Carcinoma Renal CellsPhase 2SOGUG/0107NCT00663559
Sunitinib in Patients With Renal Cells Carcinoma Metastasic or Locally Avanced in Patients Not Candidates to Curative Previous Nefrectomy
A Phase 2 study testing Sunitinib in people with Carcinoma Renal Cells, run by Spanish Oncology Genito-Urinary Group at 7 sites in Spain.
Trial summary
The purpose of this trial is to determinate the efficacy of Sunitinib in patients with renal cells carcinoma metastasic or locally avanced in patints not candidates to inicial curative nefrectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma Renal Cells
- What is being tested?
- Sunitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 7 sitesSpain
- Study dates
- Feb 2008to Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must give their written informed consent before any procedure related to the study is performed.
- Patients with renal clear cell carcinoma metastatic or locally advanced, histologically or cytologically documented.The patients with metastasic disease must be not condidated to curative nefrectomy as investigator criteria.
- Assessable or measurable disease according to RECIST criteria. The lesions previosly radiated is not considered as target.
- Ages equal or superior to 18 years old.
- ECOG ≤ 1
- Patients with a life expectancy superior to 12 weeks.
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- Patients with adequate organic function, according to the following criteria:
- . Medular reserve: Neutrophils absolute count≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L Haemoglobin ≥ 9g/dl
- . Hepatic function: Total bilirubin < 1.5 times the superior limit of normality ALT and AST < 2.5 times the superior limit of normality (< 5 times the superior limit of normality in case of liver failure due to cancer)
- . Seric Albumin ≥ 1.5 times the superior limit of normality
- . Renal Function: Cleary creatinine > 30ml/min
- . FEVI > LIN according to ECO or MUGA
- Patients who are capable of accomplishing the study's requirements and without any impediments to follow the instructions while on study
Who cannot join
- Pregnant or breastfeeding women. Women of fertile age must have a negative result in the pregnancy test performed 7 days before the beginning of the administration of the study medication. Both men and women included in the study must use an adequate contraceptive method.
- Patients that have received sistemic treatment previous to metastasic disease.
- Previous nefrectomy.
- Mayor Surgery, radiotherapy or sistemic therapy received in the last 3 weeks previous to the inclusion of the patient in the study, except paliative radiotherapy upper no target lesions.
- Radiotherapy upper > 25% bone marrow.
- Patients that are participating in any clinical trial.
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- Patients with a primary cancer diagnosis in thast 3 years, except superficial basaliomas, superficial escamous carcinoma or in situ cervix carcinoma with aducuate treatment.
- Following events in the last 12 months previous to begin the treatment: myocardial infarction, unstable o severe angina, coronary/periferic place of arterial by-pass, congestive cardiac insufficiency, brain-vascular accident included transitory ischemia or lung embolism.
- Arterial uncontrolled hypertension nor controlated with drugs ( >150/100 mmHg despite adequate medical treatment).
- Cardiac arrhythmia with grade NCI CTCAE ≥2, auricular fibrillation all grade and/or QTc interval> 450mseg in men and > 470 mseg in women.
- Actually treatment with therapeutic dose with acenocumarol (except low dose for deep venous thrombosis).
- Patients that present previously known positive serology for HIV.
- Abuse of substances, clinical conditions, psychological or social, that may interfere with the patient's participation in the study or with the evaluation of the study's results.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Hospital CLINIC
Barcelona, Barcelona, 08036
Hospital Reina Sofía
Córdoba, Córdoba, 14004
Hospital de Jaén
Jaén, Jaén, 23007
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Hospital Central de Asturias
Oviedo, Principality of Asturias, 33006
Hospital Parc Taulí
Sabadell, Barcelona, 08208
Hospital lozano Blesa
Zaragoza, Zaragoza, 50009
About this study
Official title: Study Phase II to Determinate the Efficacy of Sunitinib in Patients With Renal Cells Carcinoma Metastasic or Locally Avanced in Patients Not Candidates to Curative Previous Nefrectomy
The purpose of this trial is to determinate the efficacy of Sunitinib in patients with renal cells carcinoma metastasic or locally avanced in patints not candidates to inicial curative nefrectomy.
