Renal Cell CarcinomaPhase 4ORCHIDEENCT02338570
Outcome-related Factors in Patients With Metastatic Renal Cell Carcinoma Treated With Everolimus (ORCHIDEE)
A Phase 4 study testing Everolimus in people with Renal Cell Carcinoma, run by Mario Negri Institute for Pharmacological Research at 8 sites in Italy.
Trial summary
Evaluation of unfavourable outcome-related factors in patients affected by renal cell cancer in treatment with everolimus and previously treated with a Vascular endothelial growth factor (VEGF) inhibitor (i.e. sunitinib, sorafenib,pazopanib, or bevacizumab+interferon) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- 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
- 31 participants
- Where
- 8 sitesItaly
- Study dates
- Jul 2015to Feb 2018
- Phase
- Phase 4
- 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
- Male or female, aged 18 years or older, with histologically or cytologically confirmed mRCC (clear cell or not clear cell);
- ECOG-PS 0-1-2;
- With target and/or non-target lesions according to Response Evaluation Criteria In Solid Tumours (RECIST) 1.1;
- Following failure of a previous treatment with VEGF-targeted therapy (e.g. sunitinib, sorafenib, pazopanib, or bevacizumab+interferon);
- For whom a decision has been taken to initiate everolimus treatment or patient currently receiving treatment with everolimus by a period of time ≤30 days;
- Willing and able to comply with follow-up and all other protocol requirements and able to commence treatment within 21 days;
- Written informed consent obtained before any screening procedure and according to local guidelines.
Who cannot join
- Patients who meet any of the following criteria will be excluded from study entry:
- Previous treatment with everolimus or at the date of written informed consent provision receiving everolimus by more than 30 days;
- Symptomatic central nervous system metastases. Patients may be eligible if the central nervous system metastases have been adequately treated (surgery or radiotherapy), and do not require ongoing corticosteroids for control of symptoms and have had no evidence of progression for at least three months;
- Other malignancy diagnosed within the last 5 years, except the following, if adequately treated: superficial squamous cell carcinoma or basal cell carcinoma of skin, superficial bladder cancer (T1 and G1 or T1 and G2), stage 1 cervical cancer;
- Treatment with an investigational agent in the past 4 weeks;
- Clinically relevant human immunodeficiency virus, hepatitis B virus, hepatitis C virus infection;
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- Non adequate liver function as shown by:
- serum or plasma ALT and AST >3.0x upper limit of normal (ULN) >5 if hepatic metastases are present;
- Serum or plasma total bilirubin: >1.5xULN (excepted for patients with Gilbert's syndrome);
- Non adequate renal function as shown by serum creatinine >2.5xULN;
- Any of the following in the last year: myocardial infarction, severe/ unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack or pulmonary embolism;
- Ongoing grade ≥2 cardiac dysrhythmias, atrial fibrillation of any grade or prolongation of the corrected QT interval to >450 msec for males or >470 msec for females;
- Pregnancy (negative pregnancy test required for women of child-bearing potential), breast feeding;
- Inadequate contraception. Women must be post-menopausal, surgically sterile, or use a reliable form of contraception. Men must be surgically sterile or use a barrier method of contraception;
- Known allergy or hypersensitivity to everolimus or its excipients.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
Spedali Civili
Brescia
Ospedale A Perrino
Brindisi
Istituto Europeo di Oncologia
Milan
Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale
Naples
AOU Maggiore della Carità
Novara
Casa di Cura La Maddalena
Palermo
Unicampus Biomedico
Roma
AOU San Giovanni di Dio e Ruggi D'Aragona
Salerno
About this study
Official title: Outcome-related Factors in Patients With Metastatic Renal Cell Carcinoma Treated With Everolimus After Failure of a First-line Treatment With VEGF Inhibitor
Evaluation of unfavourable outcome-related factors in patients affected by renal cell cancer in treatment with everolimus and previously treated with a Vascular endothelial growth factor (VEGF) inhibitor (i.e. sunitinib, sorafenib,pazopanib, or bevacizumab+interferon)
Read the detailed description
Predictive factors to be considered are: histology, Heng risk group, Eastern Cooperative Oncology Group-performance status (ECOG-PS), site of metastases, glycemia and cholesterolemia.
The data collected in this "real life" population could contribute to identify clinical factors that predict favourable outcomes in patients treated with everolimus after failure or a a first-line treatment with a VEGF inhibitor.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Everolimus
- 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.
EverolimusDrug
Also called Afinitor
Patients will start study treatment on day 1 and will be treated with daily doses of everolimus (10 mg daily tablets).
| Study group | Role | What they receive |
|---|---|---|
| Everolimus | Other | All patients will receive everolimus 10 mg orally per day. Treatment will continue until progression, unacceptable toxicity, patient refusal or medical decision Receives: Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
predictive factors identification
To identify factors predictive of a favourable outcome, in terms of survival free from an unfavourable event, in patients treated with everolimus as second line treatment for metastatic renal cell carcinoma (mRCC). A favourable outcome is being alive and on treatment without both disease progression (according to RECIST 1.1) and HRQoL deterioration (7-point decrease from baseline evaluation on the EQ-5D VAS).
Measured: 36 months
Secondary outcomes (4)
Progression free survival (PFS) of everolimus as second line treatment
PFS distributions will be estimated using the Kaplan-Meier method and compared using the log-rank test.
