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

March 10, 2020 updated by: BioNumerik Pharmaceuticals, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Ellis Fischel Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Karenitecin IV/ Karenitecin tablet
Drug: Karenitecin (BNP1350)
Phase 1 study,dose-escalation design
Other Names:
  • Karenitecin also referred to as BNP1350

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Safety and determination of MTD, and recommended Phase 2 dose
Time Frame: throughout study
throughout study

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics
Time Frame: various timepoints
various timepoints
Tumor response
Time Frame: various timepoints
various timepoints

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioNumerik Pharmaceuticals, Inc.

Collaborators

Crown Bioscience

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

December 1, 2004

First Submitted That Met QC Criteria

December 1, 2004

First Posted (Estimate)

December 2, 2004

Study Record Updates

Last Update Posted (Actual)

March 12, 2020

Last Update Submitted That Met QC Criteria

March 10, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KTN22208

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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