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Trial record 1 of 1 for:    NCT03033524
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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

Tracking Information
First Submitted Date  ICMJE January 9, 2017
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date January 26, 2017
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
Adverse events [ Time Frame: up to 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • PFS at 6-month time point [ Time Frame: 6 months ]
  • Objective response rate (ORR) [ Time Frame: up to 1 year ]
    The rate of complete response and partial response assessed according to RANO criteria.
  • 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.
  • Overall survival(OS) [ Time Frame: up to 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 25, 2017)
  • Area under the concentration-time curve (AUC) [ Time Frame: up to 1 year ]
    Pharmacokinetics profile
  • Maximum plasma concentration (Cmax) [ Time Frame: up to 1 year ]
    Pharmacokinetics profile
  • Minimum plasma concentration (Cmin) [ Time Frame: up to 1 year ]
    Pharmacokinetics profile
  • Clearance (CL) [ Time Frame: up to 1 year ]
    Pharmacokinetics profile
  • Volume of distribution (Vd) [ Time Frame: up to 1 year ]
    Pharmacokinetics profile
  • Half-life (t1/2) [ Time Frame: up to 1 year ]
    Pharmacokinetics profile
  • Angiogenic factors in serum or changes in concentration [ Time Frame: up to 1 year ]
    Pharmacodynamics profile
  • Perfusion parameter assessed by DCE-MRI [ Time Frame: every 2 cycles(each cycle is 4 weeks), up to 1year ]
    Pharmacodynamics profile
  • Expression of angiogenic factors in endothelial cells [ Time Frame: At screening ]
    Analyzed by IHC of tumor tissue
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Trial to Evaluate the Safety of TTAC-0001(Tanibirumab) in Recurrent Glioblastoma
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Glioblastoma
Intervention  ICMJE Drug: TTAC-0001
Calculated amount of drug will be diluted with normal saline and administered intravenously.
Other Name: Tanibirumab
Study Arms  ICMJE
  • 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.
    Intervention: Drug: TTAC-0001
  • 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.
    Intervention: Drug: TTAC-0001
  • Experimental: Cohort 3
    Patients will be treated with 12mg/kg of TTAC-0001 weekly in every 4 weeks of cycle.
    Intervention: Drug: TTAC-0001
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: January 25, 2017)
12
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2017
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03033524
Other Study ID Numbers  ICMJE PMC_TTAC-0001_02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party PharmAbcine
Study Sponsor  ICMJE PharmAbcine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account PharmAbcine
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP