Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM) - Full Text View

Sponsor:	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

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.

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Sorafenib Sorafenib tosylate

U.S. FDA Resources

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:	November 2011
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 234 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided by Bayer

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Printz C. Clinical trials of note. Sorafenib as adjuvant treatment in the prevention of disease recurrence in patients with hepatocellular carcinoma (HCC) (STORM). Cancer. 2009 Oct 15;115(20):4646. No abstract available.

Responsible Party:	Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers:	12414, 2008-001087-36, STORM
Study First Received:	June 5, 2008
Last Updated:	October 20, 2009
ClinicalTrials.gov Identifier:	NCT00692770 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Hepatocellular,
Sorafenib,
Adjuvant,
Surgical resection,
Ablation

Additional relevant MeSH terms:

Liver Diseases
Neoplasms by Histologic Type
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Carcinoma, Hepatocellular
Physiological Effects of Drugs
Adjuvants, Immunologic
Enzyme Inhibitors
Protein Kinase Inhibitors

Pharmacologic Actions
Carcinoma
Liver Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Adenocarcinoma
Sorafenib
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 05, 2009