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 : August 31, 2018
|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 2019|
|Estimated Study Completion Date :||November 2019|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672463
|Contact: Dena Suthers, RN||405-271-8001 ext email@example.com|
|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|