Hepatocellular CarcinomaPhase 2NCT00746590
Study of Anti-tumour Effects and Safety of Prolarix™ in Hepatocellular Carcinoma
A Phase 2 study testing Prolarix (tretazicar co-administered with caricotamide) in people with Hepatocellular Carcinoma, run by BTG International Inc. at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Prolarix (tretazicar co-administered with caricotamide)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2008to Aug 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Prolarix (tretazicar co-administered with caricotamide)
- Keywords
- hepatocellular carcinoma, liver cancer, Prolarix, tretazicar, caricotamide, Phase 2, tumor, chemotherapy
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolarix (tretazicar co-administered with caricotamide)Drug
Also called Prolarix
Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Prolarix (tretazicar co-administered with caricotamide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Best Tumor Response Rate (Proportion of Subjects With Complete or Partial Response) as Defined by Modified RECIST
Measured: 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
Measured: Approximately 12 weeks or more after first treatment with Prolarix
Time to Tumour Progression
Measured: Every 3 weeks until progression
Post-treatment Changes in the Amount of Contrast-enhancing and Non-contrast-enhancing Tumour
Measured: Every 6 weeks until progression
Changes in Alpha Fetoprotein
Measured: Baseline, every 3 weeks until progression
Adverse Events
Measured: Until progression
Changes in Laboratory Measurements
Measured: Baseline and every 3 weeks until progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2009
- Study completionAug 2009
Why it stopped: Study terminated prematurely by sponsor for business reason. One patient was enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- BTG International Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Daugherty, MS, Study director, BTG International Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746590
- Sponsor's protocol ID
- PR003-CLN-pro001
- Status last verified
- Jul 2022
- First submitted
- 3 Sep 2008
- Last updated
- 21 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of the Anti-tumour Activity and Safety of Prolarix™ in Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT00746590
- Acronym / sponsor ID
- PR003-CLN-pro001
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, liver cancer, Prolarix, tretazicar, caricotamide, Phase 2, tumor, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated prematurely by sponsor for business reason. One patient was enrolled.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- BTG International Inc.University, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 4 Sep 2008 (estimated)
- Results
- Posted 9 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Prolarix (tretazicar co-administered with caricotamide) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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].
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolarix (tretazicar co-administered with caricotamide)Also: ProlarixProlarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression | Drug | 1 |
Primary outcome
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
6 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Daugherty, MS study director
BTG International Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prolarix (tretazicar co-administered with caricotamide) in people with Hepatocellular Carcinoma, run by BTG International Inc. at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.