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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00119171
Other study ID # KSP10004
Secondary ID
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
Est. completion date
Est. primary completion date
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


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
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