Ispinesib In Combination With Capecitabine In Patients With Solid Tumors

Solid Tumor Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00119171
• Other study ID #: KSP10004
• Status: Completed
• Phase: Phase 1
• First received: July 5, 2005
• Last updated: October 15, 2008
• Start date: November 2004

Study information

• Verified date: October 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumor Cancer

Intervention

Drug:
• Ispinesib

• Capecitabine

Locations

Country	Name	City	State
United States	GSK Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma levels for SB-715992 and Capecitabine		will be checked at Day 1 for Cycle 1.
Secondary	- Medical history		at screening
Secondary	- ECOG Performance Status, Physical Exam, vitals, & labs		done at screening, Week 1 (each cycle), & follow-up (f/u)
Secondary	- Continuous Adverse Event monitoring		throughout the study