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Also known as Zometa®
ZA · 1 trial · 2 indications
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
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ZA is an investigational small molecule being studied for the treatment of breast cancer, specifically in women with breast cancer and metastatic bone disease. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
ZA is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with breast cancer and metastatic bone disease.
ZA is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, active-controlled study. The drug remains investigational and has not been approved for any use.
ZA has been studied in one completed Phase 2 clinical trial, identified as NCT00399802. This trial examined the effects of ZA in women with breast cancer and metastatic bone disease, enrolling 43 participants. The study was randomized, double-blind, and active-controlled.
No, ZA is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for breast cancer with metastatic bone disease. The completed Phase 2 trial, NCT00399802, has finished, but the drug has not yet received regulatory approval.