Clinical Trial of IV OKN-007 in a Pilot Cohort of Human Recurrent Malignant Glioma Patients (OKN-007)
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|ClinicalTrials.gov Identifier: NCT01672463|
Recruitment Status : Recruiting
First Posted : August 24, 2012
Last Update Posted : September 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Malignant Glioma||Drug: OKN-007||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1b Clinical Trial of IV OKN-007 in a Pilot Cohort of Human Recurrent Malignant Glioma Patients|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||November 2018|
Experimental: All patients
All participants enrolled in this study
Dose escalation/PK cohort: 20 mg/kg, 40 mg/kg or 60 mg/kg OKN-007 via IV infusion, given 3x/week for the first 4 weeks, then 2x/week for the next 4 weeks, then 1x/week thereafter.
Expansion cohort: MTD via IV infusion given 3x/week for the first 4 weeks, then 2x/week for the next 4 weeks, then 1x/week thereafter.
- Number of Adverse events per patient [ Time Frame: 24 months ]The primary objective is to determine MTD, tolerance, and safety of OKN-007 in patients with recurrent GBM and anaplastic glioma.
- PK level in participants [ Time Frame: 24 months ]To determine drug levels of OKN-007 in blood.
- 6 month progression-free survival [ Time Frame: 24 months ]To determine radiographic response rate and 6 month Progression-Free Survival (PFS) of patients treated with OKN-007. PFS is defined as the time from first drug treatment until objective tumor progression or death.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672463
|Contact: Dena Suthers, RN||405-271-8001 ext firstname.lastname@example.org|
|United States, Oklahoma|
|Oklahoma City, Oklahoma, United States, 73104|
|Contact: Dena Suthers, RN 405-271-8001 ext 48971|
|Principal Investigator: James Battiste, MD, PhD|
|Principal Investigator:||James Battiste, MD, PhD||• Oklahoma University|