (DSD).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma levels for SB-715992 and Capecitabine
Time Frame: will be checked at Day 1 for Cycle 1.
will be checked at Day 1 for Cycle 1.

Secondary Outcome Measures

Outcome Measure
Time Frame
- Medical history
Time Frame: at screening
at screening
- ECOG Performance Status, Physical Exam, vitals, & labs
Time Frame: done at screening, Week 1 (each cycle), & follow-up (f/u)
done at screening, Week 1 (each cycle), & follow-up (f/u)
- Continuous Adverse Event monitoring
Time Frame: throughout the study
throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

July 5, 2005

First Submitted That Met QC Criteria

July 5, 2005

First Posted (Estimate)

July 13, 2005

Study Record Updates

Last Update Posted (Estimate)

October 16, 2008

Last Update Submitted That Met QC Criteria

October 15, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSP10004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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