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Trial record 1 of 1 for:    NCT01387555
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A Phase 2b Study of Modified Vaccinia Virus to Treat Patients Advanced Liver Cancer Who Failed Sorafenib (TRAVERSE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Jennerex Biotherapeutics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Jennerex Biotherapeutics
ClinicalTrials.gov Identifier:
NCT01387555
First received: June 27, 2011
Last updated: January 13, 2014
Last verified: July 2012

June 27, 2011
January 13, 2014
August 2011
October 2013   (final data collection date for primary outcome measure)
Survival [ Time Frame: CT scan every six weeks until progression or death, assessed up to 21 months ] [ Designated as safety issue: No ]
Determine overall survival for patients receiving JX-594 plus best supportive care (Arm A) compared with those patients receiving best supportive care (Arm B) in patients with advanced hepatocellular carcinoma (HCC) who have failed sorafenib treatment.
Survival [ Time Frame: CT scan every six weeks until progression or death, assessed up to 21 months ] [ Designated as safety issue: No ]
Determine overall survival for patients receiving JX-594 plus best supportive care (Arm A) compared with those patients receiving placebo plus best supportive care (Arm B) in patients with advanced hepatocellular carcinoma (HCC) who have failed sorafenib treatment.
Complete list of historical versions of study NCT01387555 on ClinicalTrials.gov Archive Site
  • Time to Tumor Progression [ Time Frame: CT scan every six weeks until progression or death, assessed up to 21 months ] [ Designated as safety issue: No ]
    Determine time-to-tumor-progression (TTP) for Arm A compared with Arm B based on mRECIST for HCC.
  • Quality of Life [ Time Frame: assessed up to 21 months (average) ] [ Designated as safety issue: No ]
    Determine the Quality of Life (QoL) of patients treated in Arm A compared with Arm B.
  • Tumor Response [ Time Frame: CT scan every 6 weeks until progression or death, assessed up to 21 months (average) ] [ Designated as safety issue: No ]
    Determine tumor response based on mRECIST for HCC of Arm A versus Arm B
  • Safety profile of JX594 [ Time Frame: assessed up to 21 months (average) ] [ Designated as safety issue: Yes ]
    Safety will be assessed by the number of adverse events (AEs) and serious adverse events (SAEs)
  • Time-to-symptomatic-progression [ Time Frame: assessed up to 21 months (average) ] [ Designated as safety issue: No ]
    Determine time to progression of Arm A compared to Arm B.
  • Time to Tumor Progression [ Time Frame: CT scan every six weeks until progression or death, assessed up to 21 months ] [ Designated as safety issue: No ]
    Determine time-to-tumor-progression (TTP) for Arm A compared with Arm B based on mRECIST for HCC.
  • Quality of Life [ Time Frame: assessed up to 21 months (average) ] [ Designated as safety issue: No ]
    Determine the Quality of Life (QoL) of patients treated in Arm A compared with Arm B.
  • Tumor Response [ Time Frame: CT scan every 6 weeks until progression or death, assessed up to 21 months (average) ] [ Designated as safety issue: No ]
    Determine tumor response based on mRECIST for HCC of Arm A verus Arm B
  • Safety profile of JX594 [ Time Frame: assessed up to 21 months (average) ] [ Designated as safety issue: Yes ]
    Safety will be assessed by the number of adverse events (AEs) and serious adverse events (SAEs)
  • Time-to-symptomatic-progression [ Time Frame: assessed up to 21 months (average) ] [ Designated as safety issue: No ]
    Determine time to progression of Arm A compared to Arm B.
Not Provided
Not Provided
 
A Phase 2b Study of Modified Vaccinia Virus to Treat Patients Advanced Liver Cancer Who Failed Sorafenib
A Phase 2b Randomized Trial of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) Plus Best Supportive Care Versus Best Supportive Care in Patients With Advanced Hepatocellular Carcinoma Who Have Failed Sorafenib Treatment

This study is to determine whether JX-594 (Pexa-Vec) plus best supportive care is more effective in improving survival than best supportive care in patients with advanced Hepatocellular Carcinoma (HCC) who have failed sorafenib.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatocellular Carcinoma
  • Liver Cancer
  • HCC
  • Biological: JX-594 recombinant vaccina GM-CSF
    Patients will be randomised 2:1 to Arm A or Arm B and will receive 6 treatments on days 1, 8, 22, week 6, week 12, and week 18 plus best supportive care as needed.
  • Other: Best Supportive Care
    Patients will be randomised 2:1 to Arm A or Arm B and will receive best supportive care as needed.
  • Experimental: Arm A
    Patients on Arm A will receive 1 e9 pfu (plaque forming units) total dose of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) on each of six (6) treatments over 18 weeks.
    Intervention: Biological: JX-594 recombinant vaccina GM-CSF
  • Arm B
    Patients on the control arm (Arm B) will have best supportive care over 18 weeks.
    Intervention: Other: Best Supportive Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
129
October 2014
October 2013   (final data collection date for primary outcome measure)

KEY Inclusion Criteria:

  • Diagnosis of primary HCC by tissue biopsy (histological/cytological diagnosis), or clinical diagnosis
  • Previously treated with sorafenib for ≥ 14 days and has discontinued sorafenib treatment at least 14 days prior to randomization due to either intolerance or radiographic progression NOTE: Sorafenib is NOT required to be the most recent treatment received for HCC
  • ECOG performance status 0, 1 or 2
  • Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites
  • Hematocrit ≥30% or Hemoglobin ≥10 g/dL
  • Tumor status: Measurable viable tumor in the liver and injectable under imaging-guidance; At least one tumor in the liver that has not received prior local-regional treatment OR that has exhibited >25% growth in viable tumor size since prior local-regional treatment.

KEY Exclusion Criteria:

  • Received sorafenib within 14 days prior to randomization
  • Received systemic anti-cancer therapy other than sorafenib within 28 days of randomization
  • Prior treatment with JX-594
  • Platelet count < 50,000 PLT/ mm3
  • Total white blood cell count < 2,000 cells/mm3
  • Prior or planned organ transplant
  • Known significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication
  • Severe or unstable cardiac disease
  • Viable CNS malignancy associated with clinical symptoms
  • Pregnant or nursing an infant
  • History of inflammatory skin condition (e.g., eczema requiring previous treatment, atopic dermatitis)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   France,   Germany,   Hong Kong,   Korea, Republic of,   Taiwan
 
NCT01387555
JX594-HEP018
Yes
Jennerex Biotherapeutics
Jennerex Biotherapeutics
Not Provided
Study Director: James Burke, MD Jennerex Biotherapeutics
Jennerex Biotherapeutics
July 2012

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