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

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

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

Study Overview

• Status: Completed
• Conditions: Carcinoma; Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: Karenitecin (BNP1350)

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Ellis Fischel Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics	various timepoints
Tumor response	various timepoints

Collaborators and Investigators

• Sponsor: BioNumerik Pharmaceuticals, Inc.
• Collaborators: Crown Bioscience

Study record dates

Study Major Dates

• Study Start: May 1, 2004
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: December 1, 2004
• First Submitted That Met QC Criteria: December 1, 2004
• First Posted (Estimate): December 2, 2004

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Oral; Carcinoma, Non-Small-Cell Lung; Solid Tumors
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Camptothecin
• Other Study ID Numbers: KTN22208