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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00097903
First Posted: December 2, 2004
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
BioNumerik Pharmaceuticals, Inc.
December 1, 2004
December 2, 2004
September 25, 2017
May 2004
October 2011   (Final data collection date for primary outcome measure)
Overall Safety and determination of MTD, and recommended Phase 2 dose [ Time Frame: throughout study ]
  • Assess potential efficacy
  • Assess safety profile
  • Determine recommended phase 2 dose
  • Characterize and compare pharmacokinetics
Complete list of historical versions of study NCT00097903 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics [ Time Frame: various timepoints ]
  • Tumor response [ Time Frame: various timepoints ]
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
Drug: Karenitecin (BNP1350)
Phase 1 study,dose-escalation design
Other Name: Karenitecin also referred to as BNP1350
Experimental: 1
Karenitecin IV/ Karenitecin tablet
Intervention: Drug: Karenitecin (BNP1350)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
May 2013
October 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00097903
KTN22208
No
Not Provided
Not Provided
BioNumerik Pharmaceuticals, Inc.
BioNumerik Pharmaceuticals, Inc.
Not Provided
Not Provided
BioNumerik Pharmaceuticals, Inc.
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP