This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Ispinesib In Combination With Capecitabine In Patients With Solid Tumors

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: July 5, 2005
Last updated: October 15, 2008
Last verified: October 2008
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 Intervention Phase
Solid Tumor Cancer Drug: Ispinesib Drug: Capecitabine Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

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

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

Estimated Enrollment: 30
Study Start Date: November 2004
Intervention Details:
    Drug: Ispinesib Drug: Capecitabine
    Other Name: Ispinesib

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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00119171

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

Responsible Party: Study Director, GSK Identifier: NCT00119171     History of Changes
Other Study ID Numbers: KSP10004
Study First Received: July 5, 2005
Last Updated: October 15, 2008

Keywords provided by GlaxoSmithKline:
dose limiting toxicity
solid tumors

Additional relevant MeSH terms:
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on August 22, 2017