A Study To Determine If Two Different Versions Of Topotecan Have The Same Potency In Patients With Advanced Solid Tumors

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Lung Cancer, Small Cell

Treatments: Drug: topotecan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00259935

104864/692

Details and patient eligibility

About

The purpose of this study is to determine the bioequivalence of the new oral capsule formulation to the currently used oral capsule formulation of topotecan.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with advanced solid tumors.
• At least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery.
• Subjects must be free of post-treatment side effects.

Exclusion criteria

• Women who are pregnant or lactating
• Subjects with uncontrolled emesis, regardless of etiology, active infection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

107 participants in 1 patient group

All treated subjects

Experimental group

Description:

Subjects were randomized to receive 4 mg of a new formulation and current formulation of oral topotecan on Days 1 and 8 of Course 1.

Treatment:

Drug: topotecan