Metastatic Clear Cell Renal CancerPhase 1DEVELOPNCT01714765
Dose Escalation Study Investigating Everolimus and Dovitinib in Metastatic Clear Cell Renal Cancer
A Phase 1 study testing Dovitinib and Everolimus in people with Metastatic Clear Cell Renal Cancer, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
When kidney cancer spreads beyond the kidney, it is known as metastatic kidney cancer. This is very difficult to treat and almost all patients will die of their disease within 3 years. Sunitinib has become standard therapy for untreated patients with metastatic clear cell renal (kidney) cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Clear Cell Renal Cancer
- What is being tested?
- Dovitinib and Everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2011to Oct 2012
- Phase
- Phase 1
- 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
- Histopathologically confirmed clear cell renal carcinoma with measurable metastases on CT/MRI imaging (only a component of clear cell histology is required).
- Patients must have progression on or after stopping treatment with a VEGF receptor tyrosine kinase inhibitor (sunitinib and/or sorafenib)
- Prior vaccine therapy or treatment with cytokines (ie IL-2, Interferon) and/ or VEGF ligand inhibitors (bevacizumab) are permitted.
- Minimum of 18 years of age (there is no upper age limit)
- Radiological progressive disease.
- ECOG performance status of 0 and 1.
Show all 17Show fewer
- Prior exposure to targeted therapy within the previous 4 months. Targeted therapy consists of VEGF targeted agents or mTOR inhibitors. A gap of at least 2 week off therapy is required prior to study entry (this gap should be at least 6 weeks for bevacizumab).
- Evidence of measurable disease (ie, ≥1 malignant tumour mass that can be accurately measured in at least 1 dimension ≥ 20 mm with conventional computerized tomography [CT] scan or Magnetic Resonance Imaging [MRI], or ≥10 mm with spiral CT scan using a 5 mm or smaller contiguous reconstruction algorithm). Bone lesions, ascites, peritoneal carcinomatosis or miliary lesions, pleural or pericardial effusions, lymphangitis of the skin or lung, cystic lesions, or irradiated lesions are not considered measurable.
- Adequate organ function as defined by the following criteria:
- Total serum bilirubin ≤1.5 x ULN (patients with Gilbert's disease exempt),
- Serum transaminases <=3 x ULN (regardless of the presence or absence of liver metastases).
- Serum creatinine <=2 x ULN,
- Absolute neutrophil count (ANC) >= 1.5 x 109/L
- Platelets >= 100 x 109/L
- Life expectance >12 weeks
- Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrolment.
- Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures
Who cannot join
- Congestive heart failure, myocardial infarction or coronary artery bypass graft in the previous six months, ongoing severe heart disease.
- Females of child-bearing potential, defined as all women physiologically capable of becoming pregnant, without exceptions, Unless; They meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 IU/l, OR; Have past 6 weeks from surgical bilateral oophorectomy with or without hysterectomy OR;
- Females are expected to use two forms of contraception. The following combinations of contraception are acceptable:
- Surgical sterilization (e.g. bilateral tubal ligation)
- Diaphragm plus condom
- Intra-uterine device plus condom
Show all 28Show fewer
- Intra-uterine device plus diaphragm Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Note: Reliable contraception must be maintained throughout the study.
- Females of child bearing potential must have a negative pregnancy test prior to starting the study. Females must not be pregnant or lactating.
- Male subjects and their partners who are not using two highly effective methods of contraception, comprising a barrier method (e.g. condom with spermicidal gel) plus use by the female partner of a second method of contraception (e.g. hormonal, IUD, barrier method such as occlusive cap with spermicide). These measures should be in place for the entire duration of the study up the Study Completion visit, and males should refrain from fathering a child in the 12 months following the last dose of study medication.
- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
- Patients with a recent history(in the previous 3 months) of poorly controlled hypertension with resting blood pressure >150/100 mmHg in the presence or absence of a stable regimen of anti-hypertensive therapy, or patients who are requiring maximal doses of calcium channel blockers to stabilize blood pressure
- Mean QTc with Bazetts correction >480msec in screening ECG or history of familial long QT syndrome
- Any evidence of interstitial lung disease (bilateral, diffuse, parenchymal lung disease), especially pulmonary fibrosis.
