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

Completed · Phase 1

Conditions studied: Carcinoma, Carcinoma, Non-Small-Cell Lung

In brief

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

Key facts

Study ID

NCT00097903

Run by

BioNumerik Pharmaceuticals, Inc.

People needed

32

Starts

2004-05-01

Expected to finish

2013-05-01

Last updated by the study team

2020-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Ellis Fischel Cancer Center — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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