Trial of Oral Karenitecin in Patients With Solid Tumors and Lung Cancer - Full Text View

Sponsored by:	BioNumerik Pharmaceuticals, Inc.
Information provided by:	BioNumerik Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00097903

Purpose

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

Condition	Intervention	Phase
Carcinoma Carcinoma, Non-Small-Cell Lung	Drug: Karenitecin (BNP1350)	Phase I

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Karenitecin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Factorial Assignment, Safety/Efficacy Study
Official Title:	Phase 1 Trial of Oral Karenitecin® in Patients With Solid Tumors"

Further study details as provided by BioNumerik Pharmaceuticals, Inc.:

Primary Outcome Measures:

Overall Safety and determination of MTD, and recommended Phase 2 dose [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics [ Time Frame: various timepoints ] [ Designated as safety issue: No ]
Tumor response [ Time Frame: various timepoints ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	May 2004
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Karenitecin IV/ Karenitecin tablet	Drug: Karenitecin (BNP1350) Phase 1 study,dose-escalation design

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097903

Locations

United States, Missouri
Ellis Fischel Cancer Center	Recruiting
Columbia, Missouri, United States, 65203
Contact: Jeanette Linebaugh, R.N. 573-882-8805 linebaughj@health.missouri.edu
Principal Investigator: Clay Anderson, M.D.
United States, North Carolina
Wake Forest University Baptist Medical Center	Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Michele Harmon, R.N. 336-713-6924 mharmon@wfubmc.edu
Principal Investigator: Antonius Miller, M.D.

Sponsors and Collaborators

BioNumerik Pharmaceuticals, Inc.

More Information

Responsible Party:	BioNumerik ( BioNumerik (Chief Executive Officer) )
Study ID Numbers:	KTN22208
Study First Received:	December 1, 2004
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00097903
Health Authority:	United States: Food and Drug Administration

Keywords provided by BioNumerik Pharmaceuticals, Inc.:

Carcinoma, Non-Small-Cell Lung
Solid Tumors
Oral

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009