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Completed

NCT Number: NCT00105443

A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

The purpose of the study is: Find out if patients receiving sorafenib will live longer. Find out if sorafenib has any effect on patient reported outcomes. Find out if sorafenib prevents the growth of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics (PK) in patients with liver cancer.

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mar del Plata, Buenos Aires, Argentina

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About this study

The following abbreviations were used in the Adverse Event section:

  • international normalized ratio (inr)
  • Common Terminology Criteria for Adverse Events (ctcae)
  • Not Otherwise Specified (nos)
  • Gastrointestinal (gi)
  • Central nervous system (cns)
  • Absolute Neutrophil Count (anc)
  • Alanine aminotransferase (ALT)
  • Aspartate aminotransferase (AST)
  • Creatine phosphokinase (cpk)
  • Gammaglutamyltransferase (ggt)
  • Genitourinary (gu)
  • Atrioventricular (av)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages eligible for study: 18 years and above, Genders eligible for study: both
  • Patients who have a life expectancy of at least 12 weeks
  • Patients with histologically or cytologically documented Hepatocellular Carcinoma (HCC)
  • Patients must have at least one tumor lesion that meets both of the following criteria: (1) Accurately measured in at least one dimension according to RECIST (Response Evaluation Criteria in Solid Tumors) (2) Not previously treated with local therapy
  • Patients who have an ECOG (Eastern Cooperative Oncology Group) PS (Performance Status) of 0, 1, or 2

Exclusion criteria

  • Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta [Noninvasive papillary carcinoma], Tis [Carcinoma in situ: "flat tumor"] & T1 [Tumor invades subepithelial connective tissue]). Any cancer curatively treated > 3 years prior to entry is permitted
  • Renal failure requiring hemo- or peritoneal dialysis
  • History of cardiac disease
  • Active clinically serious infections
  • Known history of human immunodeficiency virus (HIV) infection
  • Known central nervous system tumors including metastatic brain disease
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry

Treatment and study plan

Sorafenib (Nexavar, BAY43-9006)

Drug

Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment.

Placebo

Drug

Sorafenib-matching placebo tablets were orally administered twice daily (bid).

Primary outcomes

  1. Overall Survival (OS)

    Time frame: from randomization to death due to any cause until an average 7.2 months later up to the data cut-off date approximately 19 months after start of enrollment

    Overall Survival was defined as the time from date of starting treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

  2. Time to Symptomatic Progression (TTSP)

    Time frame: from randomization to the first documented symptomatic progression until an average 4.8 months later up to the data cut-off date approximately 19 months after start of enrollment

    TTSP was defined as the time from randomization to the first documented symptomatic progression.

Secondary outcomes

  1. Time to Progression (TTP)

    Time frame: from randomization to disease progression based on radiological assessment until an average 2.8 months later up to the data cut-off date approximately 19 months after start of enrollment

    TTP was defined as the time from randomization to disease progression (radiological only). Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.

  2. Disease Control (DC)

    Time frame: time from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment

    The DC is defined as the number of subjects with a best response rating of complete response (CR), partial response (PR), or stable disease (SD) that is maintained at least 28 days from the first manifestation of that rating. Definitions: CR = disappearance of all clinical and radiological tumor lesions; PR = at least 30% decrease in sum of the longest diameters of tumor lesions; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease.

  3. Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire

    Time frame: from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment

    PRO is a disease-specific measure, developed as symptom-focused approach in HCC and measured by the response rates for the PWB and FWB subscales of the 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep response rate was based on the number of subjects who achieved the 8-point minimally important difference (MID) for this subscale. FACT-Hep total score ranges from 0 to 180, where the highest score represents a maximum achievable quality of life (QoL) value.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Phase III Randomized, Placebo-controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

Acronym: SHARP

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Mar 15, 2005
Registry last updated
Oct 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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