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

NCT00097903 | Completed Phase 1

• 1 other identifier: KTN22208
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carcinoma; Carcinoma, Non-Small-Cell Lung

Keywords

Carcinoma, Non-Small-Cell Lung; Solid Tumors; Oral

Outcome Measures

Primary Outcomes (1)

• Overall Safety and determination of MTD, and recommended Phase 2 dose

  throughout study

Secondary Outcomes (2)

• Pharmacokinetics

  various timepoints

• Tumor response

  various timepoints

Study Arms (1)

1

EXPERIMENTAL

Karenitecin IV/ Karenitecin tablet

Drug: Karenitecin (BNP1350)

Interventions

Karenitecin (BNP1350) DRUG

Phase 1 study,dose-escalation design

Also known as: Karenitecin also referred to as BNP1350

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioNumerik Pharmaceuticals, Inc.: lead
• Crown Bioscience: collaborator

Study Sites (1)

Ellis Fischel Cancer Center

Columbia, Missouri, 65203, United States

Location

MeSH Terms

Conditions

Carcinoma; Carcinoma, Non-Small-Cell Lung

Interventions

cositecan

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2004
• First Posted: December 2, 2004
• Study Start: May 1, 2004
• Primary Completion: October 1, 2011
• Study Completion: May 1, 2013
• Last Updated: March 12, 2020

Record last verified: 2020-03

Locations

US (1)