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Ispinesib In Combination With Capecitabine 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.
ClinicalTrials.gov Identifier: NCT00119171
Recruitment Status : Completed
First Posted : July 13, 2005
Last Update Posted : October 16, 2008
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Tumor Cancer Drug: Ispinesib Drug: Capecitabine Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated 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 Capecitabine on an Every 21-Day Schedule in Subjects With Advanced Solid Tumors
Study Start Date : November 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: Ispinesib Drug: Capecitabine
    Other Name: Ispinesib

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  • 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).

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 ClinicalTrials.gov identifier (NCT number): NCT00119171

United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00119171     History of Changes
Other Study ID Numbers: KSP10004
First Posted: July 13, 2005    Key Record Dates
Last Update Posted: October 16, 2008
Last Verified: October 2008

Keywords provided by GlaxoSmithKline:
dose limiting toxicity
solid tumors

Additional relevant MeSH terms:
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents