Ispinesib In Combination With Capecitabine In Patients With Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00119171
First received: July 5, 2005
Last updated: October 15, 2008
Last verified: October 2008
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 Names:
    • Ispinesib
    • Capecitabine
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00119171

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

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00119171     History of Changes
Other Study ID Numbers: KSP10004
Study First Received: July 5, 2005
Last Updated: October 15, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Safety
tolerability
dose limiting toxicity
solid tumors
capecitabine

Additional relevant MeSH terms:
Neoplasms
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 02, 2014