A Study To Determine If Two Different Versions Of Topotecan Have The Same Potency In Patients With Advanced Solid Tumors
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/16/2017 |
| Start Date: | October 4, 2004 |
| End Date: | July 5, 2007 |
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 (4C)
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.
formulation to the currently used oral capsule formulation of topotecan.
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.
We found this trial at
7
sites
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