Clinical Trial Details
Braintumor Website

[Information provided by:, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03374943 : A Trial of KB004 in Patients With Glioblastoma
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Adults (greater than or equal to 18 years of age) with histologically proven

- Evidence of progressive glioblastoma (if within 3 months of radiotherapy, then
progression outside of radiotherapy field is required)

- Measurable disease by RANO (Response Assessment in Neuro-Oncology Criteria)

- ECOG (Eastern Cooperative Oncology Group score) 0 to 1

- Expected survival more than 3 months

- Steroid dose less than 2.5 mg per day dexamethasone equivalents and stable or reducing
for 1 week prior to day 1

- Archived (formalin fixed paraffin embedded) tissue or frozen tumour tissue or consent
to obtain a fresh tumour biopsy at enrolment is required.

- Adequate organ function. Out of range values that are not clinically significant will
be permitted, except for the following laboratory parameters which must be within the
ranges specified

- Neutrophils greater than or equal to 1.5 x 109 per L

- Platelets greater than or equal to 100 x 109 per L

- International Normalised Ratio less than or equal to 1.4

- Serum Aspartate aminotransferase and Alanine aminotransferase less than or equal to
2.5 x ULN (upper limit of normal)

- Serum bilirubin less than or equal to 1.5 x ULN (upper limit of normal)

Exclusion Criteria:

- Evidence of infratentorial, extracranial or leptomeningeal disease

- More than one prior systemic therapy for progressive disease or prior Steriotactic
radiosurgery (SRS) to sites of GB (glioblastoma).

- Prior treatment with bevacizumab or gliadel wafers

- Evidence of current or prior intracranial hemorrhage

- Need for anti-platelet or anti-coagulant drugs

- Use of anti-cancer therapy including craniotomy, chemotherapy, immunotherapy,
radiotherapy, or any investigational therapy within 28 days prior to Study Day 1

- History of major immunologic reaction to any immunoglobulin G containing agent

- Medical conditions which place the subject at an unacceptably high risk

- Subject is pregnant, lactating or unwilling or unable to use adequate contraception
LinksPermanent Link to THIS page:      |      Link to official listing

Home | Brain Tumor Guide | FAQs | Find A Treatment
Noteworthy Treatments | News | Virtual Trial | Videos | Novocure Optune® | Newsletter
Donations | Brain Tumor Centers | Survivor Stories | Temodar®
Fundraising For Research | Unsubscribe | Contact Us

Copyright (c) 1993 - 2020 by:
The Musella Foundation For Brain Tumor Research & Information, Inc
1100 Peninsula Blvd
Hewlett, NY 11557