Phase II, multicenter, randomized, open-label study with MAP +/- denosumab regimen for the treatment of patients with metastatic osteosarcoma

Phase 1

• Conditions: Metastatic osteosarcoma; MedDRA version: 21.1Level: PTClassification code 10031294Term: Osteosarcoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-002366-41-IT
• Lead Sponsor: ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-18
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

- High-grade metastatic osteosarcoma
- Age at diagnosis = 12 years (or with skeletal maturity) and = 40 years
- ECOG Performance status = 2 or Lansky = 40%
- Adequate medullary, cardiac, liver and kidney function
- Female subjects of childbearing age must perform a pregnancy test before entering the study
- Written informed consent obtained from the patient/parent/legal representative
Are the trial subjects under 18? yes
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 56
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Medical contraindication to the use of the drugs provided for in the study
- Previous treatments with denosumab or other biphosphonates
- Mental or social conditions that do not guarantee adequate compliance with the protocol, proper home management of toxicity or an adequate understanding of participation in the study
- Lack of written informed consent
- Organ dysfunction
- Pregnancy or lactation
- Uncontrolled hypocalcemia with oral calcium supplementation
- Severe hypovitaminosis D
- Previous history or evidence of osteonecrosis of the jaw
- Dental contraindications to the use of denosumab

Study & Design

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