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A Phase I, Open-Label, Dose-Escalation Study of the Safety and Tolerability of Ispinesib in Combination With Carboplatin on an Every 21-Day Schedule in Subjects With Advanced Solid Tumors.


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

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Trial Information

A Phase I, Open-Label, Dose-Escalation Study of the Safety and Tolerability of Ispinesib in Combination With Carboplatin 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.

Exclusion criteria:

- Females who are pregnant or nursing.

- Pre-existing hemolytic anemia.

- Pre-existing peripheral neuropathy greater than or equal grade 2. Greater than or
equal to 4 prior chemotherapy regimens including neoadjuvant/adjuvant chemotherapy,
except breast cancer subjects who may have received more than 4 prior chemotherapy
regimens.

- Absolute neutrophil count less than 1,500/mm3.

- Platelets less than 100,000/mm3.

- Hemoglobin less than 9 g/dL.

- Total bilirubin greater than1.5 mg/dL.

- AST/ALT greater than 2.5 X upper limit of normal.

- Creatinine clearance less than or equal to 50 mL/min (calculated by the Cockcroft
Gault Formula).

- Known contra-indications to the use of carboplatin, cisplatin, or other
platinum-containing compounds.

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:

Safety and tolerability endpoints will consist of the valuation of adverse events (AEs),vital signs and laboratory values. A dose regimen where = 1 of 6 (or =17%) subjects experience a dose-limiting toxicity.

Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

KSP10014

NCT ID:

NCT00136578

Start Date:

October 2004

Completion Date:

Related Keywords:

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

Name

Location

GSK Investigational SiteGermantown, Tennessee  38138