- Significant haemorrhage (>30mL bleeding/episode in previous 3 months) or haemoptysis (>5mL fresh blood in previous 4 weeks)
- Recent (<14 days) major thoracic or abdominal surgery prior to entry into the study, or a surgical incision that is not fully healed
- Unresolved toxicity ≥ CTC grade 2 (except alopecia) from previous anti-cancer therapy.
- History of other malignancies (except for adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ or localised controlled prostate cancer or cervical cancer) within 2 years.
- Known inherited or acquired immunodeficiency
- Other concomitant anti-cancer therapy (excluding LHRH agonists).
- Current steroid use. Concomitant use of steroids on study should be considered an adverse event and the clinical trials unit should be contacted.
- Previous bone marrow transplant
- Uncontrolled diabetes (fasting glucose 2x ULN.)
- Patients with any severe and /or uncontrolled medical conditions such as serious uncontrolled cardiac arrhythmia, uncontrolled hyperlipidemia, active or uncontrolled serve infection, cirrhosis or persistent active hepatitis (where hepatitis is suspected, investigations must be undertaken) or severely impaired lung function.
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dovitinib or everolimus (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection).
- Patients who are currently receiving anticoagulation treatment with therapeutic doses of warfarin.
- Patient on strong or moderate inhibitors of cytochrome P450 3A4 include ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine, fosamprenavir, voriconazole, aprepitant, erythromycin, fluconazole, grapefruit juice, verapamil, or diltiazem
- Presence of brain metastases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study Investigating Everolimus and Dovitinib in Metastatic Clear Cell Renal Cancer
When kidney cancer spreads beyond the kidney, it is known as metastatic kidney cancer. This is very difficult to treat and almost all patients will die of their disease within 3 years.
Sunitinib has become standard therapy for untreated patients with metastatic clear cell renal (kidney) cancer. It targets a growth factor known as VEGF which is important in treating renal cancer. Although the results with this drug are impressive, patients develop resistance to the drug, relapse and die of renal cancer. It is currently standard practice is to treat patients with everolimus when resistance to sunitinib occurs; this is associated with clear clinical benefit. However the median time to progression with everolimus is 4.9 months in previously treated patients, therefore further improvement in treating patients is required. The optimal way of achieving this is to increase the efficacy of everolimus by adding agents which directly target the cause of resistance to sunitinib.
Read more
Dovitinib is a promising new drug in renal cancer. Dovitinib blocks cellular functions such as activation of downstream signalling molecules, cell proliferation and survival. Combining dovitinib and everolimus is very attractive.
This trial is aimed to establish the maximum tolerated dose for the combination of dovitinib and everolimus in clear call renal cancer, which can then be taken into a randomised phase II study.
A maximum of 30 patients will be recruited into this multi centre national trial.
Expansion Cohort:
The study has established the MAD and the MTD. The MTD was Cohort 0 (Everolimus 5mg and Dovitinib 200mg). 6 patients were recruited in this cohort with only 1 patient experiencing a DLT. A further 3 patients were recruited into Cohort 1 (Everolimus 5mg and Dovitinib 300mg), where 2 patients experienced a DLT.
A total of 7 assessable patients will be recruited during the expansion phase at the MTD (Cohort 0: Everolimus 5mg and Dovitinib 200mg) to further define the safety, tolerability, efficacy, PK and biological end points.
Assessable patients for the expansion cohort are defined as being on the study for a minimum of 6 weeks. Any patients enrolled who are not assessable will be replaced.
Read the detailed description
Renal cell cancer, also referred to as kidney cancer, is diagnosed in approximately 170,000 people worldwide annually, resulting in 82,000 deaths. Treatment for metastatic kidney cancer is difficult. Almost all of the patients die from their disease.
In 2006 a new drug called sunitinib, a tyrosine kinase inhibitor, transformed treatment options. It targets the development of new blood vessels within the cancer. Although the results with this drug are impressive, patients develop resistance a median after 11 months to the drug, relapse and die of renal cancer. It is currently standard practice to switch to everolimus when resistance to sunitinib occurs; this is associated with clear clinical benefit. However the median time to progression with everolimus is 4 months in previously treated patients, therefore further improvement in treating patients is required. The optimal way of achieving this is to increase the efficacy of everolimus by adding agents which directly target the cause of resistance to sunitinib.
dovitnib is a promising new drug the pharmacology data from a variety of in vitro and in vivo studies with dovitnib provided preclinical rationale for clinical evaluation of dovitinib in patients with metastatic clear cell renal cancer.
