Trial of Oral Karenitecin in Patients With Solid Tumors and Lung Cancer

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the maximum safe dose of orally administered Karenitecin (BNP1350) in patients with solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioNumerik Pharmaceuticals, Inc.
• Collaborator: Crown Bioscience
• Treatments: Camptothecin

Criteria

Inclusion Criteria

• Patients entering the Phase 1 portion of the study must have a histologically or cytologically documented diagnosis of cancer (solid tumors) refractory to conventional therapeutic modalities or for which no conventional treatment exists.

• Patients entering the Phase 2 portion of the study must have a histologically or cytologically documented diagnosis of advanced (Stage IIIb/IV) NSCLC.

• Patients entering the Phase 1 portion of the study can have either measurable or evaluable disease.

• Patients entering the Phase 2 portion of the study must have measurable disease meeting RECIST criteria.

• Patients must have an ECOG performance status of less than or equal to 1.

• More than 2 weeks must have elapsed since previous chemotherapy and 6 weeks from previous treatment with nitrosoureas or mitomycin-C.

• Patients must have fully recovered from the toxic effects of prior therapy.

• Patients entering the Phase 1 portion of the study may have received up to two prior chemotherapy programs including adjuvant or neoadjuvant therapy.

• Patients entering the Phase 2 portion of the study may have received only one prior chemotherapy program including adjuvant or neoadjuvant therapy for NSCLC.

• More than 2 weeks must have elapsed since previous radiation therapy and prior radiation must be less than or equal to 15% of the bone marrow.

• Required Initial Laboratory Data: *ANC ≥ 1,500/mm3, *Platelet count ≥ 100,000/mm3, *SGPT < 1.5 times ULN, *Alkaline phosphatase < 2.0 times ULN, *Bilirubin < 1.5 mg/dl, *Serum creatinine < 1.5 times ULN

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.