A Study of CAN008 for Newly Diagnosed Glioblastoma Multiforme

• Status: Completed
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate CAN008 safety, tolerability, and pharmacokinetics (PK) of CAN008 when administered concurrent Plus Concomitant Temozolomide During and After Radiation Therapy in Patients with Newly Diagnosed Glioblastoma Multiforme.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CANbridge Life Sciences Ltd.

Criteria

Inclusion Criteria:

• Newly diagnosed and histologically confirmed glioblastoma multiforme

• Tumor must be surgically accessible and tissue must be available

• Age ≥ 20 years and < 75 years

• Life expectancy ≥ 6 months

• Baseline MRI images must be done within 2 days after surgery

• Patients must have a Karnofsky performances score ≥ 60 prior to treatment.

• Patients must not have received prior cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy for brain tumors.

• Adequate hematologic (absolute neutrophil count (ANC) ≥ 1.5x109/L, platelet count ≥ 100x109/L, hemoglobin ≥ 10 g/dL ), renal (creatinine ≤ 1.25xULN ), and hepatic function (total bilirubin ≤ 1.5xULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5xULN)

• Women with childbearing potential must have a negative serum pregnancy test less than 7 days prior to the first dose of study drug.

• Both men and women of reproductive potential agree to use approved contraception, such as condom and placement of an intrauterine device (IUD), during the study and until 3 months after the discontinuation of study treatment.

• Willing and able to comply with the protocol as judged by the investigator

• Patients must provide written consent

Exclusion Criteria:

• Any prior chemotherapy (including carmustine-containing wafers) or immunotherapy (including vaccine therapy )

• Any prior radiotherapy to the brain

• Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the cervix. Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial

• Any contraindication to TMZ listed in the local label

• Low-grade astrocytoma

• Unable to undergo MRI

• Past medical history of disease with poor prognosis according to the judgment of the Investigator

• HIV infection

• Patients with positive anti-HCV

• Patients with positive HbsAG who received any related treatment within the past 6 months

• Patients suffering from hereditary fructose intolerance (HFI).

• Patients receive any investigational agent(s) or device(s) within 30 days prior to entering the study

• Known coronary artery disease, significant arrhythmias or severe congestive heart failure