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An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab in the Treatment of Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma


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

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Trial Information

An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab in the Treatment of Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma


Inclusion Criteria:



- Subjects currently enrolled in study 20050103, 20050136, or 20050244

- Subjects must sign the informed consent before any study specific procedures are
performed

Exclusion Criteria:

- Developed sensitivity to mammalian cell derived drug products during the 20050103,
20050136, or 20050244 study

- Currently receiving any unapproved investigational product other than denosumab

- Subject is pregnant or breast feeding, or planning to become pregnant within 7 months
after the end of treatment

- Subject (male or female) is not willing to use 2 highly effective contraception
during treatment and for 7 months (women) or 10 months (men) after the end of
treatment

- Male subject with a pregnant partner who is not willing to use a condom during
treatment and for additional 10 months after the end of treatment

- Any disorder that, in the opinion of the investigator, may compromise the ability of
the subject to give written informed consent and/or comply with study procedures

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received either zoledronic acid (Zometa®) or denosumab.

Outcome Time Frame:

Two years

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Czech Republic: Statni ustav pro kontrolu leciv

Study ID:

20080540

NCT ID:

NCT00950911

Start Date:

July 2009

Completion Date:

February 2012

Related Keywords:

  • Bone Metastases in Men With Hormone-Refractory Prostate Cancer
  • Bone Metastases in Subjects With Advanced Breast Cancer
  • Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma
  • Bone metastases
  • Hormone-refractory prostate cancer
  • Multiple myeloma
  • Denosumab
  • Breast cancer
  • 20050103
  • 20050136
  • 20050244
  • Advanced cancer
  • Tumor
  • Prostate cancer
  • Zoledronic acid
  • Breast Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases
  • Neoplasms

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