AMG 162 in Bisphosphonate Naive Metastatic Breast Cancer
This study has been completed.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00091832
First received: September 17, 2004
Last updated: December 9, 2010
Last verified: December 2010
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Purpose
This study is to evaluate various doses and schedules for AMG 162 administration and characterize the safety profile in this indication.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Metastases Bone Metastases in Subjects With Advanced Breast Cancer |
Biological: AMG 162 Drug: IV Bisphosphonates |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | A Randomized Active-controlled Study of AMG 162 in Breast Cancer Subjects With Bone Metastasis Who Have Not Previously Been Treated With Bisphosphonate Therapy. |
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:
- Percent Change From Baseline to Week 13 in uNTx/Cr [ Time Frame: Baseline and week 13 ] [ Designated as safety issue: No ]Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Percent change from baseline to week 13 calculated using ((week 13 value - baseline value) / baseline value ) x 100.
Secondary Outcome Measures:
- Percent Change From Baseline to Week 25 in uNTx [ Time Frame: Baseline and week 25 ] [ Designated as safety issue: No ]Urinary N-telopeptide (uNTx). Percent change from baseline to week 25 calculated using ((week 25 value - baseline value) / baseline value ) x 100.
- Achieving 65% or More Reduction in uNTx From Baseline at Week 13 [ Time Frame: Baseline and week 13 ] [ Designated as safety issue: No ]Achieving a 65% reduction or more in uNTx from baseline at week 13. Calculation used is ((week 13 value - baseline value) / baseline value ) x 100 and subjects considered having 65% reduction or more if their value is <=-65%.
- Achieving 65% or More Reduction in uNTX From Baseline at Week 25 [ Time Frame: Baseline and week 25 ] [ Designated as safety issue: No ]Achieving a 65% reduction or more in uNTX from baseline at week 25. Calculation used is ((week 25 value - baseline value) / baseline value ) x 100 and subjects considered having 65% reduction or more if their value is <=-65%.
- Time to 65% or More Reduction in uNTX From Baseline [ Time Frame: Baseline and week 57 ] [ Designated as safety issue: No ]Kaplan-Meier estimate of the median time from enrollment to the 1st occurrence of a reduction of uNTx of ≥ 65% compared to baseline. For subjects whose uNTx does not go below 65% of the baseline value, the time is censored at time of last evaluation of uNTx.
- Percent Change From Baseline to Week 13 in Serum CTX [ Time Frame: Baseline and week 13 ] [ Designated as safety issue: No ]Type I serum C-Telopeptide (CTX). Percent change from baseline to week 13 calculated using ((week 13 value - baseline value) / baseline value ) x 100.
- Percent Change From Baseline to Week 25 in Serum CTX [ Time Frame: Baseline and week 25 ] [ Designated as safety issue: No ]Type I serum C-Telopeptide (CTX). Percent change from baseline to week 25 calculated using ((week 25 value - baseline value) / baseline value ) x 100.
- Percent Change From Baseline to Week 13 in P1NP [ Time Frame: Baseline and week 13 ] [ Designated as safety issue: No ]Procollagen 1 N-terminal peptide (P1NP). Percent change from baseline to week 13 calculated using ((week 13 value - baseline value) / baseline value ) x 100.
- Percent Change From Baseline to Week 25 in P1NP [ Time Frame: Baseline and week 25 ] [ Designated as safety issue: No ]Procollagen 1 N-terminal peptide (P1NP). Percent change from baseline to week 25 calculated using ((week 25 value - baseline value) / baseline value ) x 100.
- Percent Change From Baseline to Week 13 in TRAP5b [ Time Frame: Baseline and week 13 ] [ Designated as safety issue: No ]Tartrate-resistant acid phosphatase 5b (TRAP5b). Percent change from baseline to week 13 calculated using ((week 13 value - baseline value) / baseline value ) x 100.
- Percent Change From Baseline to Week 25 in TRAP5b [ Time Frame: Baseline and week 25 ] [ Designated as safety issue: No ]Tartrate-resistant acid phosphatase 5b (TRAP5b). Percent change from baseline to week 25 calculated using ((week 25 value - baseline value) / baseline value ) x 100.
- Percent Change From Baseline to Week 13 in BSAP [ Time Frame: Baseline and week 13 ] [ Designated as safety issue: No ]Bone specific alkaline phosphatase (BSAP). Percent change from baseline to week 13 calculated using ((week 13 value - baseline value) / baseline value ) x 100.
- Percent Change From Baseline to Week 25 in BSAP [ Time Frame: Baseline and week 25 ] [ Designated as safety issue: No ]Bone specific alkaline phosphatase (BSAP). Percent change from baseline to week 25 calculated using ((week 25 value - baseline value) / baseline value ) x 100.
- Percent Change From Baseline to Week 13 in Osteocalcin [ Time Frame: Baseline and week 13 ] [ Designated as safety issue: No ]Percent change from baseline to week 13 calculated using ((week 13 value - baseline value) / baseline value ) x 100.
- Percent Change From Baseline to Week 25 in Osteocalcin [ Time Frame: Baseline and week 25 ] [ Designated as safety issue: No ]Percent change from baseline to week 25 calculated using ((week 25 value - baseline value) / baseline value ) x 100.
