Metastatic Renal Cell CarcinomaPhase 2SUNRISESNCT01784978
Efficacy Study of Sunitinib and Everolimus (Rotational vs Sequential Arm) in Pats. With m Clear Cell Renal Cancer
A Phase 2 study testing Sunitinib and Everolimus in people with Metastatic Renal Cell Carcinoma, run by Associació per a la Recerca Oncologica, Spain at 10 sites in 3 countries.
Trial summary
The objective of this study is to assess the progression-free survival, of patients who receive rotations of sunitinib and everolimus versus patients who receive sunitinib as a first line treatment followed by everolimus when progression occurs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- Sunitinib and Everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 12 Feb 2013to 8 May 2017
- 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
- Renal cell carcinoma with a predominant clear cell component confirmed by histology.
- Advanced disease: metastatic AND, not suitable for resection
- Male or female, aged 18 years or older
- ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 or 1
- Low or intermediate MSKCC (Memorial Sloan Kettering Cancer Center) prognostic risk score,i.e. no more than 2 of the following:
- Karnofsky performance status (<80%)
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- Low serum hemoglobin (≤ 13 g/dL for males and ≤ 11.5 g/dL for females)
- High corrected serum calcium (≥ 10 mg/dL)
- Target and/or non-target lesions according to RECIST 1.1 ( Response Evaluation Criteria in Solid Tumors)
- Expected survival of at least 3 months.
- No prior systemic treatment. But adjuvant treatment is ok if stopped from ≥ 24 months
- Adequate bone marrow function as shown by:
- Adequate liver function as shown by:
- Adequate renal function as shown by serum creatinine ≤ 1.5 x ULN (upper limit of normal)
- Left ventricular ejection fraction ≥55% on gated cardiac blood pool scan, or normal left ventricular function and fractional shortening on echocardiogram (according to institutional limits).
- SBP (systolic blood pressure) ≤140mmHg and DBP (diastolic blood pressure)
- 90mmHg (it is acceptable to initiate antihypertensive treatment prior to registration to achieve these goals).
- Able to commence treatment within 7 days of registration.
- Willing and able to comply with follow-up and all other protocol requirements.
- Written informed consent
Who cannot join
- Prior treatment with VEGF-targeting agents or multi-kinase inhibitors or mTOR-targeting agents
- Active central nervous system metastases.
- 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 last 4 w.
- Known to be HIV positive.
- Evidence of chronic hepatitis due to hepatitis B virus (HBV) or hepatitis C virus (HCV)
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- Clinically significant heart disease (NYHA Class III or IV)
- History of hypertension requiring hospitalization.
- Other serious illnesses,
- Immunotherapy or chemotherapy in the last 4 w (6 weeks for nitrosoureas)
- Major surgery in the last 4 w, or planned in the next 6 w
- Radiation therapy in the last 2 w, or planned in the next 6 w
- NCI CTCAE (Common Toxicity Criteria for Adverse Effects) version 4.0 grade 3 or worse hemorrhage in last 4 w.
- 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.
- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.
- Ongoing cardiac dysrhythmias of NCI CTCAE version 4.0 grade ≥2, atrial fibrillation of any grade, or prolongation of the corrected QT interval (QTc) to >450 msec for males or >470 msec for females
- Uncontrolled diabetes as defined by fasting serum glucose >1.5 X ULN.
- Pregnancy,lactation. Inadequate contraception.
- Known allergy or hypersensitivity to everolimus, sunitinib or iodine.
- Medical or psychiatric condition that compromises the patient's ability to give informed consent.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Spain8 sites
Hospital del Mar
Barcelona, 08003
Hospital Universitario 12 de Octubre
Madrid, 28026
Hospital Clínico San Carlos
Madrid, 28040
Clara Campal. Hospital Sanchinarro
Madrid, 28050
Hospital Universitario Virgen de la Victoria
Málaga
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33006
Hospital Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital General Universitario de Valencia
Valencia
About this study
Official title: Randomized ph. II Study to Explore Efficacy and Feasibility of Upfront Rotations Between SUNitinib and Everolimus vs Sequential Treatment of 1st lIne Sunitinib & 2nd Line EverolimuS Until Progression in Pats Met. Clear Cell Renal Cancer
The objective of this study is to assess the progression-free survival, of patients who receive rotations of sunitinib and everolimus versus patients who receive sunitinib as a first line treatment followed by everolimus when progression occurs.
