Clinical trial NCT00104650: Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates
Official title: A Randomized, Open Label, Active Controlled Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous Bisphosphonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Keywords: Bone Metastases
AMG 162
Bisphosphonates
Solid Tumor Carcinomas
Advanced
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-03-04
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13
timeFrame: 13 weeks
Secondary outcomes:
measure: uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 25
timeFrame: 25 weeks
measure: Percent Change of uNTx (Corrected by Creatinne) From Baseline to Week 25
timeFrame: Baseline, week 25
measure: Time to Reduction of uNTX (Corrected by Creatinine) to <50nmol/mmol
timeFrame: Day 1, week 25
measure: Duration of Maintaining uNTX (Corrected by Creatinine) < 50nmol/mmol
timeFrame: Day 1, week 25
measure: Percent Change of Serum CTX From Baseline to Week 25
timeFrame: Baseline, week 25
measure: Time to First Skeletal Related Event
timeFrame: Day 1, week 25
measure: Skeletal Related Events
timeFrame: Day 1, week 25
measure: Hypercalcemia
timeFrame: Day 1, week 25
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Fizazi K, Lipton A, Mariette X, Body JJ, Rahim Y, Gralow JR, Gao G, Wu L, Sohn W, Jun S. Randomized phase II trial of denosumab in patients with bone metastases from prostate cancer, breast cancer, or other neoplasms after intravenous bisphosphonates. J Clin Oncol. 2009 Apr 1;27(10):1564-71. doi: 10.1200/JCO.2008.19.2146. Epub 2009 Feb 23.
citation: Fizazi K, Bosserman L, Gao G, Skacel T, Markus R. Denosumab treatment of prostate cancer with bone metastases and increased urine N-telopeptide levels after therapy with intravenous bisphosphonates: results of a randomized phase II trial. J Urol. 2009 Aug;182(2):509-15; discussion 515-6. doi: 10.1016/j.juro.2009.04.023. Epub 2009 Jun 13.
citation: Jakob T, Tesfamariam YM, Macherey S, Kuhr K, Adams A, Monsef I, Heidenreich A, Skoetz N. Bisphosphonates or RANK-ligand-inhibitors for men with prostate cancer and bone metastases: a network meta-analysis. Cochrane Database Syst Rev. 2020 Dec 3;12(12):CD013020. doi: 10.1002/14651858.CD013020.pub2.
citation: Fizazi K, Bosserman L, Gao G, Skacel T, Markus R. Denosumab treatment of prostate cancer with bone metastases and increased urine N-telopeptide levels after therapy with intravenous bisphosphonates: results of a randomized phase II trial. J Urol. 2013 Jan;189(1 Suppl):S51-7; discussion S57-8. doi: 10.1016/j.juro.2012.11.022.