A Study of the Safety and Pharmacokinetics of BRCX014 in Patients With Glioblastoma
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|ClinicalTrials.gov Identifier: NCT03687034|
Recruitment Status : Not yet recruiting
First Posted : September 27, 2018
Last Update Posted : February 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Drug: Temozolomide Device: Optune||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This study consists of dose escalations that follow the standard 3+3 design, proceeding until the maximum tolerated dose is attained. The treatment period for patients in this study at each dose will be one year.|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of BRCX014 to Investigate Dose-Ranging Safety and Pharmacokinetics in Adults With Glioblastoma (GBM) and Non-Methylated MGMT Gene Status|
|Estimated Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||December 31, 2020|
Subjects will receive escalating doses of BRCX014 in conjunction with standard-of-care (SOC) treatment. For patients with GBM, following standard chemo-radiation treatment (radiation: 2 Gy per day for a total of 60 Gy; and temozolomide: 75 mg per square meter of body-surface area per day, seven days per week from the first to the last day of radiotherapy), SOC treatment comprises six cycles of adjuvant temozolomide (150 to 200 mg per square meter for five days during each 28-day cycle), with or without use of alternating electric field therapy (Optune device).
Standard-of-care chemotherapy for patients with glioblastoma includes concurrent radiation therapy (2 Gy per day for a total of 60 Gy) and temozolomide (75 mg per square meter of body- surface area per day, seven days per week from the first to the last day of radiotherapy), followed by six cycles of adjuvant temozolomide (150 to 200 mg per square meter for five days during each 28-day cycle).
Other Name: Temodar
Standard-of-care treatment for glioblastoma includes alternating electric-field therapy, or Optune, as a Category 1 treatment in conjunction with temozolomide after maximal safe resection and completion of radiation therapy.
Other Name: TTFields
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Through study completion, an average of one year ]The primary objective of this study is to evaluate the safety and tolerability of BRCX014 using clinical assessments and lab results.
- Maximum tolerated dose [ Time Frame: Through study completion, an average of one year ]A secondary objective of this study is to identify the maximum tolerated dose of BRCX014.
- Levels of metabolites [ Time Frame: Through study completion, an average of one year ]A secondary objective of this study is to perform pharmacokinetics analyses by measuring the plasma concentrations of BRCX014, temozolomide, and their major metabolites using lab results.
- Progression-free survival [ Time Frame: Through study completion, an average of one year ]A secondary objective of this study is to measure PFS using lab results and radiographic data.
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): NCT03687034
|Contact: Philip A Arlen, PhDfirstname.lastname@example.org|
|Contact: William Fisheremail@example.com|
|Principal Investigator:||Nicholas Avgeropoulos, MD||Orlando Health / UF Health Cancer Center|