Skip to main content
OpenTrials
Completed

NCT Number: NCT00104650

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bone Metastases in Men With Hormone-Refractory Prostate Cancer Blood Protein Disorders Bone Metastases in Subjects With Advanced Breast Cancer Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AMG 162 180 mg (SC) q 12 weeks

Genetic

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.

IV Bisphosphonate q 4 weeks

Drug

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.

AMG 162- 180 mg q 4 weeks

Genetic

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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).

  8. Hypercalcemia

    Time frame: Day 1, week 25

    Occurrence of hypercalcemia at grade 3 or 4 according to CTCAE v3 criteria

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2010
First posted
Mar 4, 2005
Registry last updated
Jan 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.