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

May 25, 2010 updated by: Egyptian Foundation For Cancer Research

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11553
        • Egyptian Foundation For Cancer Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sorafenib
Drug: Sorafenib
400 mg twice daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Disease Control Rate (DCR) defined as either CR, PR or SD for at least 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Quality of life of patient with RCC and Progression Free Survival
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Egyptian Foundation For Cancer Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hussein M. Khaled, MD, Egyptian Foundation For Cancer Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12594

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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