Quality of LifePhase 2/3NCT01747642
Safety and Efficacy of Oncoxin Plus Surafineb in Hepatocellular Carcinoma
A Phase 2/3 study testing Oncoxin and Suranix in people with Quality of Life, run by Clinical Research Organization, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
Oncoxin in combination with Surafenib is safe and results in improved survival in patients with hepatocellular carcinoma (HCC) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Quality of Life
- What is being tested?
- Oncoxin and Suranix
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBangladesh
- Study dates
- Dec 2012to Jun 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with HCC irrespective of etiology, age, gender and status of underlying liver disease.
- Patients with HCC who are not suitable candidates for established modalities of treatment i.e. surgery and/or chemotherapy.
- Patients with HCC who have evidence of tumor metastasis
- Patients with HCC who are voluntarily unwilling to take established modalities of treatment i.e. surgery and/or chemotherapy.
- Patients with HCC in whom all possible treatment options have been exhausted.
Who cannot join
- Patients with HCC who are suitable candidates for established modalities of treatment i.e. surgery and/or chemotherapy.
- Patients with HCC who have no evidence of tumor metastasis
- Patients with HCC who are willing to take established modalities of treatment i.e. surgery and/or chemotherapy.
- Patients with HCC who are voluntarily unwilling to be included in the trial
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site, 1 recruiting
- Recruiting
Farabi General Hospital
Dhaka, 1215
Mamun A Mahtab, MD, FACG, +8801711567275, shwapnil@agni.com
Helal Uddin, BSc, +880-1819251514, crobangladesh@gmail.com
About this study
Official title: Study to Evaluate Safety and Therapeutic Efficacy of a Combination Therapy of 'Oncoxin', a Nutritional Supplement and Surafenib, a Multikinase Inhibitor in Patients With Hepatocellular Carcinoma
Oncoxin in combination with Surafenib is safe and results in improved survival in patients with hepatocellular carcinoma (HCC)
Read the detailed description
To assess therapeutic efficacy and safety of Oncoxin plus Surafenib in hepatocellular carcinoma
To see if there is reduction in serum alpha fetoprotein level in hepatocellular carcinoma patients after administration of Oncoxin plus Surafenib
To see if there is reduction tumor size and or number in hepatocellular carcinoma patients after administration of Oncoxin plus Surafenib
To see if there is improvement of quality of life in hepatocellular carcinoma patients after administration of Oncoxin plus Surafenib
To see if there is improved survival in hepatocellular carcinoma patients after administration of Oncoxin plus Surafenib
- Conditions
- Quality of Life
- Being tested
- Oncoxin, Suranix
- Keywords
- Hepatocellular carcinoma, Oncoxin, Surafenib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OncoxinDietary supplement
Syp Oncoxin 25 ml bd and Cap. Oncoxin bd for 180 days
SuranixDrug
Also called Nexavar, Suranib
Tab Suranix 200 mg 2 tab bd and Syp Oncoxin 25 ml bd and Cap. Oncoxin bd for 180 days
| Study group | Role | What they receive |
|---|---|---|
| Oncoxin | Active comparator | Syp Oncoxin 25 ml bd and Cap. Oncoxin bd orally for 180 days Receives: Dietary Supplement: Oncoxin |
| Oncoxin & Suranix | Active comparator | Tab Suranix 200 mg 2 tab bd and Syp Oncoxin 25 ml bd and Cap. Oncoxin bd orally for 180 days Receives: Dietary Supplement: Oncoxin; Drug: Suranix |
| Supportive treatment | No intervention | Only supportive treatment. No chemotherapy, radoiotherapy, ablation or surgical intervention will be carried out. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who have prolonged survival
To study the number of participants who have prolonged survival in months after receiving Oncoxin plus Surafenib for 24 weeks
Measured: 24 weeks
Secondary outcomes (1)
Reduction in serum alpha-fetoprotein level and decrease in tumor size
To see whether Oncoxin plus Surafenib results in reduction in serum alpha-fetoprotein level in ng/ml and decrease in tumor size in mm in hepatocellular carcinoma patients off treatment for 24 weeks, after receiving Oncoxin plus Surafenib for 24 weeks.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2013 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Research Organization, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mamun A Mahtab, MD, FACG, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747642
