Ispinesib In Combination With Capecitabine In Patients With Solid Tumors

NCT00119171 | Completed Phase 1

• 1 other identifier: KSP10004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor Cancer

Keywords

Safety; tolerability; dose limiting toxicity; solid tumors; capecitabine

Outcome Measures

Primary Outcomes (1)

• Plasma levels for SB-715992 and Capecitabine

  will be checked at Day 1 for Cycle 1.

Secondary Outcomes (3)

• - Medical history

  at screening

• - ECOG Performance Status, Physical Exam, vitals, & labs

  done at screening, Week 1 (each cycle), & follow-up (f/u)

• - Continuous Adverse Event monitoring

  throughout the study

Interventions

Ispinesib DRUG

Capecitabine DRUG

Also known as: Ispinesib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

ispinesib; Capecitabine

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• GSK Clinical Trials, MD

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 5, 2005
• First Posted: July 13, 2005
• Study Start: November 1, 2004
• Last Updated: October 16, 2008

Record last verified: 2008-10

Locations

US (1)