- Time to First Skeletal Related Event [ Time Frame: Day 1 and 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).
- Skeletal Related Event [ Time Frame: Day 1 and 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).
- Occurrence of Hypercalcemia [ Time Frame: Day 1 and week 57 ] [ Designated as safety issue: Yes ]Occurrence of hypercalcemia at grade 3 or 4 according to Common Terminology Criteria for Adverse Events (CTCAE) v3. A summary of hypercalcemia events is reported under adverse event.
| Enrollment: | 255 |
| Study Start Date: | September 2004 |
| Study Completion Date: | October 2006 |
| Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 60 mg AMG 162, q12 weeks
60 mg AMG 162, q12 weeks
|
Biological: AMG 162
Subjects will be stratified by anti-neoplastic treatment (hormonal therapy vs. chemotherapy, if both are used treatment will be classified as chemotherapy) at the study entry and randomized to 1 of 6 treatment arms (n=40/cohort). The AMG 162 cohorts will be blinded to the dose and schedule. The bisphosphonate arm will be open-label.
|
|
Experimental: 120 mg AMG 162 SC, q4 weeks
120 mg AMG 162 SC, q4 weeks
|
Biological: AMG 162
Subjects will be stratified by anti-neoplastic treatment (hormonal therapy vs. chemotherapy, if both are used treatment will be classified as chemotherapy) at the study entry and randomized to 1 of 6 treatment arms (n=40/cohort). The AMG 162 cohorts will be blinded to the dose and schedule. The bisphosphonate arm will be open-label.
|
|
Experimental: 180 mg AMG 162 SC, q4 weeks
180 mg of AMG 162 given SC, q4 weeks
|
Biological: AMG 162
Subjects will be stratified by anti-neoplastic treatment (hormonal therapy vs. chemotherapy, if both are used treatment will be classified as chemotherapy) at the study entry and randomized to 1 of 6 treatment arms (n=40/cohort). The AMG 162 cohorts will be blinded to the dose and schedule. The bisphosphonate arm will be open-label.
|
|
Active Comparator: IV bisphosphonates, q4 weeks
IV bisphosphonates, q4 weeks (active comparator)
|
Drug: IV Bisphosphonates
Approximately 40 subjects were enrolled in the open label bisphosphonate arm (administered per package insert).
|
|
Experimental: 180 mg AMG 162 SC, q12 weeks
180 mg AMG 162 SC, q12 weeks
|
Biological: AMG 162
Subjects will be stratified by anti-neoplastic treatment (hormonal therapy vs. chemotherapy, if both are used treatment will be classified as chemotherapy) at the study entry and randomized to 1 of 6 treatment arms (n=40/cohort). The AMG 162 cohorts will be blinded to the dose and schedule. The bisphosphonate arm will be open-label.
|
|
Experimental: 30 mg AMG 162 SC. q4 weeks
dose of 30 mg AMG 162 given SC q4 weeks
|
Biological: AMG 162
Subjects will be stratified by anti-neoplastic treatment (hormonal therapy vs. chemotherapy, if both are used treatment will be classified as chemotherapy) at the study entry and randomized to 1 of 6 treatment arms (n=40/cohort). The AMG 162 cohorts will be blinded to the dose and schedule. The bisphosphonate arm will be open-label.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria: - Confirmation of breast cancer - At least one bone metastasis
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00091832 History of Changes |
| Other Study ID Numbers: | 20040113 |
| Study First Received: | September 17, 2004 |
| Results First Received: | December 9, 2010 |
| Last Updated: | December 9, 2010 |
| Health Authority: | Australia: Human Research Ethics Committee Australia: Therapeutic Goods Administration Austria: AGES - PharmaMed Austria Institut Wissenschaft & Information Austria: Bundesamt fur Sicherheit im Gesundheitswesen Austria: Bundesamt für Sicherheit im Gesundheitswesen Austria: Central Ethics Committee Austria: Competant Authority Austria: Secretariat of Health Belgium: Directorate general for the protection of Public health: Medicines Belgium: Directorate-General for Medicinal Products Belgium: Federal Public Service (FPS) Health, Food Chain Safety and Environment Belgium: FPS of Public Health, Food Chain Security and Environment Belgium: Pharmaceutical Inspectorate Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Health Canada Canada: Health Products and Food Branch Canada: Institutional Review Board European Union: European Medicines Agency France and Sweden: European Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: CCPPRB Central Ethics Committee France: Ministry of Health Germany: Federal Institute for Drugs and Medical Devices Italy: Local Ethics Committees Italy: Ministry of Health Mexico: COFEPRIS Mexico: Ministry of Health Belgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et Environnement Belgium: Service Public Fédéral Santé Publique, Sécurité de la Chaîne alimentaire et Environnement Mexico: SSA (Secretaria de Salud Publica) Portugal: National Institute of Pharmacy and Medicines Spain: Agencia Española de Medicamentos y Productos Sanitarios Spain: Spanish Agency of Medicines Spain: Spanish Drug Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Amgen:
|
Breast Cancer Cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasm Metastasis Neoplasms, Second Primary Bone Neoplasms Bone Marrow Diseases Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Neoplastic Processes Pathologic Processes Bone Diseases Musculoskeletal Diseases Hematologic Diseases Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013