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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00062478
Other study ID # KTN20405
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2001

Study information

Verified date July 2019
Source BioNumerik Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date
Est. primary completion date August 2002
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - Confirmed diagnosis of a newly diagnosed glioblastoma multiforme or recurrent/progressive glioblastoma multiforme, anaplastic astrocytoma, or anaplastic oligodendroglioma.

- Evidence of measurable recurrent or residual primary CNS neoplasm.

- An interval of at least 3 weeks between prior surgical resection or 6 weeks between prior radiotherapy or chemotherapy, and enrollment on this protocol unless there is unequivocal evidence of tumor progression after surgery, radiotherapy, or chemotherapy.

- Hematocrit > 29%, ANC > 1,500, platelets > 125,000

- Serum creatinine < 1.5 mg/dl, BUN < 25 mg/dl, serum SGOT and bilirubin < 1.5 times upper limit of normal

- Negative pregnancy test for female patients

Study Design


Intervention

Drug:
Karenitecin (BNP1350)
Karenitecin 1.0 mg/m2 administered as a single 60-minute IV infusion daily for five consecutive days. The cycle is repeated every 21 days until occurrence of progressive disease or unacceptable toxicity.

Locations

Country Name City State
United States For Information call 210-614-1701 for a site near you Durham North Carolina

Sponsors (2)

Lead Sponsor Collaborator
BioNumerik Pharmaceuticals, Inc. Crown Bioscience, Inc. became karenitecin IND 057250 Sponsor on April 8, 2019

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Tumor Response Rate Randomization to end of treatment
Secondary Overall Survival Randomization to date of death due to any cause
Secondary Overall Safety Randomization to end of study participation
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