The combination of everolimus with dovitnib will target 3 major protagonists associated with tumour growth The main risks and burdens to the patients participating in the study are the potential for side effects of the trial medicines, these two drugs have not been used in combination together and although there is safety data on each drug, there is no known safety data on the drugs when used in combination. The first cohort of patients will receive 200mg of dovitnib and 5mg of everolimus. In previous studies these drugs have been administered separately and at higher doses. The maximum tolerated dose (MTD) of dovitnib for the 5-day on/ 2-day off dosing schedule has been defined as 500mg/day in a previous Phase I studies. In the RECORD-1 study (a Phase III double blind randomised trial investigating everolimus) a dose of 10mg was used.
Cohorts of three patients will be treated in each dose level. A minimum of 14 days will elapse between the first patient being treated in each cohort and entering the next patient. Further patients may be entered concurrently. Toxicity will be assessed according to NCI CTCAE v4.0; if no dose limiting toxicity (DLT) occurs dose escalation will be undertaken for the next cohort of patients.
In the event of DLT in 1out of the 3 patients the cohort will be expanded to a maximum of 6 patients. If more than or equal to 2 out of 6 patients experience DLT dose escalation will be halted and the maximum administered dose (MAD) has been reached. If less than or equal to 1 out of 6 patients had DLT dose escalation may continue.
Patients may not personally benefit from being in this study. However the information we gain from this study might help to treat future patients who have metastatic kidney cancer.
- Conditions
- Metastatic Clear Cell Renal Cancer
- Being tested
- Dovitinib, Everolimus
- Keywords
- Metastatic Clear Cell Renal Cancer Dovitinib Everolimus Cohort Maximum administered dose maximum tolerated dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DovitinibDrug
Cohort 0: 200mg, Cohort 1: 300mg, Cohort 2: 300mg, Cohort 3: 400mg, Cohort 4: 500mg. Cohort -1: 100mg
EverolimusDrug
Cohort 0: 5mg, Cohort 1: 5mg, Cohort 2: 10mg, Cohort 3: 10mg, Cohort 4: 10mg, Cohort -1: 5mg.
| Study group | Role | What they receive |
|---|---|---|
| Dovitinib and Everolimus | Other | No Arms Receives: Drug: Dovitinib; Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine and establish the safety profile of everolimus and dovitinib and define the dose limiting toxicity (DLT)
Determining causality of each adverse (AE) to everolimus and dovitinib and grading severity according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: 6 Months after all patients have come off study
To determine the maximum tolerated dose (MTD) of everolimus and dovitinib given orally in patients with VEGF resistant renal cancer
Determining the maximal dose at which no more than one patient out of up to six at that dose level experiences an almost certainly or probably drug related DLT, as defined in 3.1.4 of the protocol.
Measured: 1 month after each cohort is closed to recruitment
Secondary outcomes (3)
To evaluate clinical benefit at 6 months (Stable disease, partial response and complete response ) in the 13 assessable patients who received the maximum tolerated dose (n=13).
Response assessment (stable disease (SD), partial response (PR) or complete response (CR)) determined according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1). 50% or more clinical benefit at 6 months would be of interest
Measured: 6 months after all patients have come off study
To evaluate tumour response in the 13 patients who received the maximum tolerated dose (n=13). This includes the 7 additional assessable patients in the expansion cohort.
Response assessment will be measured by RECIST v1.1 at 6 and 14 weeks. 2 or more responses (15%) would be of interest
Measured: 6 months after all patients have come off study
To determine plasma pharmacokinetic (PK) parameters following administration of everolimus and dovitinib
Measurement of PK parameter values for both drugs on day 5 of the 1st cycle and (pre dose, and 3 hour sample).
