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

In this study, the experimental study drug denosumab is evaluated for the
treatment of patients with Giant Cell Tumor of the bone. Denosumab might stop
the cells that destroy bone and it might help repair the destroyed bone.
Denosumab is being tested to see if it stops the damage to bones caused by the
Giant Cell Tumor. Denosumab is not approved by any regulatory organization.
The number of subjects in this study will depend on the number of patients that
qualify for this study. It is anticipated that approximately 50 hospitals will
enroll subjects to this study
Amgen Inc. is funding this clinical study.

The objective of the study is to evaluate the safety profile of denosumab in
subjects with Giant Cell Tumor of bone.

An open-label, multicenter, phase 2 study.
The study consists of 3 parts. The first part is the screening. If the patient
is eligible for the study, he/she will go into the treatment phase and this
phase lasts until the patient is not longer benefiting from this treatment or
till 6 months after the operation. The patient will be followed for safety for
12 months after the treatment phase.
Each subject participating in this study will receive 1 of the following
treatments:
1) patients who are unsalvageable: denosumab 120 mg SC Q4W with a loading dose
at study days 8 and 15. Treatment as long as the patient has clinical benifit
from the treatment.
2) patients who are salvageable: denosumab 120 mg SC Q4W with a loading dose at
study days 8 and 15. If the patient has a CR/PR after the operation the patient
will receive treatment for 6 months.

All participating patients will receive denosumab 120 mg SC Q4W with a loading
dose on days 8 and 15.

The patient is being asked to come to the hospital twice during the screening
period. The estimated duration of the treatment is 12 months. Patients are
being asked to come to the hospital every month and extra on days 8 and 15.
Study visits will last about 1 hour.
The risks of participation are small. All patients will receive denosumab and
therefore have a change on a possible positive effect of denosumab. The
treatment options for this patient population are small.
When the patient does not benefit on the treatment with denosumab and if there
are situations that are not acceptable (for the patient or the investigator)
the patient can always stop with the study.