Kidney CancerPhase 2POORTORNCT01888042
Assessing Everolimus in Fist Line Treatment on Patients With Metastatic Kidney Cancer
A Phase 2 study testing Everolimus in people with Kidney Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
It is a an open label, multicentric, phase II study assessing the efficacy of everolimus (given per os) as a first line treatment in kidney cancer of bad prognosis. 92 patients will be included (anticipated). The treatment by everolimus will continue until progression, significant toxicity or withdraw of consent Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Everolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2011to Jul 2014
- 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
- Metastatic kidney cancer, regardless of histology (except Bellini carcinomas), with measurable or evaluable disease
- Age >= 18 years
- With Karnofsky ≥ 60
- Without prior treatment for metastatic cancer (chemotherapy, targeted therapy, or mTOR inhibitor)
- Bad prognosis, defined as follows: at least three of the following six criteria of poor prognosis:
- Karnofsky <80
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- LDH> 1.5 ULN
- hemoglobin <LLN
- corrected calcium> 2.5 mmol / l (10 mg / dl)
- Time frame between initial diagnostic and treatment <1 year
- More than one metastatic site
- medullary function: neutrophils ≥ 1.5 x 109 / L, Platelets ≥ 100 x 109 / L, Hb> 8g/dL
- Hepatic function: bilirubin: ≤ 1.5 x ULN, ALT and AST ≤ 2.5x ULN in the absence of hepatic metastasis ≤ 5x ULN if hepatic metastasis documented
- Renal function: creatinine <1.5 x ULN
- Life expectancy> 3 months,
- Patient signed informed consent and agreeing to comply with the requirements of the trial
Who cannot join
- Previous treatment with chemotherapy, targeted therapy, or mTOR inhibitor
- Previous radiotherapy in the last 2 weeks
- Chronic treatment with corticoids or immunosuppressive agents except substitutive opotherapy.. A washout period of at least 8 days must be respected before the patient inclusion.
- Patients with brain metastases untreated or uncontrolled by prior treatment. The non-progression of the metastases must be proved by comparing two brain scans separated by a minimum interval of 6 weeks.
- Active bleeding
- Patient with positive serology HBs (Ag HBs (+) and AC anti-HBc (+)
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- Hypersensitivity to everolimus, sirolimus, to other rapamycin derivatives or to any of the excipients
- Severe or uncontrolled medical pathology:
- unstable angina, symptomatic heart failure, myocardial infarction ≤ 6 months before randomization, severe rhythm disorder,
- Uncontrolled diabetes with glycaemia> 1.5X ULN.
- Active or uncontrolled infection.
- cirrhosis or chronic active hepatitis,
- severe alteration in lung function (> 50% decrease in FEV or vital capacity)
- Other cancer within the past 3 years, with the exception of basal cell carcinoma and carcinoma in situ of the cervix
- Pregnant or lactating woman, and adults refusing an effective contraceptive method
- Participation in another clinical trial with an investigational drug
- Refusal of the patient to comply with the rules of the clinical trial
- Person deprived of liberty or person under guardianship, inability to submit to medical treatment test for geographical, social or psychological reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study Assessing Everolimus as Fist Line Treatment in Patients With Metastatic Kidney Cancer of Bad Prognosis
It is a an open label, multicentric, phase II study assessing the efficacy of everolimus (given per os) as a first line treatment in kidney cancer of bad prognosis.
92 patients will be included (anticipated). The treatment by everolimus will continue until progression, significant toxicity or withdraw of consent
- Conditions
- Kidney Cancer
- Being tested
- Everolimus
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
10 mg (1 tablet of 10 mg)
| Study group | Role | What they receive |
|---|---|---|
| Everolimus | Experimental | Everolimus will be administered per os every day at the same hour immediately after a meal with a glass of water 10 mg (1 tablet of 10 mg) Receives: Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: From inclusion to progression, significant toxicity or death wichever come first up to 56 months
Secondary outcomes (3)
Response rate
Response rate based on RECIST 1.1 criteria
Measured: From inclusion to progression, significant toxicity or death whichever come first up to 56 months
Toxicity of Everolimus
Measured: From inclusion to progression, significant toxicity or death whichever come first up to 56 months
Progression Free Survival (PFS)
Measured: From inclusion to progression, significant toxicity or death whichever come first up to 56 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startJul 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard ESCUDIER, Study chair, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888042
- Sponsor's protocol ID
- 2011-00979-14
- Other IDs
- 2011/1733
- Acronym
- POORTOR
- Status last verified
- Feb 2016
- First submitted
- 25 Jun 2013
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Assessing Everolimus as Fist Line Treatment in Patients With Metastatic Kidney Cancer of Bad Prognosis
- ClinicalTrials.gov ID
- NCT01888042
- Acronym / sponsor ID
- POORTOR / 2011-00979-14
- Conditions
- Kidney Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 27 Jun 2013 (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.
It is a an open label, multicentric, phase II study assessing the efficacy of everolimus (given per os) as a first line treatment in kidney cancer of bad prognosis.
92 patients will be included (anticipated). The treatment by everolimus will continue until progression, significant toxicity or withdraw of consent
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Everolimus | Experimental | Drug: EverolimusEverolimus will be administered per os every day at the same hour immediately after a meal with a glass of water 10 mg (1 tablet of 10 mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Metastatic kidney cancer, regardless of histology (except Bellini carcinomas), with measurable or evaluable disease
- Age >= 18 years
- With Karnofsky ≥ 60
- Without prior treatment for metastatic cancer (chemotherapy, targeted therapy, or mTOR inhibitor)
- Bad prognosis, defined as follows: at least three of the following six criteria of poor prognosis:
Key exclusion criteria (18 listed)
- Previous treatment with chemotherapy, targeted therapy, or mTOR inhibitor
- Previous radiotherapy in the last 2 weeks
- Chronic treatment with corticoids or immunosuppressive agents except substitutive opotherapy.. A washout period of at least 8 days must be respected before the patient inclusion.
- Patients with brain metastases untreated or uncontrolled by prior treatment. The non-progression of the metastases must be proved by comparing two brain scans separated by a minimum interval of 6 weeks.
- Active bleeding
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 |
|---|---|---|
| Everolimus10 mg (1 tablet of 10 mg) | Drug | Everolimus |
Primary outcome
Overall Survival (OS)
Time frame: From inclusion to progression, significant toxicity or death wichever come first up to 56 months
3 secondary outcomes
Response rate
Time frame: From inclusion to progression, significant toxicity or death whichever come first up to 56 months
Toxicity of Everolimus
Time frame: From inclusion to progression, significant toxicity or death whichever come first up to 56 months
Progression Free Survival (PFS)
Time frame: From inclusion to progression, significant toxicity or death whichever come first up to 56 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2016.
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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.
Bernard ESCUDIER study chair
Gustave Roussy, Cancer Campus, Grand Paris
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 Everolimus in people with Kidney Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
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 16 inclusion and 18 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: stopped early, as of the sponsor's last update on 10 Feb 2016. 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 France. 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 was stopped early. Results are not available in the source record.
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?
Overall Survival (OS) (time frame: From inclusion to progression, significant toxicity or death wichever come first up to 56 months). 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 10 Feb 2016.