Evaluation study of tolerance and efficacy of a treatment with radium-223 in patients with clear cell renal cell carcinoma with bone metastases.

Phase 1

• Conditions: Renal cell carcinoma patients with bone metastases, with or without visceral metastases.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-003774-16-FR
• Lead Sponsor: A.R.T.I.C. (Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie )

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-19
• Last Update Posted: 4 July 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients eligible for inclusion in this study have to meet the following criteria:

1.Histologically confirmed metastatic RCC with a clear cell component..
2.Bone metastases upon bone scan 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 or CT-scan (according to revised RECIST 1.1 criteria).
3.Naïve patient (first line setting) or patient with disease progression on last therapy (second or third line setting).
4.Male or female, age =18 years at ICF signature time.
5.ECOG performance status of 0 or 1.
6.Good or Intermediate prognostic group according to the International Metastatic Database Consortium (IMDC).
7.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.
8.Palliative local treatment allowed if performed = 2 weeks prior to study entry for radiotherapy, cimentoplasty or minor surgery; = 4 weeks prior to study entry for major surgery.
9.Adequate organ function defined by the following criteria:
a.Absolute Neutrophils count (ANC) =1 500 cells/mm3
b.Platelets =100 000 cells/mm3
c.Haemoglobin = 9.0 g/dL
d.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
e.Total bilirubin = 1.5 x ULN
f.Serum creatinine = 1.5 x ULN or calculated creatinine clearance = 50 mL/min
g.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
h.Corrected calcium = 2.8 mmol/L.
10.Women of childbearing potential must have a negative serum pregnancy test within 7days prior to treatment initiation.
11.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.
12.Willingness to comply with protocol requirements, including effective contraception during study treatment and for 6 months after last dose of study drug.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1.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 a- or ß-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.Other concurrent serious illness or medical conditions.
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.
8.QTc interval (QTc) assessed by local device > 500ms in the 7 days prior to inclusion.
9.Biphosphonates, denosumab and/or vitamin D supplementation received within 2 weeks before the first injection of XOFIGO®.
10.Active infection requiring systemic antibiotic or anti-fungal medication.
11.Participation in another clinical trial with any investigational drug within 30 days prior to study enrolment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified