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

Bone Metastases in Subjects With Advanced Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00104650
• Other study ID #: 20040114
• Status: Completed
• Phase: Phase 2
• First received: March 3, 2005
• Last updated: January 20, 2011
• Start date: January 2005
• Est. completion date: March 2010

Study information

• Verified date: January 2011
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaEuropean Union: European Medicines AgencyFrance: Ministry of HealthMexico: Ministry of HealthPoland: Drug InstitutUnited States: Food and Drug AdministrationUnited States: Western Institutional Review BoardBelgium: Pharmaceutical Inspectorate
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00121342

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: March 2010
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Marrow Diseases
• 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
• Bone Neoplasms
• Breast Neoplasms
• Multiple Myeloma
• Neoplasm Metastasis
• Neoplasms
• Prostatic Neoplasms

Intervention

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.

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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (2)

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 — View 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 C — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13	Urinary N-telopeptide (uNTx) corrected by creatinine (uNTx/Cr) < 50 nmol/mmol at week 13.	13 weeks	No
Secondary	uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 25	Urinary N-telopeptide (uNTX) corrected by creatinine < 50 nmol/mmol at week 25.	25 weeks	No
Secondary	Percent Change of uNTx (Corrected by Creatinne) From Baseline to 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	No
Secondary	Time to Reduction of uNTX (Corrected by Creatinine) to <50nmol/mmol	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	No
Secondary	Duration of Maintaining uNTX (Corrected by Creatinine) < 50nmol/mmol	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	No
Secondary	Percent Change of Serum CTX From Baseline to 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	No
Secondary	Time to First Skeletal Related Event	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	No
Secondary	Skeletal Related Events	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	No
Secondary	Hypercalcemia	Occurrence of hypercalcemia at grade 3 or 4 according to CTCAE v3 criteria	Day 1, week 25	Yes

External Links

•   AmgenTrials clinical trials website