Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
PharmAbcine
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Provision of signed and dated informed consent prior to any study specific procedures, sampling or analyses.
2. Aged at least 18 years old
3. Patients must have a histologically proven diagnosis of glioblastoma/gliosarcoma
4. Patients must have previous treatment including bevacizumab
5. Patients must have a radiological diagnosis of recurrent/relapsed or progressive glioblastoma/gliosarcoma after bevacizumab including therapy according to response assessment in neuro-oncology (RANO) criteria
6. At least one confirmed measurable lesion or non measurable lesion as determined by RANO criteria
7. Patients must undergo IDH1 mutational testing on a tumor specimen before entering the study. Immunohistochemistry (IHC) is sufficient for enrollment, although DNA sequencing may also be performed as per local institutional guidelines. Patients are eligible regardless of their tumor status.
8. Karnofsky Performance Status (KPS) ≥ 70
9. A person who satisfies the following criteria in hematologic, renal, and hepatic function tests (1) Hematologic tests - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L - Platelets ≥ 75 x 109/L
\- Prothrombin time (PT) ≤ 1.5 x Upper limit of normal (ULN)
\- Activated partial thromboplastin Time (aPTT) ≤ 1.5 x ULN (3) Hepatic function tests
* Total bilirubin ≤ 1.5 x ULN
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x ULN (4) Renal function test
* Creatinine clearance (CrCl) ≥ 30 mL/minute calculated by Cockcroft-Gault formula
10. Life expectancy of at least 12 weeks
11. Females of child bearing potential must have a negative pregnancy test during screening and must not be breastfeeding or intending to become pregnant during the study.
12. Male patients with female partners of child-bearing potential must be willing to use two forms of acceptable contraception, including one barrier method, during their participation in this study and for 16 weeks following the last dose of the study. Refer to section 10.5.1 Restrictions, permitted methods of contraception and definitions.
You may not be if
1. Diagnosed with malignant tumors, except basal cell carcinoma, cutaneous squamous cell carcinoma, and noninvasive uterine cervical cancer treated within 2 years prior to receiving the first dose of treatment.
2. The following concomitant diseases:
(1) Uncontrolled hypertension (systolic blood pressure \[SBP\] \> 150 or diastolic blood pressure \[DBP\] \> 90 mmHg) (2) Uncontrolled seizures (3) Class III or IV heart failure according to New York Heart Association (NYHA) classification (4) Oxygen-dependent chronic disease (5) Active psychiatric disorder (schizophrenia, major depressive disorder, bipolar disorder etc.). Treated depression with ongoing antidepressant medication is not an exclusion.
3\) Not recovered from AEs \< National Cancer Institute -Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade 2 caused by CCRT 4) Treatment with bevacizumab including therapy 2 weeks prior to receiving the first dose of treatment.
5\) Undergone major surgery requiring general anesthesia or a respiratory assistance device within 4 weeks prior to the baseline visit (within 2 weeks for video-assisted thoracoscopic surgery \[VATS\] or open-and-closed \[ONC\] surgery) 6) Treated with other investigational products within 4 weeks prior to the patient receiving the first dose of treatment.
13\) Has had a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment
Clareo Health | TTAC-0001 Phase II Trial With Recurrent Glioblastoma Progressed on Bevacizumab
