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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by BioNumerik Pharmaceuticals, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
BioNumerik Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00097903
First received: December 1, 2004
Last updated: June 6, 2011
Last verified: February 2010
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Trial of Oral Karenitecin® in Patients With Solid Tumors"

Resource links provided by NLM:


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: March 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Karenitecin IV/ Karenitecin tablet
Drug: Karenitecin (BNP1350)
Phase 1 study,dose-escalation design
Other Name: Karenitecin also referred to as 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.

  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
Columbia, Missouri, United States, 65203
Sponsors and Collaborators
BioNumerik Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: BioNumerik (Chief Executive Officer), BioNumerik
ClinicalTrials.gov Identifier: NCT00097903     History of Changes
Other Study ID Numbers: KTN22208
Study First Received: December 1, 2004
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by BioNumerik Pharmaceuticals, Inc.:
Carcinoma, Non-Small-Cell Lung
Solid Tumors
Oral

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
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
Camptothecin
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 16, 2014