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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097903
• Other study ID #: KTN22208
• Status: Completed
• Phase: Phase 1
• Start date: May 2004
• Est. completion date: May 2013

Study information

• Verified date: March 2020
• Source: BioNumerik Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2013
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Karenitecin (BNP1350)
Phase 1 study,dose-escalation design

Locations

Country	Name	City	State
United States	Ellis Fischel Cancer Center	Columbia	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
BioNumerik Pharmaceuticals, Inc.	Crown Bioscience, Inc. became karenitecin IND 057250 Sponsor on April 8, 2019

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Safety and determination of MTD, and recommended Phase 2 dose		throughout study
Secondary	Pharmacokinetics		various timepoints
Secondary	Tumor response		various timepoints