Efficacy and Safety of Systemic Treatments of Bone Metastases From Kidney Cancer in Patients Treated With Targeted Therapies

NCT03408652 | Terminated Phase 3 DMC

• 2 other identifiers: MOSCAR2017-004075-31
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Multicenter, randomized, open-label, 2-arm, parallel-group, phase III study whose goal is to assess the efficacy and safety profile of bone-targeted treatments (Arm A: denosumab or zoledronic acid) versus the control arm (Arm B: no specific treatment) in patients with bone metastases under targeted therapy for Metastatic Renal Cell Carcinoma.

Conditions

Metastatic Renal Cell Carcinoma

Keywords

Bone Metastases

Outcome Measures

Primary Outcomes (1)

• Time to first Skeletal Related Event

  Defined as the time from randomization to first SRE. Patients without event will be censored at the time of the last clinical evaluation.

  Up to 54 months after the first inclusion

Secondary Outcomes (11)

• Number of specific event-free survivals

  Up to 54 months after the first inclusion

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Every 3 months until the 18th month for each patient

• Evolution of pain severity

  Every 3 months until the 18th month for each patient

• Evolution of pain

  Every 3 months until the 18th month for each patient

• Patient's condition evaluation

  Up to 9 months for each patient (evaluated at baseline, months 3, 6, 9)

Study Arms (2)

Arm A

EXPERIMENTAL

bone targeted treatment (denosumab or zoledronic acid)

Drug: denosumab

Arm B

NO INTERVENTION

no specific treatment

Interventions

denosumab DRUG

Single subcutaneous injection of denosumab 120 mg every 4 weeks One intravenous infusion of zoledronic acid 4 mg every 4 weeks, according to labelled use.

Also known as: zoledronic acid

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Histologically proven mRCC.
• Administration of one of the systemic agents in use for the treatment of mRCC (no more than three prior systemic therapy regimens). Patients with at least 6 months of 1st line treatment and a bone event may be included.
• More than 1 bone metastasis.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.
• Adequate renal function (serum creatinine ≤ 200 mmol/L or creatinine clearance ≥ 30 mL/min according to Cockroft formula or MDRD formula for patients older than 65 years).
• Covered by a medical insurance.
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
• Signed informed consent.
• Accepting to use effective contraception during study treatment and within 5 months after final dose of study therapy.

You may not qualify if:

• Imminent or ongoing nerve or spinal compression as per the investigator's judgement.
• Ongoing first-line therapy, started for less than 6 months (patients with BM at time of metastases diagnosis will initially benefit from the angiogenesis targeted agents used and are not at higher risk).
• Anticancer treatment under investigation.
• Paraneoplastic hypercalcemia (corrected total calcium \> 2.7 mmol/L).
• Grade 4 toxicity under previous targeted agents.
• Liver failure (AST and/or ALT ≥ 5.0 x upper limit of normal (ULN) or total bilirubin beyond normal limits).
• Severe hypocalcaemia \> 2.8 mmol/l.
• Fructose intolerance.
• Psychological, familial, sociological, geographical conditions that would limit compliance with study protocol requirements.
• Life expectancy ≤ 3 months.
• Participation to another clinical trial that might interfere with the evaluation of the main criterion.
• Known hypersensitivity to the active substance or to any of the excipients of bisphosphonate or denosumab.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Leon Berard

Lyon, 69008, France

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Denosumab; Zoledronic Acid

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sylvie NEGRIER, PhD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 24, 2018
• Study Start: March 15, 2019
• Primary Completion: June 22, 2020
• Study Completion: June 22, 2020
• Last Updated: October 22, 2021

Record last verified: 2021-10

Locations

FR (1)