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A Study of the Safety and Pharmacokinetics of BRCX014 in Patients With Glioblastoma

NCT03687034 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2019-02-26

No results posted yet for this study

Summary

An Open-Label, Multi-Center Study to Assess the Safety and Pharmacokinetics of BRCX014 Combined with Standard-of-Care Treatment in Subjects with Glioblastoma

Conditions

Interventions

DRUG

Temozolomide

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).

DEVICE

Optune

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.

Sponsors & Collaborators

  • Leaf Vertical Inc.

    lead INDUSTRY

Principal Investigators

  • Nicholas Avgeropoulos, MD · Orlando Health / UF Health Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2019-09-30
Completion
2020-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03687034 on ClinicalTrials.gov