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

January 20, 2011 updated by: Amgen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IV Bisphosphonates 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.
Drug: IV Bisphosphonate q 4 weeks
IV Bisphosphonate (eg pamidronate or zoledronic acid) every 4 weeks for 6 doses as described by package insert during the treatment phase. If enrolled to the extension phase, subject will be assigned to the AMG 162 180mg (SC) every 4 weeks for 26 doses.
Experimental: 180 mg AMG 162 (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.
Genetic: AMG 162 180 mg (SC) q 12 weeks
A 180 mg AMG 162 (SC) administered every 12 weeks for 2 doses (Day 1 and wk 13) in the treatment phase. If subjected are enrolled in the extension phase, they will continue to receive a 180 mg AMG 162 (SC) administered every 12 weeks for 9 doses.
Experimental: 180 mg AMG 162 (SC) 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.
Genetic: AMG 162- 180 mg q 4 weeks
A 180 mg AMG 162 (SC) administered every 4 weeks for 6 doses in the treatment phase. If subjected are enrolled in the extension phase, they will continue to receive a 180 mg AMG 162 (SC) administered every 4 weeks for 26 doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13
Time Frame: 13 weeks
Urinary N-telopeptide (uNTx) corrected by creatinine (uNTx/Cr) < 50 nmol/mmol at week 13.
13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 25
Time Frame: 25 weeks
Urinary N-telopeptide (uNTX) corrected by creatinine < 50 nmol/mmol at week 25.
25 weeks
Percent Change of uNTx (Corrected by Creatinne) From Baseline to Week 25
Time Frame: 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.
Baseline, week 25
Time to Reduction of uNTX (Corrected by Creatinine) to <50nmol/mmol
Time Frame: 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.
Day 1, week 25
Duration of Maintaining uNTX (Corrected by Creatinine) < 50nmol/mmol
Time Frame: 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.
Day 1, week 25
Percent Change of Serum CTX From Baseline to Week 25
Time Frame: 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.
Baseline, week 25
Time to First Skeletal Related Event
Time Frame: 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).
Day 1, week 25
Skeletal Related Events
Time Frame: 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).
Day 1, week 25
Hypercalcemia
Time Frame: Day 1, week 25
Occurrence of hypercalcemia at grade 3 or 4 according to CTCAE v3 criteria
Day 1, week 25

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

March 3, 2005

First Submitted That Met QC Criteria

March 3, 2005

First Posted (Estimate)

March 4, 2005

Study Record Updates

Last Update Posted (Estimate)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 20, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20040114

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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