Metastatic Renal Cell CarcinomaPhase 2MERITSNCT00848640
Study of Sorafenib in Patients With Advanced Renal Cell Carcinoma
A Phase 2 study testing Sorafenib in people with Metastatic Renal Cell Carcinoma, run by Egyptian Foundation For Cancer Research at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- Sorafenib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2008to Mar 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patient must provide written informed consent prior to receiving Sorafenib.
- The male or female patient must be at least 18 years of age.
- The patient must have pathologically proven advanced Renal Cell Carcinoma.
- Only patients with measurable disease (According to RECIST) at baseline should be included in protocol where Disease Control Rate (DCR) is the primary endpoint.
- The patient requires Sorafenib as First line therapy as the patient is unsuitable for another approved first line therapy for advanced RCC.
- The patient must be, in the Investigator's opinion, reasonably likely to benefit from treatment with Sorafenib as a single agent.
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- The patient must have an Eastern Cooperative Oncology Group performance status of 0 - 2.
- The patient will not require other systemic anti-cancer chemotherapy, immunotherapy or hormonal therapy, except for bisphosphonates while taking Sorafenib.
- 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.
- For patients, who have had major surgery, the wound must be completely healed prior to receiving Sorafenib treatment (4 weeks).
- The patient must have within normal Renal \& Hepatic function.
- The patient must have within normal CBC.
Who cannot join
- Patients who are currently enrolled in or have previously participated in any other Sorafenib trial.
- Suitable or received any other systemic therapy for treatment RCC (IL-2, INF)
- Patients who have a life expectancy of less than 2 months.
- Patients with metastatic brain or meningeal tumours.
- 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.
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- Concomitant Rifampicin.
- Non-measurable disease according to RECIST.
- Concomitant St. John's Wort (Hypericum perforatum).
- Warfarin (or similar medication) is allowed.
- 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).
- Patients with congestive heart failure greater than NYHA functional class II (symptomatic during ordinary activity)
- 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).
- Patients with active coronary artery disease or ischemia.
- Patients with Child-Pugh class C hepatic impairment.
- Patients with severe renal impairment (calculated creatinine clearance of < 30 ml/min) or who require dialysis.
- Patients with active uncontrolled hypertension.
- Patients with recent or active bleeding diathesis.
- Patients with any medical condition which could jeopardize their safety while taking an investigational drug.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- Sorafenib
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
400 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib | Experimental | Not described Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Disease Control Rate (DCR) defined as either CR, PR or SD for at least 8 weeks
Secondary outcomes (1)
Quality of life of patient with RCC and Progression Free Survival
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startOct 2008
- Primary completionDec 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egyptian Foundation For Cancer Research
- Sponsor type
- University, hospital or other
- Investigators
- Hussein M. Khaled, MD, Principal investigator, Egyptian Foundation For Cancer Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848640
- Sponsor's protocol ID
- 12594
- Acronym
- MERITS
- Status last verified
- Sep 2009
- First submitted
- 19 Feb 2009
- Last updated
- 26 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00848640
- Acronym / sponsor ID
- MERITS / 12594
- Conditions
- Metastatic Renal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Egyptian Foundation For Cancer ResearchUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 20 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorafenib | Experimental | Drug: Sorafenib |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- The patient must provide written informed consent prior to receiving Sorafenib.
- The male or female patient must be at least 18 years of age.
- The patient must have pathologically proven advanced Renal Cell Carcinoma.
- Only patients with measurable disease (According to RECIST) at baseline should be included in protocol where Disease Control Rate (DCR) is the primary endpoint.
- The patient requires Sorafenib as First line therapy as the patient is unsuitable for another approved first line therapy for advanced RCC.
Key exclusion criteria (19 listed)
- Patients who are currently enrolled in or have previously participated in any other Sorafenib trial.
- Suitable or received any other systemic therapy for treatment RCC (IL-2, INF)
- Patients who have a life expectancy of less than 2 months.
- Patients with metastatic brain or meningeal tumours.
- Patients are excluded who require any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sorafenib400 mg twice daily | Drug | Sorafenib |
Primary outcome
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
1 secondary outcome
Quality of life of patient with RCC and Progression Free Survival
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hussein M. Khaled, MD principal investigator
Egyptian Foundation For Cancer Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sorafenib in people with Metastatic Renal Cell Carcinoma, run by Egyptian Foundation For Cancer Research at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2010.