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

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

Detailed Description
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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.

Official Title
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Phase 1 Trial of Oral Karenitecin® in Patients With Solid Tumors

Conditions
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Carcinoma, Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: Karenitecin (BNP1350)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Karenitecin IV/ Karenitecin tablet | Drug: Karenitecin (BNP1350)<br>* Phase 1 study,dose-escalation design<br>* Other names: Karenitecin also referred to as BNP1350;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Safety and determination of MTD, and recommended Phase 2 dose |  | throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | various timepoints | 
| Tumor response |  | various timepoints | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carcinoma, Non-Small-Cell Lung, Solid Tumors, Oral