A Bioequivalence Study of Two Oral Formulations of Topotecan in Patients With Advanced Solid Tumors

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00046111

Enrollment

Registered

2002-09-23

Start date

2001-09-30

Completion date

2004-04-30

Last updated

2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Small Cell, Solid Tumor Cancer

Keywords

oral, Bioequivalence, Hycamtin, Topotecan

Brief summary

The purpose of this study is to compare two capsules of topotecan made by slightly different methods. This will be done by giving the drug made by the two different methods to patients orally and testing blood levels.

Interventions

DRUGtopotecan

A topoisomerase I inhibitor used for ovarian and lung cancer treatment

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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.	Four weeks

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026