- Sponsor's protocol ID
- OP2
- Status last verified
- Dec 2012
- First submitted
- 7 Dec 2012
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate Safety and Therapeutic Efficacy of a Combination Therapy of 'Oncoxin', a Nutritional Supplement and Surafenib, a Multikinase Inhibitor in Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01747642
- Acronym / sponsor ID
- OP2
- Conditions
- Quality of Life
- Keywords
- Hepatocellular carcinoma, Oncoxin, Surafenib
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Clinical Research Organization, Dhaka, BangladeshUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 12 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oncoxin in combination with Surafenib is safe and results in improved survival in patients with hepatocellular carcinoma (HCC)
Detailed description
To assess therapeutic efficacy and safety of Oncoxin plus Surafenib in hepatocellular carcinoma
To see if there is reduction in serum alpha fetoprotein level in hepatocellular carcinoma patients after administration of Oncoxin plus Surafenib
To see if there is reduction tumor size and or number in hepatocellular carcinoma patients after administration of Oncoxin plus Surafenib
To see if there is improvement of quality of life in hepatocellular carcinoma patients after administration of Oncoxin plus Surafenib
To see if there is improved survival in hepatocellular carcinoma patients after administration of Oncoxin plus Surafenib
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oncoxin | Active comparator | Dietary Supplement: OncoxinSyp Oncoxin 25 ml bd and Cap. Oncoxin bd orally for 180 days |
| Oncoxin & Suranix | Active comparator | Dietary Supplement: Oncoxin, Drug: SuranixTab Suranix 200 mg 2 tab bd and Syp Oncoxin 25 ml bd and Cap. Oncoxin bd orally for 180 days |
| Supportive treatment | No intervention | –Only supportive treatment. No chemotherapy, radoiotherapy, ablation or surgical intervention will be carried out. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with HCC irrespective of etiology, age, gender and status of underlying liver disease.
- Patients with HCC who are not suitable candidates for established modalities of treatment i.e. surgery and/or chemotherapy.
- Patients with HCC who have evidence of tumor metastasis
- Patients with HCC who are voluntarily unwilling to take established modalities of treatment i.e. surgery and/or chemotherapy.
- Patients with HCC in whom all possible treatment options have been exhausted.
Key exclusion criteria (4 listed)
- Patients with HCC who are suitable candidates for established modalities of treatment i.e. surgery and/or chemotherapy.
- Patients with HCC who have no evidence of tumor metastasis
- Patients with HCC who are willing to take established modalities of treatment i.e. surgery and/or chemotherapy.
- Patients with HCC who are voluntarily unwilling to be included in the trial
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 |
|---|---|---|
| OncoxinSyp Oncoxin 25 ml bd and Cap. Oncoxin bd for 180 days | Dietary supplement | Oncoxin, Oncoxin & Suranix |
| SuranixAlso: Nexavar, SuranibTab Suranix 200 mg 2 tab bd and Syp Oncoxin 25 ml bd and Cap. Oncoxin bd for 180 days | Drug | Oncoxin & Suranix |
Primary outcome
Number of patients who have prolonged survival
Time frame: 24 weeks
To study the number of participants who have prolonged survival in months after receiving Oncoxin plus Surafenib for 24 weeks
1 secondary outcome
Reduction in serum alpha-fetoprotein level and decrease in tumor size
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2012.
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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.
Mamun A Mahtab, MD, FACG principal investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oncoxin and Suranix in people with Quality of Life, run by Clinical Research Organization, Dhaka, Bangladesh at 1 site in Bangladesh.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Dec 2012. 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 Bangladesh. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who have prolonged survival (time frame: 24 weeks). 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 12 Dec 2012.