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Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer


Phase 3
18 Years
N/A
Open (Enrolling by invite only)
Both
Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer

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Trial Information

Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer


Inclusion Criteria:



- Subject was previously enrolled in a denosumab phase 3 study and participated in the
Open-label Extension portion of that study.

- Subject or subject's legally acceptable representative has provided informed consent.

Exclusion Criteria:

- Subject is of child bearing potential and planning to become pregnant within 7 months
after the end of treatment.

- Subject is of child bearing potential and is not willing to use, in combination with
her partner, two highly effective methods of contraception during treatment and for 7
months after the end of treatment.

- Subject has known sensitivity to any of the products to be administered during
dosing.

- Subject will not be available for protocol required study visits or procedures, to
the best of the subject and investigator's knowledge.

- Subject has any kind of disorder that, in the opinion of the investigator, may
compromise the ability of the subject to give written informed consent and/or to
comply with all required study procedures.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Subject incidence of treatment-emergent adverse events

Outcome Time Frame:

Study duration (expected to be approximately 1 year per subject)

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Australia: Therapeutic Goods Administration

Study ID:

20110113

NCT ID:

NCT01419717

Start Date:

November 2011

Completion Date:

December 2014

Related Keywords:

  • Bone Metastases in Men With Hormone-Refractory Prostate Cancer
  • Bone Metastases in Subjects With Advanced Breast Cancer
  • cancer
  • bone metastases
  • breast cancer
  • prostate cancer
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases

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