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

Ispinesib In Combination With Capecitabine In Patients With Solid Tumors

Sponsors

Lead sponsor: GlaxoSmithKline

Source GlaxoSmithKline
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.

Overall Status Completed
Start Date November 2004
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Plasma levels for SB-715992 and Capecitabine will be checked at Day 1 for Cycle 1.
Secondary Outcome
Measure Time Frame
- 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
Enrollment 30
Condition
Intervention

Intervention type: Drug

Intervention name: Ispinesib

Intervention type: Drug

Intervention name: Capecitabine

Other name: Ispinesib

Eligibility

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).

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
GSK Clinical Trials, MD Study Director GlaxoSmithKline
Location
facility GSK Investigational Site
Location Countries

United States

Verification Date

October 2008

Responsible Party

Name title: Study Director

Organization: GSK

Keywords
Condition Browse
Study Design Info

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov