Trials / Completed
CompletedNCT00097903
Trial of Oral Karenitecin in Patients With Solid Tumors and Lung Cancer
Phase 1 Trial of Oral Karenitecin® in Patients With Solid Tumors"
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- BioNumerik Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the maximum safe dose of orally administered Karenitecin (BNP1350) in patients with solid tumors.
Detailed description
Initially, the safety, side effects and recommended phase 2 dose of oral Karenitecin in patients with advanced solid tumors will be determined. When the recommended phase 2 dose has been determined, the specified dose will be used to determine if Karenitecin is effective in the treatment of patients with relapsed or refractory non-small cell lung cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Karenitecin (BNP1350) | Phase 1 study,dose-escalation design |
Timeline
- Start date
- 2004-05-01
- Primary completion
- 2011-10-01
- Completion
- 2013-05-01
- First posted
- 2004-12-02
- Last updated
- 2020-03-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00097903. Inclusion in this directory is not an endorsement.