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

NCT ID: NCT00097903

Last Updated: 2020-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2013-05-31

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.

Conditions

Carcinoma; Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Karenitecin IV/ Karenitecin tablet

Group Type: EXPERIMENTAL

Karenitecin (BNP1350)

Intervention Type: DRUG

Phase 1 study,dose-escalation design

Interventions

Karenitecin (BNP1350)

Phase 1 study,dose-escalation design

Intervention Type: DRUG

Other Intervention Names

Karenitecin also referred to as BNP1350

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Crown Bioscience

INDUSTRY

Sponsor Role: collaborator

BioNumerik Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ellis Fischel Cancer Center

Columbia, Missouri, United States

Countries

United States

Other Identifiers

KTN22208

Identifier Type: -

Identifier Source: org_study_id