Trial to Evaluate the Safety of TTAC-0001(Tanibirumab) in Recurrent Glioblastoma

NCT03033524 | Completed Phase 2 DMC

• 1 other identifier: PMC_TTAC-0001_02
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study Design - Multicenter, open-label, 3 arms, stepwise, phase Ⅱa clinical trial Study objective:

• To evaluate pharmacokinetic (PK) parameters of TTAC-0001 in patients with recurrent glioblastoma
• To evaluate pharmacodynamic (PD) parameters by clinical biomarker test Study Methodology Patients will be sequentially enrolled from the 1st arm. An enrollment criterion to the next arm is defined as no patients in the previous treatment arm showing grade ≥3 of hemangioma or other Dose Limiting Toxicities (DLT). A safety review committee (SRC) will convene to determine the patient's safety with a decision on enrollment into the next arm or change in dosing frequency of study drug in the above case. A patient who is withdrawn from the study before the completion of the 1st cycle can be replaced with another patient. Patients will be treated for up to 1 year, unless a cause for termination occurs, such as progression of disease (PD) or the withdrawal of consent.

Conditions

Recurrent Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Adverse events

  up to 1 year

Secondary Outcomes (4)

• PFS at 6-month time point

  6 months

• Objective response rate (ORR)

  up to 1 year

• Disease control rate(DCR)

  up to 1 year

• Overall survival(OS)

  up to 1 year

Other Outcomes (10)

• Area under the concentration-time curve (AUC)

  up to 1 year

• Maximum plasma concentration (Cmax)

  up to 1 year

• Minimum plasma concentration (Cmin)

  up to 1 year

Study Arms (3)

Cohort 1

EXPERIMENTAL

Patients will be treated with 8mg/kg of TTAC-0001 on day 1, day 8 and day 15 in every 4 weeks of cycle.

Drug: TTAC-0001

Cohort 2

EXPERIMENTAL

Patients will be treated with 12mg/kg of TTAC-0001 on day 1, day 8 and day 15 in every 4 weeks of cycle.

Drug: TTAC-0001

Cohort 3

EXPERIMENTAL

Patients will be treated with 12mg/kg of TTAC-0001 weekly in every 4 weeks of cycle.

Drug: TTAC-0001

Interventions

TTAC-0001 DRUG

Calculated amount of drug will be diluted with normal saline and administered intravenously.

Also known as: Tanibirumab

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both male and female patients ≥19 years old
• Diagnosed with primary glioblastoma by histopathological examination and confirmed recurrent glioblastoma by magnetic resonance imaging (MRI) scans after concomitant temozolomide chemotherapy with radiotherapy (CCRT). One previous recurrence/progression of glioblastoma with reintroduction/altered schedule of temozolomide is allowable.
• At least one confirmed measurable lesion or non measurable lesion by response assessment in neuro-oncology (RANO) criteria
• Karnofsky Performance Status (KPS) ≥ 80
• A person who satisfies the following criteria in hematologic, renal, and hepatic function tests
• At least 12 weeks of expected survival time
• Signed informed consent

You may not qualify if:

• Diagnosed with other malignant tumor within 2years
• Uncontrolled HT or seizure, class III or IV heart failure, oxygen dependent disease, active psychiatric disorder
• Not recovered grade 2 AE due to previous CCRT
• Major surgery or other investigational drug treatment within 4 weeks
• Pregnant/lactating female and female/male potential childbearing without contraception
• Severe drug hypersensitivity or hypersensitivity to a therapy similar to the study drug
• Expectation of poor compliance
• Previous therapy with VEGF targeted agent

Sponsors & Collaborators

• PharmAbcine: lead

MeSH Terms

Conditions

Glioblastoma

Interventions

olinvacimab

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 26, 2017
• Study Start: February 4, 2016
• Primary Completion: June 2, 2017
• Study Completion: June 2, 2017
• Last Updated: January 27, 2021

Record last verified: 2021-01