KB004: This phase I trial is testing a new drug (KB004) in patients with recurrent glioblastomaA Phase I Safety and Bioimaging Trial of KB004 in Patients With Glioblastoma

Inclusion

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