Clear-cell Metastatic Renal Cell CarcinomaPhase 1/2EIFFELNCT02880943
Dose-finding, Safety and Efficacy Study of Radium-223 Dichloride (XOFIGO) in RCC Patients With Bone Metastases. (EIFFEL)
A Phase 1/2 study testing XOFIGO in people with Clear-cell Metastatic Renal Cell Carcinoma and Bone Metastases, run by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie at 5 sites in France.
Trial summary
This is a prospective, multicentre, open-label, phase I/II study to evaluate the maximum tolerated dose (MTD), and the most successful dose (MSD) of XOFIGO®, in renal cancer patients with metastases to bone, without (Group A) or with (Group B) visceral metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear-cell Metastatic Renal Cell Carcinoma, Bone Metastases
- What is being tested?
- XOFIGO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 5 sitesFrance
- Study dates
- Oct 2016to Feb 2021
- Phase
- Phase 1/2
- 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
- Histologically confirmed metastatic renal cell carcinoma with a clear cell component.
- Bone metastases upon bone scan with no CT and MRI performed any time within period of 4 weeks prior to study entry, with at least one evaluable unidimensional bone lesion (i.e., ≥1 malignant tumour mass that can be accurately measured in at least 1 dimension ≥ 10 mm on T1-weighted Magnetic Resonance Imaging [MRI]).
- Group A: bone metastases (lymph nodes and/or adrenal metastases, and/or ≤ 5 lung metastases of less than 1 cm each, are allowed).
- Group B: bone metastases AND visceral metastases upon MRI (according to revised RECIST 1.1 criteria).
- Patient in a) first (naïve), or b) second or third line setting receiving or about to receive an approved Tyrosine Kinase Inhibitor (patients on mTOR inhibitors are not eligible).
- Male or female, age ≥18 years at ICF signature time.
Show all 23Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Good or Intermediate prognostic group according to the International Metastatic Database Consortium (IMDC).
- At least 4 weeks from the end of a previous systemic treatment, if any, with resolution of all treatment-related toxicity according to NCI CTCAE Version 4.03 grade ≤ 1 except for alopecia.
- Palliative local treatment allowed if performed ≥ 2 weeks prior to study entry for radiotherapy, cementoplasty or minor surgery; ≥ 4 weeks prior to study entry for major surgery.
- Adequate organ function defined by the following criteria:
- Absolute Neutrophils count (ANC) ≥1 500 cells/mm3
- Platelets ≥100 000 cells/mm3
- Haemoglobin ≥ 9.0 g/dL
- AST and ALT ≤ 2.5 x upper limit of normal (ULN), unless there are liver metastases in which case AST and ALT ≤5.0 x ULN
- Total bilirubin ≤ 1.5 x ULN
- Estimated glomerular filtration rate upon MDRD ≥ 50 mL/min
- Urinary protein < 2+ by urine dipstick. If dipstick is ≥ 2+ then a 24-hour urine collection can be done and the patient may enter only if urinary protein is < 2 g per 24 hours
- Corrected calcium ≤ 2.8 mmol/L.
- Women of childbearing potential must have a negative serum pregnancy test within 7days prior to treatment initiation.
- Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrolment.
- Willingness, for men and women,to use effective contraception during study treatment and for 6 months after last dose of study drug.
- Willingness to comply with protocol requirements.
Who cannot join
- Poor prognostic group according to the IMDC. 2. Prior radiotherapy to ≥ 40% of bone marrow, whole pelvic irradiation and/or prior isotope therapy whatever the isotope (any α- or β-emitters).
- 3. Active secondary cancer including prior malignancy from which the subject has been disease-free for ≤ 3 years (however, adequately treated superficial basal cell skin or cervical carcinoma in situ before 4 weeks prior to entry are eligible to the study).
- 4. Known brain or leptomeningeal involvement. 5. Any other concurrent serious illness or medical conditions including:
- Crohn"s disease or ulcerative colitis
- Bone marrow dysplasia
- Known presence of osteonecrosis of the jaw 6. Uncontrolled hypertension. 7. Uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension. History of congestive heart failure, or myocardial infarction within the last 6 months.
