Phase 2
Completed N=111
Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates
Bone Metastases in Men With Hormone-Refractory Prostate Cancer · Bone Metastases in Subjects With Advanced Breast Cancer · Multiple Myeloma
Source: ClinicalTrials.gov NCT00104650 ↗
Enrolled (actual)
111
Serious AEs
51.8%
Results posted
Jan 2011
Primary outcomePrimary: uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13 — 10; 21; 28 Participants — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13 |
10; 21; 28 | <0.001 sig |
| SECONDARY uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 25 |
13; 21; 23 | — |
| SECONDARY Percent Change of uNTx (Corrected by Creatinne) From Baseline to Week 25 |
-32.91; -69.09; -41.68 | 0.388 |
| SECONDARY Time to Reduction of uNTX (Corrected by Creatinine) to <50nmol/mmol |
65; 9; 10 | <0.001 sig |
| SECONDARY Duration of Maintaining uNTX (Corrected by Creatinine) < 50nmol/mmol |
25; 32; 35 | 0.006 sig |
| SECONDARY Percent Change of Serum CTX From Baseline to Week 25 |
-40.68; -76.74; -68.39 | 0.056 |
| SECONDARY Time to First Skeletal Related Event |
6; 4; 2 | 0.105 |
| SECONDARY Skeletal Related Events |
6; 4; 2 | — |
| SECONDARY Hypercalcemia |
0; 0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00104650). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.