Trial record 2 of 12 for:    Kansas HCC sorafenib

Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00692770
First received: June 5, 2008
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

To evaluate efficacy and safety of sorafenib versus placebo in the adjuvant treatment of Hepatocellular Carcinoma (HCC) after potentially curative treatment (surgical resection or local ablation).


Condition Intervention Phase
Carcinoma, Hepatocellular
Drug: Nexavar (Sorafenib, BAY43-9006)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Double-blind, Placebo-controlled Study of Sorafenib as Adjuvant Treatment for Hepatocellular Carcinoma After Surgical Resection or Local Ablation.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Recurrence Free Survival [ Time Frame: approximately 70 months from first patient first visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to recurrence [ Time Frame: approximately 70 months from first patient first visit ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: approximately 140 months from first patient first visit ] [ Designated as safety issue: No ]
  • Patient-Reported Outcome (PRO) as assessed by FACT-Hep and EQ-5D questionnaire. [ Time Frame: approximately 70 months from first patient first visit ] [ Designated as safety issue: No ]
  • Evaluation of biomarkers. [ Time Frame: approximately 70 months from first patient first visit ] [ Designated as safety issue: No ]

Enrollment: 1114
Study Start Date: August 2008
Estimated Study Completion Date: March 2020
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Nexavar (Sorafenib, BAY43-9006)
400mg (2 x 200mg tablets) orally, twice a day, continuously , until disease recurrence or unacceptable toxicity or other criteria for withdrawal are met.
Placebo Comparator: Arm 2 Drug: Placebo
400mg (2 x 200mg tablets) orally, twice a day, continuously , until disease recurrence or unacceptable toxicity or other criteria for withdrawal are met.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who have undergone surgical resection or local ablation (PEI or percutaneous or intraoperative RFA) for treatment of HCC with curative intent within 4 months from staging to potentially curative treatment. A maximum of 2 local ablation courses may be administered during this time period.
  • At least 3 weeks (21 days) but no more than 7 weeks (49 days), from resection or last local ablation course, to CT/MRI scan date
  • Male or female subjects >/= 18 years of age
  • Confirmation of CR (absence of residual tumor after curative treatment), on the eligibility scan by independent radiological review.
  • For subjects undergoing surgical resection pathology proven complete removal of tumor.
  • Intermediate or High Risk of recurrence as assessed by tumor characteristics.
  • Child-Pugh score 5 -7 points. A Child-Pugh score of 7 points is allowed only in the absence of ascites.
  • ECOG Performance Status of 0.
  • Adequate bone marrow, liver and renal function

Exclusion Criteria:

  • Recurrent HCC
  • Child-Pugh score 7 points with presence of ascites.
  • Low risk of recurrence after curative treatment
  • History of cardiovascular disease
  • History of HIV infection
  • Active clinically serious infections (> grade 2 NCI-CTCAE version 3.0)
  • Subjects with seizure disorder requiring medication (such as steroids or anti-epileptics)
  • Subjects with evidence or history of bleeding diathesis
  • Subjects undergoing renal dialysis
  • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry as defined by the signing of informed consent..
  • Uncontrolled ascites (defined as not easily controlled with diuretic treatment)
  • Encephalopathy
  • History of GI bleeding within 30 days of randomization.
  • Subjects with a history of esophageal varices bleeding which has not been followed by effective therapy and/or treatment to prevent bleeding recurrence.
  • Prior anti cancer therapy for treatment of HCC (including sorafenib or any other molecular therapy) is excluded.
  • Major surgery within 4 weeks of start of study as defined by the signing of informed consent, except for surgical resection or local ablation of HCC.
  • Investigational drug therapy outside of this trial during or within 4 weeks of study entry, as defined by the signing of informed consent.
  • Liver transplantation, this includes patients on a transplant list with the intention to transplant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00692770

  Show 234 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00692770     History of Changes
Other Study ID Numbers: 12414, 2008-001087-36
Study First Received: June 5, 2008
Last Updated: March 17, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Chile: Instituto de Salud Publica de Chile
Mexico: Federal Commission for Sanitary Risks Protection
Austria: Ethikkommission
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Bulgaria: Bulgarian Drug Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: German Institute of Medical Documentation and Information
Greece: Ethics Committee
Italy: The Italian Medicines Agency
Romania: National Medicines Agency
Russia: Ethics Committee
Switzerland: Swissmedic
Sweden: Ethikkommission
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
China: Food and Drug Administration
Japan: National Institute of Health Sciences
Hong Kong: Department of Health
Korea: Food and Drug Administration
New Zealand: Medsafe
Singapore: Health Sciences Authority
Taiwan: Department of Health
United States: Food and Drug Administration

Keywords provided by Bayer:
Hepatocellular carcinoma
Sorafenib
Adjuvant
Surgical resection
Ablation
Nexavar
Adjuvant therapy
Liver cancer
HCC
STORM

Additional relevant MeSH terms:
Sorafenib
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014