Show all 11Show fewer
- 8. QTc interval (QTc) assessed by local device > 500ms in the 7 days prior to inclusion.
- 9. Ongoing biphosphonates, denosumab and/or vitamin D supplementation. 10. Active infection requiring systemic antibiotic or anti-fungal medication. 11. Any contra-indication to MRI, including:
- Carrying a metallic medical device (e.g. pacemaker) or foreign body prohibiting use of MRI
- Known allergy to gadolinium or iodine
- Dysthyroidism precluding usage of iodine contrast agent 12. Pregnant or breast feeding. 13. Participation in another clinical trial with any investigational drug within 30 days prior to study enrolment.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU Bordeaux (St. André)
Bordeaux, 33000
Centre François Baclesse
Caen, 14000
Hôpital Cochin
Paris, 75014
Hopital Europeen Georges Pompidou
Paris, 75015
Institut Gustave Roussy
Villejuif, 94805 cedex
About this study
Official title: Phase I/II Dose-finding, Safety and Efficacy Study of Radium-223 Dichloride (XOFIGO®) in Renal Cell Carcinoma Patients With Bone Metastases.
This is a prospective, multicentre, open-label, phase I/II study to evaluate the maximum tolerated dose (MTD), and the most successful dose (MSD) of XOFIGO®, in renal cancer patients with metastases to bone, without (Group A) or with (Group B) visceral metastases.
Read the detailed description
This is a prospective, multicentre, open-label, phase I/II study to evaluate the maximum tolerated dose (MTD), and the most successful dose (MSD) of XOFIGO®, in renal cancer patients with metastases to bone, without (Group A) or with (Group B) visceral metastases.
Dose-finding will be performed according to the Continual Reassessment Method (CRM) using either toxicity (escalation cohort) or joined toxicity-efficacy (expansion cohort) endpoints.
Two groups of patients will be evaluated:
- Group A: patients with bone disease mainly will be treated with XOFIGO® alone. (node and/or adrenal metastases and/or ≤5 lung metastases ≤1cm each are allowed in Group A).
- Group B: patients already treated with an ongoing approved Tyrosine Kinase Inhibitor (TKI) for their visceral metastases will be treated with XOFIGO® for bone disease.
XOFIGO® will be administered intravenously as a bolus injection every 4 weeks with a maximum of 6 administrations per patient. Four dose levels are available for evaluation : 27.5 kBq/kg, 55 kBq/kg, 88 kBq/kg and 110 kBq/kg.
Starting dose for phase I will be 55 kBq/kg.
Visit schedule:
Selection Patients will come to the hospital at baseline, and screening assessments must be performed within 28 days prior to first XOFIGO® administration.
XOFIGO® period Patients will receive an injection of XOFIGO® on Day 1 of each 4 weeks-cycle for a maximum of 6 cycles. Patients will be subject to physical examination, blood sampling and pain evaluation prior to each injection. Scintigraphy of biodistribution of radium-223 dichloride will be realised on C1D1 after the 1st injection of XOFIGO® On C1D15, patients will also come for physical examination and blood sampling. On C2D15 (end of DLT period for phase I), patients will also come for end of DLT period evaluation and will be subject to physical examination and blood sampling.
Prior to C3D1 and C5D1, patients will undergo WB-IRM and FNa-PET. End of treatment visit (EOT) will take place 4 weeks after the last administration of XOFIGO®.
In the absence of confirmed bone progression at XOFIGO® discontinuation time, patients will continue to undergo WB-IRM and FNa-PET every 2 months until confirmed bone progression or end of follow-up.
Confirmation of bone progression upon WB-IRM will be performed 4 weeks after the initial progression is observed.
Follow-up Patients will be followed-up for a maximum of 12 months from the 1st administration of XOFIGO®.
Number of subjects:
Maximum number of patients to be enrolled in the escalation cohort is 21. Maximum number of patients to be enrolled in the expansion cohort is 21. Group A: 2-4 patients; Group B: 38-40 patients.