Measured: 36 months
health related quality of life (HRQoL)
As measured by EQ-5D questionnaire. It will be described at each time by using summary statistical measures for continuous variables
Measured: 36 months
drug-related toxicity
assessed by the National Cancer Institute-Common Terminology Criteria for adverse events (NCI-CTCAE), version 4.03.
The frequency of maximum toxicity grade experienced by each patient for each specific toxicity will be presented as well as the frequency of patients experiencing grade 3 or 4 (grade 2 for neurotoxicity) events, and SADRs.
Measured: 36 months
compliance
Treatment compliance will be assessed by evaluating the dose intensity (total dose divided by duration of exposure to treatment in weeks), and calculating the frequencies and proportion of patients who modified or interrupted the treatment.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startJul 2015
- Primary completionFeb 2018
- Study completionFeb 2018
Why it stopped: Stopped on November 16th 2016, because of recruitment failure.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giacomo Cartenì, Principal investigator, Azienda Ospedaliera "Antonio Cardarelli", Napoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338570
- Sponsor's protocol ID
- IRFMN-RCC-6691
- Acronym
- ORCHIDEE
- Status last verified
- Nov 2016
- First submitted
- 7 Jan 2015
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome-related Factors in Patients With Metastatic Renal Cell Carcinoma Treated With Everolimus After Failure of a First-line Treatment With VEGF Inhibitor
- ClinicalTrials.gov ID
- NCT02338570
- Acronym / sponsor ID
- ORCHIDEE / IRFMN-RCC-6691
- Conditions
- Renal Cell Carcinoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped on November 16th 2016, because of recruitment failure.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 14 Jan 2015 (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.
Evaluation of unfavourable outcome-related factors in patients affected by renal cell cancer in treatment with everolimus and previously treated with a Vascular endothelial growth factor (VEGF) inhibitor (i.e. sunitinib, sorafenib,pazopanib, or bevacizumab+interferon)
Detailed description
Predictive factors to be considered are: histology, Heng risk group, Eastern Cooperative Oncology Group-performance status (ECOG-PS), site of metastases, glycemia and cholesterolemia.
The data collected in this "real life" population could contribute to identify clinical factors that predict favourable outcomes in patients treated with everolimus after failure or a a first-line treatment with a VEGF inhibitor.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Everolimus | Other | Drug: EverolimusAll patients will receive everolimus 10 mg orally per day. Treatment will continue until progression, unacceptable toxicity, patient refusal or medical decision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, aged 18 years or older, with histologically or cytologically confirmed mRCC (clear cell or not clear cell);
- ECOG-PS 0-1-2;
- With target and/or non-target lesions according to Response Evaluation Criteria In Solid Tumours (RECIST) 1.1;
- Following failure of a previous treatment with VEGF-targeted therapy (e.g. sunitinib, sorafenib, pazopanib, or bevacizumab+interferon);
- For whom a decision has been taken to initiate everolimus treatment or patient currently receiving treatment with everolimus by a period of time ≤30 days;
Key exclusion criteria (15 listed)
- Previous treatment with everolimus or at the date of written informed consent provision receiving everolimus by more than 30 days;
- Symptomatic central nervous system metastases. Patients may be eligible if the central nervous system metastases have been adequately treated (surgery or radiotherapy), and do not require ongoing corticosteroids for control of symptoms and have had no evidence of progression for at least three months;
- Other malignancy diagnosed within the last 5 years, except the following, if adequately treated: superficial squamous cell carcinoma or basal cell carcinoma of skin, superficial bladder cancer (T1 and G1 or T1 and G2), stage 1 cervical cancer;
- Treatment with an investigational agent in the past 4 weeks;
- Clinically relevant human immunodeficiency virus, hepatitis B virus, hepatitis C virus infection;
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 |
|---|---|---|
| EverolimusAlso: AfinitorPatients will start study treatment on day 1 and will be treated with daily doses of everolimus (10 mg daily tablets). | Drug | Everolimus |
Primary outcome
predictive factors identification
Time frame: 36 months
To identify factors predictive of a favourable outcome, in terms of survival free from an unfavourable event, in patients treated with everolimus as second line treatment for metastatic renal cell carcinoma (mRCC). A favourable outcome is being alive and on treatment without both disease progression (according to RECIST 1.1) and HRQoL deterioration (7-point decrease from baseline evaluation on the EQ-5D VAS).
4 secondary outcomes
Progression free survival (PFS) of everolimus as second line treatment
Time frame: 36 months
health related quality of life (HRQoL)
Time frame: 36 months
drug-related toxicity
Time frame: 36 months
compliance
Time frame: 36 months
Results and safety
The study was stopped early (reason given: Stopped on November 16th 2016, because of recruitment failure.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
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Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
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Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
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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.
Giacomo Cartenì principal investigator
Azienda Ospedaliera "Antonio Cardarelli", Napoli
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Everolimus in people with Renal Cell Carcinoma, run by Mario Negri Institute for Pharmacological Research at 8 sites in Italy.
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 7 inclusion and 15 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 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 (reason given: Stopped on November 16th 2016, because of recruitment failure.). 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?
predictive factors identification (time frame: 36 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 5 Feb 2018.