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

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ClinicalTrials.gov Identifier: NCT03033524
Recruitment Status : Unknown
Verified January 2017 by PharmAbcine.
Recruitment status was:  Active, not recruiting
First Posted : January 26, 2017
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
PharmAbcine

Brief Summary:

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

Study objective:

  1. Primary - To evaluate the safety of TTAC-0001 in patients with recurrent glioblastoma.
  2. Secondary - To determine the efficacy of TTAC-0001 in patients with recurrent glioblastoma.
  3. Exploratory

    • 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A patient who is withdrawn from the study before the completion of the 1st cycle can be replaced with another patient.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.


Condition or disease Intervention/treatment Phase
Recurrent Glioblastoma Drug: TTAC-0001 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, 3-Arm, Open-Label, Phase Ⅱa Clinical Trial to Evaluate the Safety and Efficacy of TTAC-0001, a Fully Human Monoclonal Antibody in Patients With Recurrent Glioblastoma
Study Start Date : February 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1
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
Calculated amount of drug will be diluted with normal saline and administered intravenously.
Other Name: Tanibirumab

Experimental: Cohort 2
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
Calculated amount of drug will be diluted with normal saline and administered intravenously.
Other Name: Tanibirumab

Experimental: Cohort 3
Patients will be treated with 12mg/kg of TTAC-0001 weekly in every 4 weeks of cycle.
Drug: TTAC-0001
Calculated amount of drug will be diluted with normal saline and administered intravenously.
Other Name: Tanibirumab




Primary Outcome Measures :
  1. Adverse events [ Time Frame: up to 1 year ]

Secondary Outcome Measures :
  1. PFS at 6-month time point [ Time Frame: 6 months ]
  2. Objective response rate (ORR) [ Time Frame: up to 1 year ]
    The rate of complete response and partial response assessed according to RANO criteria.

  3. Disease control rate(DCR) [ Time Frame: up to 1 year ]
    The rate of complete response(CR), partial response(PR) and stable disease(SD) assessed according to RANO criteria.

  4. Overall survival(OS) [ Time Frame: up to 1 year ]

Other Outcome Measures:
  1. Area under the concentration-time curve (AUC) [ Time Frame: up to 1 year ]
    Pharmacokinetics profile

  2. Maximum plasma concentration (Cmax) [ Time Frame: up to 1 year ]
    Pharmacokinetics profile

  3. Minimum plasma concentration (Cmin) [ Time Frame: up to 1 year ]
    Pharmacokinetics profile

  4. Clearance (CL) [ Time Frame: up to 1 year ]
    Pharmacokinetics profile

  5. Volume of distribution (Vd) [ Time Frame: up to 1 year ]
    Pharmacokinetics profile

  6. Half-life (t1/2) [ Time Frame: up to 1 year ]
    Pharmacokinetics profile

  7. Angiogenic factors in serum or changes in concentration [ Time Frame: up to 1 year ]
    Pharmacodynamics profile

  8. Perfusion parameter assessed by DCE-MRI [ Time Frame: every 2 cycles(each cycle is 4 weeks), up to 1year ]
    Pharmacodynamics profile

  9. Expression of angiogenic factors in endothelial cells [ Time Frame: At screening ]
    Analyzed by IHC of tumor tissue

  10. Immunogenicity [ Time Frame: Day 1 of every cycle(each cycle is 4 weeks), up to 1 year ]
    Anti-drug (TTAC-0001) antibody (ADA) test for evaluation of immunogenicity



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
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Responsible Party: PharmAbcine
ClinicalTrials.gov Identifier: NCT03033524    
Other Study ID Numbers: PMC_TTAC-0001_02
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue