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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2004-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Lung Cancer, Small Cell Solid Tumor Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Primary Group

40 subjects on medium doses of Topotecan and tested for bioequivalence for 4 weeks.

Group Type EXPERIMENTAL

topotecan

Intervention Type DRUG

A topoisomerase I inhibitor used for ovarian and lung cancer treatment

Interventions

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topotecan

A topoisomerase I inhibitor used for ovarian and lung cancer treatment

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No