Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00399802 | A Study to Examine the Effects of an Experimental Drug on Women With Breast Cancer and Metastatic Bone Disease (MBD)(0822-016)(COMPLETED) | PHASE2 | COMPLETED | 43 | — | — | Nov 16, 2006 | Dec 5, 2007 | Aug 16, 2018 | - | — |
u-NTx is a biochemical index of bone resorption. Participants provided urine specimens on Day 1 (baseline) and at Week 4 for measurement of u-NTx.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
| Arm | Type | Description |
|---|---|---|
| Single IV infusion of ZA 4 mg | ACTIVE_COMPARATOR | Participants will receive a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks. |
| Odanacatib 5 mg | EXPERIMENTAL | Participants will receive a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment. |
| Name | Type | Description |
|---|---|---|
| ZA | DRUG | Single ZA 4 mg IV infusion at the start of treatment |
| Odanacatib | DRUG | Once-daily odanacatib 5 mg tablet for 4 weeks |
| Odanacatib matching placebo | DRUG | Once-daily odanacatib matching placebo for 4 weeks |
| ZA matching placebo | DRUG | Single IV infusion of ZA matching placebo given at the start of treatment |
Inclusion Criteria: * Patient has histologically or cytologically-confirmed breast cancer * Patient has documented skeletal metastases Exclusion Criteria: * Patient is undergoing current oral bisphosphonate therapy, or has a history of oral bisphosphonate use within 6 months of entry into study