- Being tested
- XOFIGO
- Medical subject headings
- Clear-cell metastatic renal cell carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XOFIGODrug
Also called radium-223
XOFIGO® will be administered intravenously as a bolus injection every 4 weeks with a maximum of 6 administrations per patient.
Four dose levels are available for evaluation : 27.5 kBq/kg, 55 kBq/kg, 88 kBq/kg and 110 kBq/kg.
Starting dose for phase I will be 55 kBq/kg.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A: patients with bone disease mainly will be treated with XOFIGO® alone.
Node and/or adrenal metastases and/or ≤5 lung metastases ≤1cm each are allowed in Group A. Receives: Drug: XOFIGO |
| Group B | Experimental | Group B: patients already treated with an ongoing approved Tyrosine Kinase Inhibitor (TKI) for their visceral metastases will be treated with XOFIGO® for bone disease. Receives: Drug: XOFIGO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities (DLT)
Dose-limiting toxicities (DLT) within the first 6 weeks to determine the MTD.
DLT is defined as any XOFIGO related adverse event occurring between C1D1 and C2D15.
Measured: within 6 weeks after the first injection of XOFIGO
Secondary outcomes (12)
Distribution of radium-223 dichloride into the bone assessed with scintigraphy of biodistribution of radium-223 dichloride
Distribution of radium-223 dichloride into the bone assessed with scintigraphy of biodistribution of radium-223 dichloride
Measured: Assessed at day 1 after the first Xofigo injection
Bone response concordance between FNa-PET scan and whole-body MRI
Measured: up to 12 months
Bone clinical benefit rate (bone objective response or stable disease, BCB)
Measured: up to 12 months
Overall clinical benefit rate (bone and visceral objective response or stable disease, OCB)
Measured: up to 12 months
Changes in bone markers
Changes in bone markers: bone formation: bone alkaline phosphatase [bALP], N-terminal type I collagen [PINP]; bone resorption: C-terminal telopeptide cross-linking of type I collagen [S-CTX-I], cross-linked C-terminal telopeptide of type I collagen [ICTP]), TRACP 5b, sRANKL, osteoprotegerin (OPG)
Measured: up to 12 months
Time to occurrence of the first Skeletal-Related Events (SRE)
SRE including pathological fracture, requirement to initiate radiotherapy, spinal cord compression or requirement for bone surgery
Measured: up to 12 months
Time to bone progression (TTBP) defined as the time from the first administration of XOFIGO® to the bone tumour progression (revised RECIST 1.1 taking into account bone lesions)
Measured: up to 12 months
1-year overall survival rate (1y-OS) defined as the percentage of patients alive 1 year after 1st administration of XOFIGO®
Measured: 1 year
Pain assessment upon Brief Pain Inventory (BPI) and analgesic consumption questionnaire
Measured: BPI questionnaire will be completed 7 days before the first administration of XOFIGO® and before each visit.
Change From Baseline in the FACT-Kidney Symptom Index-15 (FKSI-15) Scale
FKSI-15 questionnaire will be performed only for patients included in the phase II part of the study.
Measured: 7 months (Baseline and at 7 months)
Changes in MRI
New MRI criteria as prediction markers for progression and for disease specific and overall survival:
Diffusion weighted imaging (DWI): Apparent diffusion coefficient (ADC) values in the five target bone lesions
- Ultra-short echo time (UTE) sequence: T2 measurements in the five target bone lesions
- Perfusion weighted imaging (PWI): assessments of the area under the curve at 1min30, and of the focal lesion (FLE max) enhancement.
Measured: up to 12 months
Change From Baseline in EQ-5D Scale
EQ-5D questionnaire will be performed only for patients included in the phase II part of the study.
Measured: 7 months (Baseline and at 7 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear-cell 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephane OUDARD, MD, Principal investigator, Hôpital Européen Georges Pompidou, Oncology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880943
- Sponsor's protocol ID
- EIFFEL
- Acronym
- EIFFEL
- Status last verified
- Nov 2016
- First submitted
- 18 Aug 2016
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Dose-finding, Safety and Efficacy Study of Radium-223 Dichloride (XOFIGO®) in Renal Cell Carcinoma Patients With Bone Metastases.
