Clinical Trial of IV OKN-007 in a Pilot Cohort of Human Recurrent Malignant Glioma Patients (OKN-007)
Verified September 2016 by Oblato, Inc.
Information provided by (Responsible Party):
First received: August 21, 2012
Last updated: September 12, 2016
Last verified: September 2016
This is an open label Phase 1b clinical trial of IV administration of OKN-007 in a pilot cohort of human recurrent malignant glioma patients. All patients will have been previously treated with the standard-of-care treatment which includes surgical resection, radiation and chemotherapy, and in some cases treatment for recurrent disease with investigational agents or bevacizumab (Avastin). Patients with unequivocal recurrence (first or greater) established by MRI with and without contrast (e.g., Gd-DTPA (Gadolinium-diethylene triamine pentacetic acid) and meeting inclusion and exclusion criteria, will be eligible for OKN-007 treatment on this protocol.
Recurrent Malignant Glioma
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase 1b Clinical Trial of IV OKN-007 in a Pilot Cohort of Human Recurrent Malignant Glioma Patients
Primary Outcome Measures:
Secondary Outcome Measures:
- PK level in participants [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
To determine drug levels of OKN-007 in blood.
- 6 month progression-free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2017 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Confirmed histopathology of WHO grade III glioma or WHO grade IV GBM at primary diagnosis
- Unequivocal radiographic evidence of tumor progression by MRI within 14 days prior to registration
- Prior radiotherapy
- Prior Temozolomide treatment
- Last cytotoxic chemotherapy 28 or more days or biologic therapy treatment 14 or more days before study start (greater than or equal to 42 days if nitrosourea was administered)
- Karnofsky performance status greater than or equal to 60%
- Full recovery (< grade 1) from the toxic effects of any earlier intervention and a minimum of 28 days from the administration of any investigational agent
Adequate renal, liver and bone marrow function:
- Leukocytes >3,000/mcL
- Absolute neutrophil count >1,500/mcL
- Platelets >100,000/mcL
- Total bilirubin within normal limits
- AST / ALT (SGPT) <2.5 x ULN
- Creatinine within normal limits
- Patients must be >_18 years of age
- Second primary malignancy (except adequately treated basal cell carcinoma of the skin). Patients who had another malignancy in the past, but have been free of active disease for more than 2 years, are eligible
- Have received treatment within the last 28 days with a drug that has not received regulatory approval for any indication at the time of study entry
- Serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete the study
- Patients with moderate or severe renal impairment (calculated creatinine clearance of < 60 mL/min)
- Patients with sodium, potassium, or creatinine serum electrolytes > grade 2.
- Patients with PT/PTT above the upper limit of normal
- Screening ECG abnormality documented by the investigator as medically significant
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01672463
|Oklahoma City, Oklahoma, United States, 73104 |
|Contact: Dena Suthers, RN 405-271-8001 ext 48971 |
|Principal Investigator: James Battiste, MD, PhD |
||James Battiste, MD, PhD
||• Oklahoma University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 21, 2012
||September 12, 2016
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 27, 2016
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue