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OpenTrials
Completed

NCT Number: NCT00119171

Ispinesib In Combination With Capecitabine In Patients With 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.

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Key information

Conditions

Solid Tumor Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ispinesib

Drug

Capecitabine

Drug

Other names: Ispinesib

Primary outcomes

  1. Plasma levels for SB-715992 and Capecitabine

    Time frame: will be checked at Day 1 for Cycle 1.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2004
First posted
Jul 13, 2005
Registry last updated
Oct 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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