TTAC-0001 Phase II Trial With Recurrent Glioblastoma Progressed on Bevacizumab

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    36
  • sponsor
    PharmAbcine
Updated on 26 September 2021
measurable disease
karnofsky performance status
neutrophil count
immunohistochemistry
bevacizumab
aptt
thromboplastin
glioblastoma multiforme
gliosarcoma

Summary

This is a phase II, open-Label clinical trial to evaluate the safety and efficacy of TTAC-0001 in patients with recurrent glioblastoma who was progressed on bevacizumab including therapy.

Details
Condition Recurrent Glioblastoma
Treatment TTAC-0001
Clinical Study IdentifierNCT03856099
SponsorPharmAbcine
Last Modified on26 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Provision of signed and dated informed consent prior to any study specific procedures, sampling or analyses
Aged at least 18 years old
Patients must have a histologically proven diagnosis of glioblastoma/gliosarcoma
Patients must have previous treatment including bevacizumab
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
At least one confirmed measurable lesion or non measurable lesion as determined by RANO criteria
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
Karnofsky Performance Status (KPS) 70
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
Hemoglobin 9.0 g/dL (2) Blood coagulation tests
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
Life expectancy of at least 12 weeks
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
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

Exclusion Criteria

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
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
) 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
) 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
) A known history of severe drug hypersensitivity or hypersensitivity to a
therapy similar to the study drug 8) Unable to participate in the trial
according to the investigator's decision. 9) Patient not eligible for
sequential MRI evaluations are not eligible for this study 10) Previous
therapy with VEGF-targeted agents except bevacizumab. 11) Known active
hepatitis B or hepatitis C infection 12) Has received a live vaccine within 30
days prior to enrollment. Seasonal flu vaccines that do not contain live virus
are permitted
) Has had a serious or non-healing wound, ulcer, or bone fracture within 28
days prior to enrollment
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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