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

NCT00746590 | Terminated Phase 2 Results

• 1 other identifier: PR003-CLN-pro001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; liver cancer; Prolarix; tretazicar; caricotamide; Phase 2; tumor; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Overall Best Tumor Response Rate (Proportion of Subjects With Complete or Partial Response) as Defined by Modified RECIST

  every 6 weeks until progression

Secondary Outcomes (6)

• Disease Control Rate Defined as the Proportion of Subjects With Either Complete or Partial Response or Stable Disease

  Approximately 12 weeks or more after first treatment with Prolarix

• Time to Tumour Progression

  Every 3 weeks until progression

• Post-treatment Changes in the Amount of Contrast-enhancing and Non-contrast-enhancing Tumour

  Every 6 weeks until progression

• Changes in Alpha Fetoprotein

  Baseline, every 3 weeks until progression

• Adverse Events

  Until progression

Study Arms (1)

1

EXPERIMENTAL

Drug: Prolarix (tretazicar co-administered with caricotamide)

Interventions

Prolarix (tretazicar co-administered with caricotamide) DRUG

Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression

Also known as: Prolarix

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BTG International Inc.: lead

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Claire Daugherty
• Organization: BTG International Ltd.

claire.daugherty@btgplc.com

+1 801 556 8882

Study Officials

• Claire Daugherty, MS

  BTG International Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2008
• First Posted: September 4, 2008
• Study Start: September 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2009
• Last Updated: July 21, 2022
• Results First Posted: June 9, 2016

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)