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Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: GCT; Giant Cell Tumor of Bone

Intervention: Denosumab (Biological); Calcium/Vitamin D (Dietary Supplement)

Phase: Phase 2

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Summary

To determine how safe and effective denosumab is in treating patients with giant cell tumor of bone.

Clinical Details

Official title: An Open-Label, Multi-Center, Phase 2 Safety and Efficacy Study of Denosumab (AMG 162) in Subjects With Recurrent or Unresectable Giant Cell Tumor (GCT) of Bone

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Participants With Giant Cell Tumor Response

Secondary outcome:

Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine

Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)

Serum Denosumab Trough Concentrations

Number of Participants With Adverse Events (AEs)

Number of Participants With Anti-Denosumab Antibodies

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adults, 18 years and older

- Histologically confirmed and measurable giant cell tumor (GCT)

- Recurrent GCT confirmed by radiology or unresectable GCT

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Exclusion Criteria:

- Pateints for whom surgery to the affected limb/area is planned within 27 days after

receiving 1st dose of denosumab

- Radiation to affected region within 28 days before enrollment to study

- Known diagnosis of osteosarcoma or brown tumor of bone

- Known history of second malignancy within the past 5 years, except for basal cell

carcinoma or cervical carcinoma in situ

- Concurrent treatment with bisphosphonates, calcitonin, or interferon.

Other criteria also apply.

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Related publications:

Branstetter DG, Nelson SD, Manivel JC, Blay JY, Chawla S, Thomas DM, Jun S, Jacobs I. Denosumab induces tumor reduction and bone formation in patients with giant-cell tumor of bone. Clin Cancer Res. 2012 Aug 15;18(16):4415-24. doi: 10.1158/1078-0432.CCR-12-0578. Epub 2012 Jun 18.

Thomas D, Henshaw R, Skubitz K, Chawla S, Staddon A, Blay JY, Roudier M, Smith J, Ye Z, Sohn W, Dansey R, Jun S. Denosumab in patients with giant-cell tumour of bone: an open-label, phase 2 study. Lancet Oncol. 2010 Mar;11(3):275-80. doi: 10.1016/S1470-2045(10)70010-3. Epub 2010 Feb 10.

Starting date: July 2006
Last updated: July 11, 2014

Page last updated: August 23, 2015

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