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A Study to Determine the Bioequivalence of an Oral Formulation of Topotecan Containing the Drug Substance Manufactured by New Process Relative to the Current Study Formulation of Topotecan in Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Lung Cancer, Small Cell, Solid Tumor Cancer

Thank you

Trial Information

A Study to Determine the Bioequivalence of an Oral Formulation of Topotecan Containing the Drug Substance Manufactured by New Process Relative to the Current Study Formulation of Topotecan in Patients With Advanced Solid Tumors


Inclusion Criteria:



- Written informed consent

- Patients with confirmed advanced solid tumors.

- No prior chemotherapy within 5 years of the diagnosis of SCLC (small cell lung
cancer).

- At least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery.

- Laboratory criteria: Patients must have adequate bone marrow reserve and adequate
kidney and liver function.

Exclusion criteria:

- Women who are pregnant or lactating.

- Patients of child bearing potential refusing to practice adequate contraception.

- Patients with uncontrolled vomiting.

- Active infection.

- Patients with clinical evidence of any gastrointestinal (GI) conditions which would
alter GI absorption or GI motility.

- Patients requiring treatment with cyclosporin A.

- Severe medical problems other than the cancer, that would limit the ability of the
patient to follow study guidelines or expose the patient to extreme risk.

- Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational
therapy for cancer treatment.

- Use of investigational drug within 30 days prior to the first dose of study
medication.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the bioequivalence of new formulation (test) of oral topotecan relative to the current Phase III formulation (reference) of oral topotecan by comparing AUC in patients with advanced solid tumors.

Outcome Time Frame:

Four weeks

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

104864-A/565

NCT ID:

NCT00046111

Start Date:

September 2001

Completion Date:

April 2004

Related Keywords:

  • Lung Cancer, Small Cell
  • Solid Tumor Cancer
  • oral
  • Bioequivalence
  • Hycamtin
  • Topotecan
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Neoplasms

Name

Location

GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SitePittsburgh, Pennsylvania  15213
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteNew York, New York  10021