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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumor Cancer

Thank you

Trial Information

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

Inclusion 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).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Plasma levels for SB-715992 and Capecitabine

Outcome Time Frame:

will be checked at Day 1 for Cycle 1.

Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

KSP10004

NCT ID:

NCT00119171

Start Date:

November 2004

Completion Date:

Related Keywords:

  • Solid Tumor Cancer
  • Safety
  • tolerability
  • dose limiting toxicity
  • solid tumors
  • capecitabine
  • Neoplasms

Name

Location
GSK Investigational Site Fort Worth, Texas  76104