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

Phase 2

Completed

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

• Registration Number: NCT00104650
• Lead Sponsor: Amgen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-03-03
• Study First Submitted QC: 2005-03-03
• Study First Posted: 2005-03-04
• Primary Completion: 2008-01
• Disposition First Submitted: 2009-11-19
• Disposition First Submitted QC: 2009-11-19
• Disposition First Posted: 2009-11-23
• Study Completion: 2010-03
• Results First Submitted: 2010-12-09
• Results First Submitted QC: 2010-12-09
• Status Verified: 2011-01
• Results First Posted: 2011-01-07
• Last Update Submitted: 2011-01-20
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV Bisphosphonates q 4 weeks	IV Bisphosphonate q 4 weeks	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.
180 mg AMG 162 (SC) q 12 weeks	AMG 162 180 mg (SC) q 12 weeks	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.
180 mg AMG 162 (SC) q 4 weeks	AMG 162- 180 mg q 4 weeks	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.

Primary Outcome Measures

Name	Time	Method
uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13	13 weeks	Urinary N-telopeptide (uNTx) corrected by creatinine (uNTx/Cr) \< 50 nmol/mmol at week 13.

Secondary Outcome Measures

Name	Time	Method
uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 25	25 weeks	Urinary N-telopeptide (uNTX) corrected by creatinine \< 50 nmol/mmol at week 25.
Percent Change of uNTx (Corrected by Creatinne) From Baseline to Week 25	Baseline, week 25	Percent change from baseline to week 25 urinary N-telopeptide (uNTX) calculated using ((week 25 value - baseline value) / baseline value ) x 100.
Time to Reduction of uNTX (Corrected by Creatinine) to <50nmol/mmol	Day 1, week 25	Kaplan-Meier estimate of the median time from enrollment to the 1st occurrence of uNTx below 50 nmol BCE/mmol (corrected by creatinine) up to week 25. For participants whose uNTx does not go below 50 nM BCE/mM creatinine, the time is censored at time of last evaluation of uNTx by week 25.
Duration of Maintaining uNTX (Corrected by Creatinine) < 50nmol/mmol	Day 1, week 25	Time from the 1st occurrence of uNTx below 50 nmol BCE/mmol (corrected by creatinine) to the 1st occurrence of uNTx above 50 nmol BCE/mmol up to week 25. For participants who remained below 50 nmol BCE/mmol, the time is censored at the time of last evaluation of uNTx up to week 25.
Percent Change of Serum CTX From Baseline to Week 25	Baseline, week 25	Percent change from baseline to week 25 in Type I serum C-Telopeptide (CTX), calculated using ((week 25 value - baseline value) / baseline value ) x 100.
Time to First Skeletal Related Event	Day 1, week 25	Time from study day 1 to first Skeletal Related Event (SRE), defined as \>1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).
Skeletal Related Events	Day 1, week 25	Skeletal Related Event (SRE), defined as \>1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).
Hypercalcemia	Day 1, week 25	Occurrence of hypercalcemia at grade 3 or 4 according to CTCAE v3 criteria