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Study of Anti-tumour Effects and Safety of Prolarix™ in Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00746590
Recruitment Status : Terminated (Study terminated prematurely by sponsor for business reason. One patient was enrolled.)
First Posted : September 4, 2008
Results First Posted : June 9, 2016
Last Update Posted : June 9, 2016
Information provided by (Responsible Party):
BTG International Inc.

Tracking Information
First Submitted Date  ICMJE September 3, 2008
First Posted Date  ICMJE September 4, 2008
Results First Submitted Date  ICMJE May 3, 2016
Results First Posted Date  ICMJE June 9, 2016
Last Update Posted Date June 9, 2016
Study Start Date  ICMJE September 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2008)
Overall Best Tumor Response Rate (Proportion of Subjects With Complete or Partial Response) as Defined by Modified RECIST [ Time Frame: every 6 weeks until progression ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2008)
  • Disease Control Rate Defined as the Proportion of Subjects With Either Complete or Partial Response or Stable Disease [ Time Frame: Approximately 12 weeks or more after first treatment with Prolarix ]
  • Time to Tumour Progression [ Time Frame: Every 3 weeks until progression ]
  • Post-treatment Changes in the Amount of Contrast-enhancing and Non-contrast-enhancing Tumour [ Time Frame: Every 6 weeks until progression ]
  • Changes in Alpha Fetoprotein [ Time Frame: Baseline, every 3 weeks until progression ]
  • Adverse Events [ Time Frame: Until progression ]
  • Changes in Laboratory Measurements [ Time Frame: Baseline and every 3 weeks until progression ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Study of Anti-tumour Effects and Safety of Prolarix™ in Hepatocellular Carcinoma
Official Title  ICMJE A Phase 2 Study of the Anti-tumour Activity and Safety of Prolarix™ in Hepatocellular Carcinoma (HCC)
Brief Summary

This an open-label study designed to evaluate the anti-tumour activity and safety of Prolarix in subjects with advanced hepatocellular carcinoma.

Prolarix is a chemotherapy comprised of tretazicar as prodrug and caricotamide as co-substrate for the endogenous enzyme, NQO2.

Detailed Description

The primary objective of this study is to evaluate the anti-tumour effects of treatment with Prolarix in subjects with advanced HCC (Child-Pugh A and B only).

All subjects will receive an IV infusion of Prolarix once every 21 days until disease progression is observed.

Subjects will have CT scans for tumour measurements before starting treatment with Prolarix and every 6 weeks until disease progression.

Subjects will undergo evaluation for safety (adverse events, vital signs, clinical laboratory measurements, weight, ECG) every 21 days until disease progression.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatocellular Carcinoma
Intervention  ICMJE Drug: Prolarix (tretazicar co-administered with caricotamide)
Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
Other Name: Prolarix
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Prolarix (tretazicar co-administered with caricotamide)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 3, 2016)
Original Estimated Enrollment  ICMJE
 (submitted: September 3, 2008)
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject must be at least 18 years of age.
  • Subject must have a histologic or cytologic diagnosis of HCC and be considered unsuitable for resection or other potentially curative options (eg, liver transplant, curative radiofrequency ablation).
  • Subject must have a measurable lesion by RECIST on CT scan in at least one site which has not received radiation or any other local therapy [eg, transcatheter arterial chemoembolisation (TACE), radiofrequency ablation, local injection]. (Note: Subjects who have received local therapies will be allowed to participate, provided that they have a target lesion which has not been subjected to local therapy. Subjects who have received TACE must have a target lesion outside of the vascular territory subjected to chemoembolisation.)
  • Subject has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
  • Subject has had no other active malignancy within the past three years [other than non melanomatous skin cancer or carcinoma in situ (CIS) of the breast, bladder, or uterine cervix. Subjects with Ta (non-invasive papillary carcinoma) or Tis (sessile carcinoma in situ) bladder cancer are allowed].
  • Subject has a minimum life expectancy of at least three months as determined by the investigator.
  • Subject has adequate bone marrow function (ie, haemoglobin ≥9 g/dL, granulocytes ≥1500/mm3, platelets ≥75,000/mm3).
  • Prothrombin time (PT)-international normalised ratio (INR) ≤2.3 or PT ≤6 seconds above control. (Note: Subjects who are being therapeutically anticoagulated with an agent such as warfarin or heparin will be allowed to participate provided that their INR is between 2.0 and 3.0.
  • Subject has adequate renal function (ie, serum creatinine is normal or calculated creatinine clearance is ≥60 mL/min).
  • Subject has adequate hepatic function (ie, bilirubin ≤2x upper limit of normal (ULN); AST ALT, and alkaline phosphatase ≤5xULN). (Also see exclusion for Child-Pugh class C below).
  • Male subjects and females of childbearing potential must agree to use an adequate method of contraception from the time of initiation of treatment through study participation and for 3 months after release from the study.
  • Subject is able to give informed consent.

Exclusion Criteria:

  • Any prior or current systemic pharmacotherapy for HCC (cytotoxic, targeted or biologic). (Note: TACE is not considered to be systemic pharmacotherapy for the purpose of this study).
  • Subject has an absolute contraindication to receiving CT contrast media. (Note: Subjects with a history of minor contrast reactions may be pre-medicated prior to contrast administration in accordance with local or institutional practice).
  • Subject has Child-Pugh Class C hepatic impairment.
  • Subject has received an investigational drug within 30 days of enrolment in the study.
  • Females of childbearing potential unless using adequate contraception.
  • Pregnant or lactating females.
  • Major variceal bleeding in the last 30 days.
  • Subjects with a known history of human immunodeficiency virus (HIV) infection.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 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 Belgium
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00746590
Other Study ID Numbers  ICMJE PR003-CLN-pro001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party BTG International Inc.
Study Sponsor  ICMJE BTG International Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Claire Daugherty, MS BTG International Inc.
PRS Account BTG International Inc.
Verification Date May 2016

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