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Clinical Trials/EUCTR2016-005244-42-NL
EUCTR2016-005244-42-NLActive, not recruitingPhase 1

An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects with Giant Cell Rich Tumors of Bone.

eiden University Medical Center0 sites60 target enrollmentStarted: January 25, 2018Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
60
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •The population will consist of patients with the following tumor types:
  • •- Pathologically proven giant cell rich tumor
  • •Other giant cell rich lesions (primary bone, non-malignant, pathology and radiology to be reviewed during multidisciplinary meeting LUMC)
  • •- Patients with surgically unsalvageable disease (e.g., sacral, spinal giant cell rich tumors, or multiple lesions including pulmonary metastases) OR patients whose planned surgery includes joint resection, limb amputation, hemipelvectomy or surgical procedure resulting in severe morbidity
  • •- Measurable evidence of active disease within 1 year before study enrollment
  • •- Albumin-adjusted serum calcium level = 2.0 mmol/L (8.0 mg/dL)
  • •- Aged 18 years and up and skeletally mature
  • •- ECOG performance status 0, 1 or 2
  • •- Written signed informed consent
  • •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 55
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

  • •- Known or suspected current diagnosis of classic GCTB
  • •- Known or suspected current diagnosis of underlying malignancy including but not limited to high-grade sarcoma, osteosarcoma, fibrosarcoma, malignant giant cell sarcoma
  • •- Known or suspected current diagnosis of brown cell tumor of hyperparathyroidism, Paget’s disease or cherubism
  • •- Known or suspected current diagnosis of primary soft tissue tumor with invasion of the bone
  • •- Known diagnosis of other malignancy within the past 5 years (patients with definitively treated basal cell carcinoma and cervical carcinoma in situ are permitted)
  • •- Previous treatment with denosumab (with the exception of patients eligible for re-treatment with denosumab after completing this study)
  • •- Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
  • •- Active dental or jaw condition which requires oral surgery, including tooth extraction
  • •- Non-healed dental/oral surgery
  • •- Planned invasive dental procedure for the course of the study
  • •- Known hypersensitivity to denosumab
  • •- Known hypersensitivity to products to be administered during the study (calcium and/or vitamin D)
  • •- Currently receiving other specific treatment for giant cell rich tumors of bone (e.g., radiation, chemotherapy or embolization)
  • •- Concurrent bisphosphonate treatment
  • •- Major surgery less than 4 weeks prior to start of treatment
  • •- Treatment with other investigational device or drug 30 days prior to study enrollment
  • •- Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before study enrollment
  • •- Patient is pregnant or breast feeding, or planning to become pregnant within 5 months after the EOT visit
  • •- Patient, or partner of patient, of child bearing potential is not willing to use a highly effective method of contraception during treatment and for 5 months after the EOT visit
  • •- Patient has any kind of disorder that compromises the ability of the patient to give written informed consent and/or to comply with study procedures

Investigators

Sponsor
eiden University Medical Center

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