Read the detailed description
This is an open-label, randomized phase II study to investigate the feasibility of alternating cycles of treatment with sunitinib and everolimus compared to sequential treatment of sunitinib followed by everolimus.
The study population consists of adult patients (over 18 years old) with clear cell mRCC (Metastatic Renal Cell Cancer) who have not received prior therapy for their metastatic disease.
The purpose of the study is to determine the progression free survival, feasibility and safety profile of the experimental arm compared to standard of care.
In the experimental arm alternating treatment will consist of repeating cycles of 24 weeks of treatment consisting of 12 weeks of sunitinib 4weeks on 2 weeks off, 50 mg pd followed by 12 weeks of everolimus 10 mg per day 11 weeks on 1 week off in patients with metastatic clear cell renal cancer. The comparative arm will be the standard regimen of sunitinib (50 mg pd 4/2) until progression, followed thereafter by everolimus (10 mg per day continuously, 11/1) until progression.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- Sunitinib, Everolimus
- Keywords
- cancer, renal, metastatic, clear, cell, Sunitinib, Everolimus, Alternating
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasms, Neoplasm Metastasis, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunitinibDrug
Also called SUTENT
50 mg pd
EverolimusDrug
Also called AFINITOR
10 mg pd
| Study group | Role | What they receive |
|---|---|---|
| Rotational arm | Experimental | Alternating cycles of treatment with sunitinib and everolimus; repeating cycles of 24 weeks of treatment consisting of 12 weeks of sunitinib 4weeks on 2 weeks off, 50 mg pd followed by 12 weeks of everolimus 10 mg per day 11 weeks on 1 week off in patients with metastatic clear cell renal cancer. Receives: Drug: Sunitinib; Drug: Everolimus |
| Sequential arm | Active comparator | The comparative arm will be the standard regimen of sunitinib (50 mg pd 4/2) until progression, followed thereafter by everolimus (10 mg per day continuously, 11/1) until progression. Receives: Drug: Sunitinib; Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) rate 1 year
Measured: 12 months
Secondary outcomes (4)
PFS of rotational arm versus PFS of the 2 lines in control arm
Measured: From date of randomization until the date of first documented progression assesed up to 30 months
Overall Survival
Measured: From the date of the tratment start to the date of death or the last contact for alived patients at the momment of data censored. Assesed up to 30 months
Safety Profile
Measured: From the first treatment dose until 28 days after study treatment discontinuation. Assesed up to 30 months
Objective tumor response rate per arm
Measured: From the date of first tumor response to the date of progression or start date of other cancer therapy. Assesed up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2013 (estimated)
- Study start12 Feb 2013
- Primary completion8 May 2017
- Study completion8 May 2017
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associació per a la Recerca Oncologica, Spain
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, Pivotal S.L.
- Responsible party
- Sponsor
- Investigators
- Joaquim Bellmunt, MD/PhD, Principal investigator, Associacio Per la Recerca Oncológica (APRO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784978
- Sponsor's protocol ID
- SUNRISES STUDY (CRAD001LIC34T)
- Acronym
- SUNRISES
- Status last verified
- Sep 2017
- First submitted
- 11 Dec 2012
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rodriguez-Vida A, Bamias A, Esteban E, Saez MI, Lopez-Brea M, Castellano D, Caballero C, Gonzalez-Larriba JL, Calvo E, Macia S, Ravaud A, Bellmunt J. Randomised Phase II study comparing alternating cycles of sunitinib and everolimus vs standard sequential administration in first-line metastatic renal carcinoma (SUNRISES study). BJU Int. 2020 Nov;126(5):559-567. doi: 10.1111/bju.15165. Epub 2020 Aug 2.
PubMed 32654362
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized ph. II Study to Explore Efficacy and Feasibility of Upfront Rotations Between SUNitinib and Everolimus vs Sequential Treatment of 1st lIne Sunitinib & 2nd Line EverolimuS Until Progression in Pats Met. Clear Cell Renal Cancer
- ClinicalTrials.gov ID
- NCT01784978
- Acronym / sponsor ID
- SUNRISES / SUNRISES STUDY (CRAD001LIC34T)
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- cancer, renal, metastatic, clear, cell, Sunitinib, Everolimus, Alternating
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Associació per a la Recerca Oncologica, SpainUniversity, hospital or other
- Collaborators
- Novartis, Pivotal S.L.
