Study of Sorafenib in Patients With Advanced Renal Cell Carcinoma (MERITS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00848640
Recruitment Status : Completed
First Posted : February 20, 2009
Last Update Posted : May 26, 2010
Information provided by:
Egyptian Foundation For Cancer Research

Brief Summary:
The purpose study is to evaluate the efficacy and safety of Sorafenib as first line treatment for patients - unsuitable for another approved first line therapy - with advanced RCC in the Middle East Region.

Condition or disease Intervention/treatment Phase
Metastatic Renal Cell Carcinoma Drug: Sorafenib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center,Middle East, Phase-II Study, Non-comparative, of the RAF-Kinase Inhibitor Sorafenib in Patients With Advanced Renal Cell Carcinoma to Evaluate The Efficacy and Tolerability of the Drug
Study Start Date : October 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Sorafenib Drug: Sorafenib
400 mg twice daily

Primary Outcome Measures :
  1. evaluate the efficacy by evaluating the disease control rate (DCR) and safety of Sorafenib for first line patients unsuitable for another approved first line therapy with advanced RCC in the Middle East region. [ Time Frame: Disease Control Rate (DCR) defined as either CR, PR or SD for at least 8 weeks ]

Secondary Outcome Measures :
  1. Quality of life of patient with RCC and Progression Free Survival [ Time Frame: One year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. The patient must provide written informed consent prior to receiving Sorafenib.
  2. The male or female patient must be at least 18 years of age.
  3. The patient must have pathologically proven advanced Renal Cell Carcinoma.
  4. Only patients with measurable disease (According to RECIST) at baseline should be included in protocol where Disease Control Rate (DCR) is the primary endpoint.
  5. The patient requires Sorafenib as First line therapy as the patient is unsuitable for another approved first line therapy for advanced RCC.
  6. The patient must be, in the Investigator's opinion, reasonably likely to benefit from treatment with Sorafenib as a single agent.
  7. The patient must have an Eastern Cooperative Oncology Group performance status of 0 - 2.
  8. The patient will not require other systemic anti-cancer chemotherapy, immunotherapy or hormonal therapy, except for bisphosphonates while taking Sorafenib.
  9. Both male and female patients must use adequate barrier birth control methods during their participation in the protocol. The birth control methods must be used for 4 weeks for female patients and for 3 months for male patients after discontinuation of treatment with Sorafenib.
  10. For patients, who have had major surgery, the wound must be completely healed prior to receiving Sorafenib treatment (4 weeks).
  11. The patient must have within normal Renal & Hepatic function.
  12. The patient must have within normal CBC.

Exclusion Criteria:

  1. Patients who are currently enrolled in or have previously participated in any other Sorafenib trial.
  2. Suitable or received any other systemic therapy for treatment RCC (IL-2, INF)
  3. Patients who have a life expectancy of less than 2 months.
  4. Patients with metastatic brain or meningeal tumours.
  5. Patients are excluded who require any of the following:

    • Investigational drug therapy during the treatment with Sorafenib or within 30 days prior to their first dose of Sorafenib.
    • Concomitant Rifampicin.
  6. Non-measurable disease according to RECIST.
  7. Concomitant St. John's Wort (Hypericum perforatum).
  8. Warfarin (or similar medication) is allowed.
  9. Women who are pregnant or breast-feeding. Women of childbearing potential must have a negative pregnancy test performed within seven days of the start of study drug (please note that no laboratory data are collected in this study).
  10. Patients with congestive heart failure greater than NYHA functional class II (symptomatic during ordinary activity)
  11. Patients with cardiac arrhythmias greater than Grade 1 NCI CTCAE, Version 3.0 (conduction abnormality and supraventricular arrhythmia present but patient is asymptomatic; intervention not indicated, palpitations present and QTc > 0.45 - 0.47 second).
  12. Patients with active coronary artery disease or ischemia.
  13. Patients with Child-Pugh class C hepatic impairment.
  14. Patients with severe renal impairment (calculated creatinine clearance of < 30 ml/min) or who require dialysis.
  15. Patients with active uncontrolled hypertension.
  16. Patients with recent or active bleeding diathesis.
  17. Patients with any medical condition which could jeopardize their safety while taking an investigational drug.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00848640

Egyptian Foundation For Cancer Research
Cairo, Egypt, 11553
Sponsors and Collaborators
Egyptian Foundation For Cancer Research
Principal Investigator: Hussein M. Khaled, MD Egyptian Foundation For Cancer Research

Responsible Party: Hussein Khaled, MD, Egyptian Foundation For Cancer Research Identifier: NCT00848640     History of Changes
Other Study ID Numbers: 12594
First Posted: February 20, 2009    Key Record Dates
Last Update Posted: May 26, 2010
Last Verified: September 2009

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs