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Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM)
This study is currently recruiting participants.
Verified by Bayer, January 2009
Sponsored by: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00692770
  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 III

Drug Information available for: Sorafenib Sorafenib tosylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Recurrence Free Survival [ Time Frame: approximately 40 months from first patient first visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to recurrence [ Time Frame: approximately 40 months from first patient first visit ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: approximately 80 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 40 months from first patient first visit ] [ Designated as safety issue: No ]
  • Evaluation of biomarkers. [ Time Frame: approximately 40 months from first patient first visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 1100
Study Start Date: August 2008
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1: Experimental 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.
Arm 2: Placebo Comparator 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.
  • 4 weeks (28 days ± 7 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.
  • Uncontrolled ascites (defined as not easily controlled with diuretic treatment)
  • Encephalopathy
  • History of GI bleeding within 30 days.
  • 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 (including sorafenib or any other molecular therapy) is excluded.
  • Major surgery within 4 weeks of start of study, except for surgical resection or local ablation of HCC.
  • Investigational drug therapy outside of this trial during or within 4 weeks of study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00692770

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

  Show 175 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

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Responsible Party: Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers: 12414, 2008-001087-36, STORM
Study First Received: June 5, 2008
Last Updated: January 13, 2009
ClinicalTrials.gov Identifier: NCT00692770  
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Hepatocellular,
Sorafenib,
Adjuvant,
Surgical resection,
Ablation

Study placed in the following topic categories:
Liver Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms
Recurrence
Carcinoma
Liver Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Sorafenib
Neoplasms, Glandular and Epithelial
Hepatocellular carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009