- Study start
- 12 Feb 2013 (actual)
- Primary completion
- 8 May 2017 (actual)
- Study completion
- 8 May 2017 (actual)
- First posted
- 6 Feb 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.
The objective of this study is to assess the progression-free survival, of patients who receive rotations of sunitinib and everolimus versus patients who receive sunitinib as a first line treatment followed by everolimus when progression occurs.
Detailed description
This is an open-label, randomized phase II study to investigate the feasibility of alternating cycles of treatment with sunitinib and everolimus compared to sequential treatment of sunitinib followed by everolimus.
The study population consists of adult patients (over 18 years old) with clear cell mRCC (Metastatic Renal Cell Cancer) who have not received prior therapy for their metastatic disease.
The purpose of the study is to determine the progression free survival, feasibility and safety profile of the experimental arm compared to standard of care.
In the experimental arm alternating treatment will consist of repeating cycles of 24 weeks of treatment consisting of 12 weeks of sunitinib 4weeks on 2 weeks off, 50 mg pd followed by 12 weeks of everolimus 10 mg per day 11 weeks on 1 week off in patients with metastatic clear cell renal cancer. The comparative arm will be the standard regimen of sunitinib (50 mg pd 4/2) until progression, followed thereafter by everolimus (10 mg per day continuously, 11/1) until progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotational arm | Experimental | Drug: Sunitinib, Drug: EverolimusAlternating cycles of treatment with sunitinib and everolimus; repeating cycles of 24 weeks of treatment consisting of 12 weeks of sunitinib 4weeks on 2 weeks off, 50 mg pd followed by 12 weeks of everolimus 10 mg per day 11 weeks on 1 week off in patients with metastatic clear cell renal cancer. |
| Sequential arm | Active comparator | Drug: Sunitinib, Drug: EverolimusThe comparative arm will be the standard regimen of sunitinib (50 mg pd 4/2) until progression, followed thereafter by everolimus (10 mg per day continuously, 11/1) until progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Renal cell carcinoma with a predominant clear cell component confirmed by histology.
- Advanced disease: metastatic AND, not suitable for resection
- Male or female, aged 18 years or older
- ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 or 1
- Low or intermediate MSKCC (Memorial Sloan Kettering Cancer Center) prognostic risk score,i.e. no more than 2 of the following:
Key exclusion criteria (20 listed)
- Prior treatment with VEGF-targeting agents or multi-kinase inhibitors or mTOR-targeting agents
- Active central nervous system metastases.
- 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 last 4 w.
- Known to be HIV positive.
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: SUTENT50 mg pd | Drug | Rotational arm, Sequential arm |
| EverolimusAlso: AFINITOR10 mg pd | Drug | Rotational arm, Sequential arm |
Primary outcome
Progression-free survival (PFS) rate 1 year
Time frame: 12 months
4 secondary outcomes
PFS of rotational arm versus PFS of the 2 lines in control arm
Time frame: From date of randomization until the date of first documented progression assesed up to 30 months
Overall Survival
Time frame: From the date of the tratment start to the date of death or the last contact for alived patients at the momment of data censored. Assesed up to 30 months
Safety Profile
Time frame: From the first treatment dose until 28 days after study treatment discontinuation. Assesed up to 30 months
Objective tumor response rate per arm
Time frame: From the date of first tumor response to the date of progression or start date of other cancer therapy. Assesed up to 30 months
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Derived from this study: PubMed 32654362Rodriguez-Vida A, Bamias A, Esteban E, Saez MI, Lopez-Brea M, Castellano D, Caballero C, Gonzalez-Larriba JL, Calvo E, Macia S, Ravaud A, Bellmunt J. Randomised Phase II study comparing alternating cycles of sunitinib and everolimus vs standard sequential administration in first-line metastatic renal carcinoma (SUNRISES study). BJU Int. 2020 Nov;126(5):559-567. doi: 10.1111/bju.15165. Epub 2020 Aug 2.
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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.
Joaquim Bellmunt, MD/PhD principal investigator
Associacio Per la Recerca Oncológica (APRO)
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sunitinib and Everolimus in people with Metastatic Renal Cell Carcinoma, run by Associació per a la Recerca Oncologica, Spain at 10 sites in 3 countries.
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 20 inclusion and 20 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 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain, France, Greece. 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 (reason given: Lack of recruitment). 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?
Progression-free survival (PFS) rate 1 year (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01784978, which also lists 1 linked publication.
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 2 Oct 2017.