Carcinoma, Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
Carcinoma, Non-Small-Cell Lung, Solid Tumors, Oral
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.
Interventions
Phase 1 study,dose-escalation design
Sponsors
Crown Bioscience
BioNumerik Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Safety and determination of MTD, and recommended Phase 2 dose | throughout study |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | various timepoints |
| Tumor response | various timepoints |
Countries
United States
Outcome results
None listed