Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates

Amgen

Status and phase: Completed; Phase 2

Conditions: Bone Metastases in Subjects With Advanced Breast Cancer; Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma; Bone Metastases in Men With Hormone-Refractory Prostate Cancer

Treatments: Genetic: AMG 162 180 mg (SC) q 12 weeks; Drug: IV Bisphosphonate q 4 weeks; Genetic: AMG 162- 180 mg q 4 weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT00104650

20040114

Details and patient eligibility

About

The purpose of this trial is to determine the effectiveness of AMG 162 in reducing urinary N-telopeptide in advanced cancer subjects with bone metastases.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 3 patient groups

IV Bisphosphonates q 4 weeks

Active Comparator group

Description:

This is an open-label randomization to receive IV bisphosphonate (administered per package insert) every 4 weeks during the treatment phase. If subjects are enrolled into the extension phase, they will receive AMG 162 180mg (SC) every 4 weeks.

Treatment:

Drug: IV Bisphosphonate q 4 weeks

180 mg AMG 162 (SC) q 12 weeks

Experimental group

Description:

This is an open-label randomization to receive 180 mg AMG 162 (SC) every 12 weeks during the treatment phase. If subjects are enrolled into the extension phase, they will continue to receive 180 mg AMG 162 (SC) every 12 weeks.

Treatment:

Genetic: AMG 162 180 mg (SC) q 12 weeks

180 mg AMG 162 (SC) q 4 weeks

Experimental group

Description:

This is an open-label randomization to receive 180 mg AMG 162 (SC) every 4 weeks during the treatment phase. If subject is enrolled into the extension phase, they will continue to receive 180 mg AMG 162 (SC) every 4 weeks.

Treatment:

Genetic: AMG 162- 180 mg q 4 weeks