- ClinicalTrials.gov ID
- NCT02880943
- Acronym / sponsor ID
- EIFFEL / EIFFEL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Association Pour La Recherche des Thérapeutiques Innovantes en CancérologieUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 26 Aug 2016 (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.
This is a prospective, multicentre, open-label, phase I/II study to evaluate the maximum tolerated dose (MTD), and the most successful dose (MSD) of XOFIGO®, in renal cancer patients with metastases to bone, without (Group A) or with (Group B) visceral metastases.
Detailed description
This is a prospective, multicentre, open-label, phase I/II study to evaluate the maximum tolerated dose (MTD), and the most successful dose (MSD) of XOFIGO®, in renal cancer patients with metastases to bone, without (Group A) or with (Group B) visceral metastases.
Dose-finding will be performed according to the Continual Reassessment Method (CRM) using either toxicity (escalation cohort) or joined toxicity-efficacy (expansion cohort) endpoints.
Two groups of patients will be evaluated:
- Group A: patients with bone disease mainly will be treated with XOFIGO® alone. (node and/or adrenal metastases and/or ≤5 lung metastases ≤1cm each are allowed in Group A).
- Group B: patients already treated with an ongoing approved Tyrosine Kinase Inhibitor (TKI) for their visceral metastases will be treated with XOFIGO® for bone disease.
XOFIGO® will be administered intravenously as a bolus injection every 4 weeks with a maximum of 6 administrations per patient. Four dose levels are available for evaluation : 27.5 kBq/kg, 55 kBq/kg, 88 kBq/kg and 110 kBq/kg.
Starting dose for phase I will be 55 kBq/kg.
Visit schedule:
Selection Patients will come to the hospital at baseline, and screening assessments must be performed within 28 days prior to first XOFIGO® administration.
XOFIGO® period Patients will receive an injection of XOFIGO® on Day 1 of each 4 weeks-cycle for a maximum of 6 cycles. Patients will be subject to physical examination, blood sampling and pain evaluation prior to each injection. Scintigraphy of biodistribution of radium-223 dichloride will be realised on C1D1 after the 1st injection of XOFIGO® On C1D15, patients will also come for physical examination and blood sampling. On C2D15 (end of DLT period for phase I), patients will also come for end of DLT period evaluation and will be subject to physical examination and blood sampling.
Prior to C3D1 and C5D1, patients will undergo WB-IRM and FNa-PET. End of treatment visit (EOT) will take place 4 weeks after the last administration of XOFIGO®.
In the absence of confirmed bone progression at XOFIGO® discontinuation time, patients will continue to undergo WB-IRM and FNa-PET every 2 months until confirmed bone progression or end of follow-up.
Confirmation of bone progression upon WB-IRM will be performed 4 weeks after the initial progression is observed.
Follow-up Patients will be followed-up for a maximum of 12 months from the 1st administration of XOFIGO®.
Number of subjects:
Maximum number of patients to be enrolled in the escalation cohort is 21. Maximum number of patients to be enrolled in the expansion cohort is 21. Group A: 2-4 patients; Group B: 38-40 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: XOFIGOGroup A: patients with bone disease mainly will be treated with XOFIGO® alone. Node and/or adrenal metastases and/or ≤5 lung metastases ≤1cm each are allowed in Group A. |
| Group B | Experimental | Drug: XOFIGOGroup B: patients already treated with an ongoing approved Tyrosine Kinase Inhibitor (TKI) for their visceral metastases will be treated with XOFIGO® for bone disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Histologically confirmed metastatic renal cell carcinoma with a clear cell component.
- Bone metastases upon bone scan with no CT and MRI performed any time within period of 4 weeks prior to study entry, with at least one evaluable unidimensional bone lesion (i.e., ≥1 malignant tumour mass that can be accurately measured in at least 1 dimension ≥ 10 mm on T1-weighted Magnetic Resonance Imaging [MRI]).
- Group A: bone metastases (lymph nodes and/or adrenal metastases, and/or ≤ 5 lung metastases of less than 1 cm each, are allowed).
