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A Randomized, Open Label, Active Controlled Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous Bisphosphonates


Phase 2
18 Years
N/A
Not 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

A Randomized, Open Label, Active Controlled Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous Bisphosphonates


Inclusion Criteria:



- Patients at least 18 years of age with histologically confirmed solid tumor
carcinomas (except lung) or multiple myeloma

- Radiographic evidence of 1 or more bone lesions or lytic lesion in myeloma

- Currently receiving IV bisphosphonates

- Urinary N-Telopeptide (uNTx) greater than 50 nM BCE/mM creatinine

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

Exclusion Criteria:

- More than 2 prior skeletal related events (SRE)

- Known brain metastases

- Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw

- Active dental or jaw conditions which requires oral surgery

- Non-healed dental/oral surgery

- Prior administration of AMG 162

- Evidence of impending fracture in weight bearing bones

- Pregnancy or breastfeeding. Subjects must be surgically sterile, postmenopausal, or
must agree to use effective contraception during the study.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13

Outcome Description:

Urinary N-telopeptide (uNTx) corrected by creatinine (uNTx/Cr) < 50 nmol/mmol at week 13.

Outcome Time Frame:

13 weeks

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Canada: Health Canada

Study ID:

20040114

NCT ID:

NCT00104650

Start Date:

January 2005

Completion Date:

March 2010

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
  • AMG 162
  • Bisphosphonates
  • Solid Tumor Carcinomas
  • Advanced
  • Breast Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases
  • Neoplasms

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