Read the detailed description
Study phase II in with one arm in patients with renal cells carcinoma.
- Conditions
- Carcinoma Renal Cells
- Being tested
- Sunitinib
- Keywords
- renal, Sunitinib, Unresectable and/or metastatic renal cell cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunitinibDrug
Also called Sutent
Sunitinib 50mg oral in the morning during 4 weeks with 2 weeks of break.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | This study has only one arm with Sunitinib Receives: Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: every 12 weeks
Secondary outcomes (4)
Global survival
Measured: At last contact date or death date
Response global
Measured: Every 12 weeks
Duration of response
Measured: Every 12 weeks
Security and tolerability of Sunitinib
Measured: Every 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma Renal CellsStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Oncology Genito-Urinary Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José Luís González Larriba, MD, Study chair, SOGUG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663559
- Sponsor's protocol ID
- SOGUG/0107
- Acronym
- SOGUG/0107
- Status last verified
- Nov 2007
- First submitted
- 21 Apr 2008
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Phase II to Determinate the Efficacy of Sunitinib in Patients With Renal Cells Carcinoma Metastasic or Locally Avanced in Patients Not Candidates to Curative Previous Nefrectomy
- ClinicalTrials.gov ID
- NCT00663559
- Acronym / sponsor ID
- SOGUG/0107 / SOGUG/0107
- Conditions
- Carcinoma Renal Cells
- Keywords
- renal, Sunitinib, Unresectable and/or metastatic renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Spanish Oncology Genito-Urinary GroupUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 22 Apr 2008 (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 of this trial is to determinate the efficacy of Sunitinib in patients with renal cells carcinoma metastasic or locally avanced in patints not candidates to inicial curative nefrectomy.
Detailed description
Study phase II in with one arm in patients with renal cells carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: SunitinibThis study has only one arm with Sunitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients must give their written informed consent before any procedure related to the study is performed.
- Patients with renal clear cell carcinoma metastatic or locally advanced, histologically or cytologically documented.The patients with metastasic disease must be not condidated to curative nefrectomy as investigator criteria.
- Assessable or measurable disease according to RECIST criteria. The lesions previosly radiated is not considered as target.
- Ages equal or superior to 18 years old.
- ECOG ≤ 1
Key exclusion criteria (13 listed)
- Pregnant or breastfeeding women. Women of fertile age must have a negative result in the pregnancy test performed 7 days before the beginning of the administration of the study medication. Both men and women included in the study must use an adequate contraceptive method.
- Patients that have received sistemic treatment previous to metastasic disease.
- Previous nefrectomy.
- Mayor Surgery, radiotherapy or sistemic therapy received in the last 3 weeks previous to the inclusion of the patient in the study, except paliative radiotherapy upper no target lesions.
- Radiotherapy upper > 25% bone marrow.
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 |
|---|---|---|
| SunitinibAlso: SutentSunitinib 50mg oral in the morning during 4 weeks with 2 weeks of break. | Drug | 1 |
Primary outcome
Progression-free survival
Time frame: every 12 weeks
4 secondary outcomes
Global survival
Time frame: At last contact date or death date
Response global
Time frame: Every 12 weeks
Duration of response
Time frame: Every 12 weeks
Security and tolerability of Sunitinib
Time frame: Every 4 weeks
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 18 Dec 2014.
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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.
José Luís González Larriba, MD study chair
SOGUG
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sunitinib in people with Carcinoma Renal Cells, run by Spanish Oncology Genito-Urinary Group at 7 sites in Spain.
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 13 inclusion and 13 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 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. 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?
Progression-free survival (time frame: every 12 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 18 Dec 2014.