- Group B: bone metastases AND visceral metastases upon MRI (according to revised RECIST 1.1 criteria).
- Patient in a) first (naïve), or b) second or third line setting receiving or about to receive an approved Tyrosine Kinase Inhibitor (patients on mTOR inhibitors are not eligible).
Key exclusion criteria (11 listed)
- Poor prognostic group according to the IMDC. 2. Prior radiotherapy to ≥ 40% of bone marrow, whole pelvic irradiation and/or prior isotope therapy whatever the isotope (any α- or β-emitters).
- 3. Active secondary cancer including prior malignancy from which the subject has been disease-free for ≤ 3 years (however, adequately treated superficial basal cell skin or cervical carcinoma in situ before 4 weeks prior to entry are eligible to the study).
- 4. Known brain or leptomeningeal involvement. 5. Any other concurrent serious illness or medical conditions including:
- Crohn"s disease or ulcerative colitis
- Bone marrow dysplasia
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 |
|---|---|---|
| XOFIGOAlso: radium-223XOFIGO® will be administered intravenously as a bolus injection every 4 weeks with a maximum of 6 administrations per patient. Four dose levels are available for evaluation : 27.5 kBq/kg, 55 kBq/kg, 88 kBq/kg and 110 kBq/kg. Starting dose for phase I will be 55 kBq/kg. | Drug | Group A, Group B |
Primary outcome
Dose-limiting toxicities (DLT)
Time frame: within 6 weeks after the first injection of XOFIGO
Dose-limiting toxicities (DLT) within the first 6 weeks to determine the MTD. DLT is defined as any XOFIGO related adverse event occurring between C1D1 and C2D15.
12 secondary outcomes
Distribution of radium-223 dichloride into the bone assessed with scintigraphy of biodistribution of radium-223 dichloride
Time frame: Assessed at day 1 after the first Xofigo injection
Bone response concordance between FNa-PET scan and whole-body MRI
Time frame: up to 12 months
Bone clinical benefit rate (bone objective response or stable disease, BCB)
Time frame: up to 12 months
Overall clinical benefit rate (bone and visceral objective response or stable disease, OCB)
Time frame: up to 12 months
Changes in bone markers
Time frame: up to 12 months
Time to occurrence of the first Skeletal-Related Events (SRE)
Time frame: up to 12 months
Time to bone progression (TTBP) defined as the time from the first administration of XOFIGO® to the bone tumour progression (revised RECIST 1.1 taking into account bone lesions)
Time frame: up to 12 months
1-year overall survival rate (1y-OS) defined as the percentage of patients alive 1 year after 1st administration of XOFIGO®
Time frame: 1 year
Pain assessment upon Brief Pain Inventory (BPI) and analgesic consumption questionnaire
Time frame: BPI questionnaire will be completed 7 days before the first administration of XOFIGO® and before each visit.
Change From Baseline in the FACT-Kidney Symptom Index-15 (FKSI-15) Scale
Time frame: 7 months (Baseline and at 7 months)
Changes in MRI
Time frame: up to 12 months
Change From Baseline in EQ-5D Scale
Time frame: 7 months (Baseline and at 7 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Individual participant dataSharing planned: No
Related trials for Clear-cell Metastatic Renal Cell Carcinoma
Active, not recruitingPhase 1/2
Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer
RecruitingPhase 2
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Metastatic Melanoma, Advanced Locoregional Melanoma
RecruitingPhase 1
Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
RecruitingPhase 1/2
A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors
Metastatic Castration-Resistant Prostate Cancer (mCRPC), Clear Cell Renal Cell Carcinoma (ccRCC)
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.
Stephane OUDARD, MD principal investigator
Hôpital Européen Georges Pompidou, Oncology Department
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing XOFIGO in people with Clear-cell Metastatic Renal Cell Carcinoma and Bone Metastases, run by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie at 5 sites 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 23 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 combined 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.
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?
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?
Dose-limiting toxicities (DLT) (time frame: within 6 weeks after the first injection of XOFIGO). 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 8 Nov 2016.