Measured: 6 months after all patients have come off study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startApr 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Clear Cell Renal CancerStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Centre of Experimental Medicine, Queen Mary University of London
- Investigators
- Thomas Powles, MD, Principal investigator, Queen Mary Unviersity of London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714765
- Sponsor's protocol ID
- 007422QM
- Other IDs
- 2010-021250-19
- Acronym
- DEVELOP
- Status last verified
- Nov 2013
- First submitted
- 17 Oct 2012
- Last updated
- 13 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Investigating Everolimus and Dovitinib in Metastatic Clear Cell Renal Cancer
- ClinicalTrials.gov ID
- NCT01714765
- Acronym / sponsor ID
- DEVELOP / 007422QM
- Conditions
- Metastatic Clear Cell Renal Cancer
- Keywords
- Metastatic Clear Cell Renal Cancer Dovitinib Everolimus Cohort Maximum administered dose maximum tolerated dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Apr 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 26 Oct 2012 (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.
When kidney cancer spreads beyond the kidney, it is known as metastatic kidney cancer. This is very difficult to treat and almost all patients will die of their disease within 3 years.
Sunitinib has become standard therapy for untreated patients with metastatic clear cell renal (kidney) cancer. It targets a growth factor known as VEGF which is important in treating renal cancer. Although the results with this drug are impressive, patients develop resistance to the drug, relapse and die of renal cancer. It is currently standard practice is to treat patients with everolimus when resistance to sunitinib occurs; this is associated with clear clinical benefit. However the median time to progression with everolimus is 4.9 months in previously treated patients, therefore further improvement in treating patients is required. The optimal way of achieving this is to increase the efficacy of everolimus by adding agents which directly target the cause of resistance to sunitinib.
Dovitinib is a promising new drug in renal cancer. Dovitinib blocks cellular functions such as activation of downstream signalling molecules, cell proliferation and survival. Combining dovitinib and everolimus is very attractive.
This trial is aimed to establish the maximum tolerated dose for the combination of dovitinib and everolimus in clear call renal cancer, which can then be taken into a randomised phase II study.
A maximum of 30 patients will be recruited into this multi centre national trial.
Expansion Cohort:
The study has established the MAD and the MTD. The MTD was Cohort 0 (Everolimus 5mg and Dovitinib 200mg). 6 patients were recruited in this cohort with only 1 patient experiencing a DLT. A further 3 patients were recruited into Cohort 1 (Everolimus 5mg and Dovitinib 300mg), where 2 patients experienced a DLT.
A total of 7 assessable patients will be recruited during the expansion phase at the MTD (Cohort 0: Everolimus 5mg and Dovitinib 200mg) to further define the safety, tolerability, efficacy, PK and biological end points.
Assessable patients for the expansion cohort are defined as being on the study for a minimum of 6 weeks. Any patients enrolled who are not assessable will be replaced.
Detailed description
Renal cell cancer, also referred to as kidney cancer, is diagnosed in approximately 170,000 people worldwide annually, resulting in 82,000 deaths. Treatment for metastatic kidney cancer is difficult. Almost all of the patients die from their disease.
In 2006 a new drug called sunitinib, a tyrosine kinase inhibitor, transformed treatment options. It targets the development of new blood vessels within the cancer. Although the results with this drug are impressive, patients develop resistance a median after 11 months to the drug, relapse and die of renal cancer. It is currently standard practice to switch to everolimus when resistance to sunitinib occurs; this is associated with clear clinical benefit. However the median time to progression with everolimus is 4 months in previously treated patients, therefore further improvement in treating patients is required. The optimal way of achieving this is to increase the efficacy of everolimus by adding agents which directly target the cause of resistance to sunitinib.
dovitnib is a promising new drug the pharmacology data from a variety of in vitro and in vivo studies with dovitnib provided preclinical rationale for clinical evaluation of dovitinib in patients with metastatic clear cell renal cancer.
The combination of everolimus with dovitnib will target 3 major protagonists associated with tumour growth The main risks and burdens to the patients participating in the study are the potential for side effects of the trial medicines, these two drugs have not been used in combination together and although there is safety data on each drug, there is no known safety data on the drugs when used in combination. The first cohort of patients will receive 200mg of dovitnib and 5mg of everolimus. In previous studies these drugs have been administered separately and at higher doses. The maximum tolerated dose (MTD) of dovitnib for the 5-day on/ 2-day off dosing schedule has been defined as 500mg/day in a previous Phase I studies. In the RECORD-1 study (a Phase III double blind randomised trial investigating everolimus) a dose of 10mg was used.
