Trial of Oral Karenitecin in Patients With Solid Tumors and Lung Cancer
Phase 1
Completed
- Conditions
- CarcinomaCarcinoma, Non-Small-Cell Lung
- Interventions
- Registration Number
- NCT00097903
- Lead Sponsor
- BioNumerik Pharmaceuticals, Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
Not provided
Exclusion Criteria
- Pregnant or lactating women.
- Uncontrolled high blood pressure, uncontrolled diabetes mellitus, unstable angina, symptomatic congestive heart failure (CHF), myocardial infarction (MI) within 6 months, or uncontrolled arrhythmia.
- Phase 2 no previous or concurrent malignancy
- Central Nervous System (CNS) metastasis if neurologically unstable or requiring steroid use.
- Active infection.
- Known positive HIV status.
- Conditions requiring use of H2 blockers or other antacids.
- Inability to provide informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description 1 Karenitecin (BNP1350) Karenitecin IV/ Karenitecin tablet
- Primary Outcome Measures
Name Time Method Overall Safety and determination of MTD, and recommended Phase 2 dose throughout study
- Secondary Outcome Measures
Name Time Method Tumor response various timepoints Pharmacokinetics various timepoints
Trial Locations
- Locations (1)
Ellis Fischel Cancer Center
🇺🇸Columbia, Missouri, United States