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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03856099




Registration number
NCT03856099
Ethics application status
Date submitted
21/02/2019
Date registered
27/02/2019

Titles & IDs
Public title
TTAC-0001 Phase II Trial With Recurrent Glioblastoma Progressed on Bevacizumab
Scientific title
A Multicenter, Open-Label, Phase ? Clinical Trial to Evaluate the Safety and Efficacy of TTAC-0001, a Fully Human Monoclonal Antibody in Patients With Recurrent Glioblastoma Progressed on Bevacizumab Including Therapy
Secondary ID [1] 0 0
PMC_TTAC-0001_03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent Glioblastoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TTAC-0001

Experimental: TTAC-0001 - TTAC-0001 with dose assigned to each dose group will be administered


Treatment: Drugs: TTAC-0001
* Investigational product (IP): TTAC-0001
* Treatment groups: 3 dose groups

* Dose group A : TTAC-0001 16 mg/kg on D1 and D15
* Dose group B : TTAC-0001 20 mg/kg on D1 and D15
* Dose group C : TTAC-0001 24 mg/kg on D1 and D15
* Cycle: 4 weeks (28 days per cycle)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Events
Timepoint [1] 0 0
until time of progressive disease or 1 year
Secondary outcome [1] 0 0
Progression free survival rate at 4 months
Timepoint [1] 0 0
at the end of 4 months
Secondary outcome [2] 0 0
Progression free survival rate at 6 months
Timepoint [2] 0 0
at the end of 6 months
Secondary outcome [3] 0 0
Progression free survival
Timepoint [3] 0 0
until time of progressive disease or time point of patients' death which come first assessed up to 1 year
Secondary outcome [4] 0 0
Overall survival
Timepoint [4] 0 0
until time point of patients' death up to 1 year
Secondary outcome [5] 0 0
Objective response rate
Timepoint [5] 0 0
At every 2nd cycles until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year (every cycle is 28 days)
Secondary outcome [6] 0 0
Disease control rate
Timepoint [6] 0 0
At every 2nd cycles until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year (every cycle is 28 days)

Eligibility
Key inclusion criteria
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

- 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
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

7) 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.

13) Has had a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/07/2022
Sample size
Target
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
PharmAbcine
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03856099