Cohorts of three patients will be treated in each dose level. A minimum of 14 days will elapse between the first patient being treated in each cohort and entering the next patient. Further patients may be entered concurrently. Toxicity will be assessed according to NCI CTCAE v4.0; if no dose limiting toxicity (DLT) occurs dose escalation will be undertaken for the next cohort of patients.
In the event of DLT in 1out of the 3 patients the cohort will be expanded to a maximum of 6 patients. If more than or equal to 2 out of 6 patients experience DLT dose escalation will be halted and the maximum administered dose (MAD) has been reached. If less than or equal to 1 out of 6 patients had DLT dose escalation may continue.
Patients may not personally benefit from being in this study. However the information we gain from this study might help to treat future patients who have metastatic kidney cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dovitinib and Everolimus | Other | Drug: Dovitinib, Drug: EverolimusNo Arms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histopathologically confirmed clear cell renal carcinoma with measurable metastases on CT/MRI imaging (only a component of clear cell histology is required).
- Patients must have progression on or after stopping treatment with a VEGF receptor tyrosine kinase inhibitor (sunitinib and/or sorafenib)
- Prior vaccine therapy or treatment with cytokines (ie IL-2, Interferon) and/ or VEGF ligand inhibitors (bevacizumab) are permitted.
- Minimum of 18 years of age (there is no upper age limit)
- Radiological progressive disease.
Key exclusion criteria (28 listed)
- Congestive heart failure, myocardial infarction or coronary artery bypass graft in the previous six months, ongoing severe heart disease.
- Females of child-bearing potential, defined as all women physiologically capable of becoming pregnant, without exceptions, Unless; They meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 IU/l, OR; Have past 6 weeks from surgical bilateral oophorectomy with or without hysterectomy OR;
- Females are expected to use two forms of contraception. The following combinations of contraception are acceptable:
- Note: Reliable contraception must be maintained throughout the study.
- Females of child bearing potential must have a negative pregnancy test prior to starting the study. Females must not be pregnant or lactating.
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 |
|---|---|---|
| DovitinibCohort 0: 200mg, Cohort 1: 300mg, Cohort 2: 300mg, Cohort 3: 400mg, Cohort 4: 500mg. Cohort -1: 100mg | Drug | Dovitinib and Everolimus |
| EverolimusCohort 0: 5mg, Cohort 1: 5mg, Cohort 2: 10mg, Cohort 3: 10mg, Cohort 4: 10mg, Cohort -1: 5mg. | Drug | Dovitinib and Everolimus |
Primary outcome
To determine and establish the safety profile of everolimus and dovitinib and define the dose limiting toxicity (DLT)
Time frame: 6 Months after all patients have come off study
Determining causality of each adverse (AE) to everolimus and dovitinib and grading severity according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
To determine the maximum tolerated dose (MTD) of everolimus and dovitinib given orally in patients with VEGF resistant renal cancer
Time frame: 1 month after each cohort is closed to recruitment
Determining the maximal dose at which no more than one patient out of up to six at that dose level experiences an almost certainly or probably drug related DLT, as defined in 3.1.4 of the protocol.
3 secondary outcomes
To evaluate clinical benefit at 6 months (Stable disease, partial response and complete response ) in the 13 assessable patients who received the maximum tolerated dose (n=13).
Time frame: 6 months after all patients have come off study
To evaluate tumour response in the 13 patients who received the maximum tolerated dose (n=13). This includes the 7 additional assessable patients in the expansion cohort.
Time frame: 6 months after all patients have come off study
To determine plasma pharmacokinetic (PK) parameters following administration of everolimus and dovitinib
Time frame: 6 months after all patients have come off study
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 13 Nov 2013.
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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.
Thomas Powles, MD principal investigator
Queen Mary Unviersity of London, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dovitinib and Everolimus in people with Metastatic Clear Cell Renal Cancer, run by Queen Mary University of London at 1 site in United Kingdom.
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 17 inclusion and 28 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 13 Nov 2013. 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 United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To determine and establish the safety profile of everolimus and dovitinib and define the dose limiting toxicity (DLT) (time frame: 6 Months after all patients have come off study). The study lists 2 primary outcomes in all. 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 13 Nov 2013.