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

This study has been terminated.
(Strategic reasons: Sponsor seeks oncology partner to explore Prolarix potential)
Sponsor:
Information provided by:
Protherics
ClinicalTrials.gov Identifier:
NCT00746590
First received: September 3, 2008
Last updated: September 16, 2009
Last verified: September 2009

September 3, 2008
September 16, 2009
September 2008
June 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00746590 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Time to tumour progression [ Time Frame: Every 3 weeks until progression ] [ Designated as safety issue: No ]
  • Post-treatment changes in the amount of contrast-enhancing and non-contrast-enhancing tumour [ Time Frame: Every 6 weeks until progression ] [ Designated as safety issue: No ]
  • Changes in alpha fetoprotein [ Time Frame: Baseline, every 3 weeks until progression ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Until progression ] [ Designated as safety issue: Yes ]
  • Changes in laboratory measurements [ Time Frame: Baseline and every 3 weeks until progression ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study of Anti-tumour Effects and Safety of Prolarix™ in Hepatocellular Carcinoma
A Phase 2 Study of the Anti-tumour Activity and Safety of Prolarix™ in Hepatocellular Carcinoma (HCC)

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinoma
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
Experimental: 1
Intervention: Drug: Prolarix (tretazicar co-administered with caricotamide)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
August 2009
June 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00746590
PR003-CLN-pro001
No
Claire Daugherty/ Clinical Project Manager, Protherics
Protherics
Not Provided
Study Director: Claire Daugherty, MS Protherics
Protherics
September 2009

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