Safety and Efficacy of Oncoxin Plus Surafineb in Hepatocellular Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Clinical Research Organization, Dhaka, Bangladesh
Sponsor:
Information provided by (Responsible Party):
Clinical Research Organization, Dhaka, Bangladesh
ClinicalTrials.gov Identifier:
NCT01747642
First received: December 7, 2012
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

Oncoxin in combination with Surafenib is safe and results in improved survival in patients with hepatocellular carcinoma (HCC)


Condition Intervention Phase
Quality of Life
Dietary Supplement: Oncoxin
Drug: Suranix
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Clinical Research Organization, Dhaka, Bangladesh:

Primary Outcome Measures:
  • Number of patients who have prolonged survival [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    To study the number of participants who have prolonged survival in months after receiving Oncoxin plus Surafenib for 24 weeks


Secondary Outcome Measures:
  • Reduction in serum alpha-fetoprotein level and decrease in tumor size [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 60
Study Start Date: December 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oncoxin
Syp Oncoxin 25 ml bd and Cap. Oncoxin bd orally for 180 days
Dietary Supplement: Oncoxin
Syp Oncoxin 25 ml bd and Cap. Oncoxin bd for 180 days
Active Comparator: Oncoxin & Suranix
Tab Suranix 200 mg 2 tab bd and Syp Oncoxin 25 ml bd and Cap. Oncoxin bd orally for 180 days
Dietary Supplement: Oncoxin
Syp Oncoxin 25 ml bd and Cap. Oncoxin bd for 180 days
Drug: Suranix
Tab Suranix 200 mg 2 tab bd and Syp Oncoxin 25 ml bd and Cap. Oncoxin bd for 180 days
Other Names:
  • Nexavar
  • Suranib
No Intervention: Supportive treatment
Only supportive treatment. No chemotherapy, radoiotherapy, ablation or surgical intervention will be carried out.

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747642

Locations
Bangladesh
Farabi General Hospital Recruiting
Dhaka, Bangladesh, 1215
Contact: Mamun A Mahtab, MD, FACG    +8801711567275    shwapnil@agni.com   
Contact: Helal Uddin, BSc    +880-1819251514    crobangladesh@gmail.com   
Principal Investigator: Mamun A Mahtab, MD, FACG         
Sub-Investigator: Lovely Begum, BPharm         
Sponsors and Collaborators
Clinical Research Organization, Dhaka, Bangladesh
Investigators
Principal Investigator: Mamun A Mahtab, MD, FACG Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  More Information

Additional Information:
No publications provided

Responsible Party: Clinical Research Organization, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT01747642     History of Changes
Other Study ID Numbers: OP2
Study First Received: December 7, 2012
Last Updated: December 11, 2012
Health Authority: Bangladesh: Directorate of Drug Administration

Keywords provided by Clinical Research Organization, Dhaka, Bangladesh:
Hepatocellular carcinoma
Oncoxin
Surafenib

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 22, 2014