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OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03587038
Recruitment Status : Active, not recruiting
First Posted : July 16, 2018
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Tracking Information
First Submitted Date  ICMJE June 4, 2018
First Posted Date  ICMJE July 16, 2018
Last Update Posted Date November 25, 2019
Actual Study Start Date  ICMJE September 3, 2018
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2018)
The maximum tolerated dose and the type of dose limiting toxicities [ Time Frame: 5 years ]
To determine how well patients are able to tolerate combination of OKN-007, temozolomide, and radiotherapy. Adverse events will be tabulated using MedDRA. The severity of the AE will be graded by the Investigator using the NCI CTCAE, version 4.03.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03587038 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2018)
  • Number of participants who experience progression-free survival [ Time Frame: 5 years ]
    To evaluate the proportion of patients who receive combination OKN-007 and TMZ who do not experience progression
  • Number of participants who comply with study treatment plan [ Time Frame: 5 years ]
    To evaluate the clinical compliance of participants receiving combination OKN-007 and TMZ
  • Number of participants who are able to receive a reduction in steroid dose [ Time Frame: 5 years ]
    To evaluate whether study drug combination allows for a reduced steroid dosage
  • Number of participants who experience overall survival [ Time Frame: 5 years ]
    To evaluate the proportion of patients who receive combination OKN-007 and TMZ who experience overall survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma
Official Title  ICMJE Feasibility Pilot Study of OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma
Brief Summary This is a pilot study exploring the potential benefit of adding OKN-007 with Temozolomide for treatment in patients with malignant Glioblastoma undergoing adjuvant concomitant radiotherapy. This drug combination is expected to have an anti-cancer effect in patients who have experienced disease progression after first line treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE
  • Drug: OKN 007
    400 mg OKN-007/mL in a phosphate buffer
  • Drug: Temozolomide
    75 mg/m2
  • Radiation: Photon/Proton IMRT
    standard of care treatment to be given 1 to 2 hours after OKN-007
Study Arms  ICMJE
  • Experimental: OKN-007 3 days per week plus temozolomide
    OKN-007: 60 mg/kg, IV, 3 times a week Temozolomide: 75 mg/m2, oral, once daily for 42 days Radiotherapy: 60 Gy administered in 30 fractions
    Interventions:
    • Drug: OKN 007
    • Drug: Temozolomide
    • Radiation: Photon/Proton IMRT
  • Experimental: OKN-007 5 days per week and temozolomide
    OKN-007: 60 mg/kg, IV, 5 times a week Temozolomide: 75 mg/m2, oral, once daily for 42 days Radiotherapy: 60 Gy administered in 30 fractions
    Interventions:
    • Drug: OKN 007
    • Drug: Temozolomide
    • Radiation: Photon/Proton IMRT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 12, 2018)
6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2025
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients have newly diagnosed histologically proven WHO grade III or grade IV Glioblastoma Multiforme (GBM).
  • Patients at initial presentation of GBM must undergo an adequate surgical resection of the primary lesion; patients must be registered within 49 days (7 weeks) of the surgery.
  • Patients must have available and be willing to submit a minimum of five unstained slides tumor tissue specimens from the GBM surgery or open biopsy for MGMT status analysis and molecular profile analysis.
  • ECOG performance status within 0 - 2
  • Full recovery (< grade 1) from the adverse events associated with prior surgery or 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; AST / ALT (SGPT) <2.5 x ULN; Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) (except Gilbert's Syndrome, who must have a total bilirubin < 3.0 mg/dL); Creatinine within normal limits
  • Patients must be ≥ 18 years of age
  • Patients must be willing to have blood draws for PK analysis
  • All patients must have a CT or MRI of the brain within 14 days prior to registration. The brain CT or MRI should be performed with intravenous contrast (unless contraindicated).
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent for this protocol in accordance with institutional and federal guidelines.
  • Life expectancy ≥ 3 months, allowing adequate follow up of toxicity evaluation and progression-free survival evaluation;
  • Female patient, if of childbearing potential, has a negative serum pregnancy test within 72 hours of taking study medication and agrees to abstain from activities that could result in pregnancy from enrollment through 120 days after the last dose of study treatment
  • Male patient agrees to use an adequate method of contraception
  • Birth control should be used from the signing of the patient consent form and for 120 days following the last dose of study treatment.
  • In addition, men must not donate sperm during study therapy and for 120 days after receiving the last dose of study treatment.

Exclusion Criteria:

  • 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.
  • Screening ECG abnormality documented by the investigator as medically significant
  • Inability to comply with protocol or study procedures.
  • Women who are pregnant or breastfeeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03587038
Other Study ID Numbers  ICMJE 9383
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oklahoma
Study Sponsor  ICMJE University of Oklahoma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Battiste, MD Principal Investigator
PRS Account University of Oklahoma
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP