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

This study has been completed.
Sponsor:
Information provided by:
Egyptian Foundation For Cancer Research
ClinicalTrials.gov Identifier:
NCT00848640
First received: February 19, 2009
Last updated: May 25, 2010
Last verified: September 2009
  Purpose

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 Intervention Phase
Metastatic Renal Cell Carcinoma
Drug: Sorafenib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Egyptian Foundation For Cancer Research:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life of patient with RCC and Progression Free Survival [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Enrollment: 75
Study Start Date: October 2008
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sorafenib Drug: Sorafenib
400 mg twice daily

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848640

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

No publications provided

Responsible Party: Hussein Khaled, MD, Egyptian Foundation For Cancer Research
ClinicalTrials.gov Identifier: NCT00848640     History of Changes
Other Study ID Numbers: 12594
Study First Received: February 19, 2009
Last Updated: May 25, 2010
Health Authority: Egypt: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014