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

Study summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedKarenitecin (BNP1350)

The study team can explain what participation involves.

Who it may be forCarcinoma · Carcinoma, Non-Small-Cell Lung

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 12, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

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What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?BioNumerik Pharmaceuticals, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: BioNumerik Pharmaceuticals, Inc.
Interventions being studied: Drug: Karenitecin (BNP1350)

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Ellis Fischel Cancer CenterColumbia, Missouri

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 12, 2020. Always confirm current availability with the study team.

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