Study of Karenitecin (BNP1350) in Patients With Brain Tumors

Phase 2

Completed

• Conditions: Brain Neoplasms; Malignant Neoplasms, Brain; Brain Tumors
• Interventions: Drug: Karenitecin (BNP1350)

• Registration Number: NCT00062478
• Lead Sponsor: BioNumerik Pharmaceuticals, Inc.

Brief Summary

The purpose of this study is to evaluate safety and efficacy ofKarenitecin (BNP1350) as a treatment of adults with brain tumors.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-10
• Primary Completion: 2002-08
• Study First Submitted: 2003-06-06
• Study First Submitted QC: 2003-06-11
• Study First Posted: 2003-06-12
• Status Verified: 2019-07
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Karenitecin (BNP1350)	Karenitecin for intravenous use

Primary Outcome Measures

Name	Time	Method
Objective Tumor Response Rate	Randomization to end of treatment

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Randomization to date of death due to any cause
Overall Safety	Randomization to end of study participation

Trial Locations

Locations (1)

For Information call 210-614-1701 for a site near you; 🇺🇸 Durham, North Carolina, United States