Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates
This study has been completed.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00104650
First received: March 3, 2005
Last updated: January 20, 2011
Last verified: January 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Genetic: AMG 162 180 mg (SC) q 12 weeks Drug: IV Bisphosphonate q 4 weeks Genetic: AMG 162- 180 mg q 4 weeks |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Open Label, Active Controlled Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous Bisphosphonates |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Denosumab
U.S. FDA Resources
Further study details as provided by Amgen:
Primary Outcome Measures:
- uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13 [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]Urinary N-telopeptide (uNTx) corrected by creatinine (uNTx/Cr) < 50 nmol/mmol at week 13.
Secondary Outcome Measures:
- uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 25 [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, week 25 ] [ Designated as safety issue: No ]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 [ Time Frame: Day 1, week 25 ] [ Designated as safety issue: No ]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 [ Time Frame: Day 1, week 25 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, week 25 ] [ Designated as safety issue: No ]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 [ Time Frame: Day 1, week 25 ] [ Designated as safety issue: No ]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 [ Time Frame: Day 1, week 25 ] [ Designated as safety issue: No ]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 [ Time Frame: Day 1, week 25 ] [ Designated as safety issue: Yes ]Occurrence of hypercalcemia at grade 3 or 4 according to CTCAE v3 criteria
| Enrollment: | 111 |
| Study Start Date: | January 2005 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00104650 History of Changes |
| Obsolete Identifiers: | NCT00121342 |
| Other Study ID Numbers: | 20040114 |
| Study First Received: | March 3, 2005 |
| Results First Received: | December 9, 2010 |
| Last Updated: | January 20, 2011 |
| Health Authority: | Canada: Health Canada European Union: European Medicines Agency France: Ministry of Health Mexico: Ministry of Health Poland: Drug Institut United States: Food and Drug Administration United States: Western Institutional Review Board Belgium: Pharmaceutical Inspectorate |
Keywords provided by Amgen:
|
Bone Metastases AMG 162 Bisphosphonates Solid Tumor Carcinomas Advanced |
Additional relevant MeSH terms:
|
Breast Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Neoplasm Metastasis Neoplasms, Second Primary Prostatic Neoplasms Bone Neoplasms Bone Marrow Diseases Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Neoplasms by Histologic Type Hemostatic Disorders Vascular Diseases |
Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Neoplastic Processes Pathologic Processes Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Diseases Bone Diseases |
ClinicalTrials.gov processed this record on May 19, 2013