Breast CancerPhase 2NCT00399802

A Study to Examine the Effects of an Experimental Drug on Women With Breast Cancer and Metastatic Bone Disease (MBD)(0822-016)(COMPLETED)

A Phase 2 study testing ZA and Odanacatib in people with Breast Cancer and Metastatic Bone Disease, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer, Metastatic Bone Disease
What is being tested?: ZA and Odanacatib
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 43 participants
Where: No sites listed yet
Study dates: 16 Nov 2006to 5 Dec 2007
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient has histologically or cytologically-confirmed breast cancer
Patient has documented skeletal metastases

Who cannot join

Patient is undergoing current oral bisphosphonate therapy, or has a history of oral bisphosphonate use within 6 months of entry into study

About this study

Official title: A Phase II Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Cathepsin-K Inhibitor) in the Treatment of Women With Breast Cancer and Established Bone Metastases (MBD)

This is a 4-week study to examine the effects of a new experimental medication on women with breast cancer and established bone metastases. This study will enroll approximately 45 women. The primary hypotheses are: (1) odanacatib will result in a substantial suppression of urinary N-telopeptide of type I collagen (u-NTx) similar to that achieved with an intravenous (IV) infusion of zoledronic acid (ZA) over 4 weeks of treatment; and (2) odanacatib (MK-0822) will be safe and well tolerated during 4 weeks of treatment.

Conditions: Breast Cancer, Metastatic Bone Disease
Being tested: ZA, Odanacatib, Odanacatib matching placebo, ZA matching placebo
Medical subject headings: Breast Neoplasms, Bone Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZADrug
Also called Zometa®
Single ZA 4 mg IV infusion at the start of treatment
OdanacatibDrug
Also called MK-0822
Once-daily odanacatib 5 mg tablet for 4 weeks
Odanacatib matching placeboDrug
Once-daily odanacatib matching placebo for 4 weeks
ZA matching placeboDrug
Single IV infusion of ZA matching placebo given at the start of treatment

Study groups in NCT00399802
Study group	Role	What they receive
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. Receives: Drug: ZA; Drug: Odanacatib matching placebo
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. Receives: Drug: Odanacatib; Drug: ZA matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen (u-NTx) at Week 4
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.
Measured: Baseline and Week 4
Number of Participants Who Experienced an Adverse Event (AE)
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.
Measured: Up to 6 weeks
Number of Participants Who Discontinued Treatment Due to an AE
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.
Measured: Up to 4 weeks

Secondary outcomes (1)

Percentage Change From Baseline in Urinary Deoxypyridinoline (u-DPD) at Week 4
u-DPD is a biochemical marker of bone resorption. Participants provided urine specimens on Day 1 (baseline) and Week 4 for measurement of u-DPD.
Measured: Baseline and Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Nov 20065 Dec 2007

First posted15 Nov 2006 (estimated)
Study start16 Nov 2006
Primary completion5 Dec 2007
Study completion5 Dec 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00399802
Sponsor's protocol ID: 0822-016
Other IDs: 2006_533, MK-0822-016
Status last verified: Jul 2018
First submitted: 14 Nov 2006
Last updated: 16 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Jensen AB, Wynne C, Ramirez G, He W, Song Y, Berd Y, Wang H, Mehta A, Lombardi A. The cathepsin K inhibitor odanacatib suppresses bone resorption in women with breast cancer and established bone metastases: results of a 4-week, double-blind, randomized, controlled trial. Clin Breast Cancer. 2010 Dec 1;10(6):452-8. doi: 10.3816/CBC.2010.n.059.
PubMed 21147688

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Cathepsin-K Inhibitor) in the Treatment of Women With Breast Cancer and Established Bone Metastases (MBD)
ClinicalTrials.gov ID: NCT00399802
Acronym / sponsor ID: 0822-016
Conditions: Breast Cancer, Metastatic Bone Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 16 Nov 2006 (actual)
Primary completion: 5 Dec 2007 (actual)
Study completion: 5 Dec 2007 (actual)
First posted: 15 Nov 2006 (estimated)
Results: Posted 1 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Single IV infusion of ZA 4 mg	Active comparator	Drug: ZA, Drug: Odanacatib matching placeboParticipants 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	Drug: Odanacatib, Drug: ZA matching placeboParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patient has histologically or cytologically-confirmed breast cancer
Patient has documented skeletal metastases

Key exclusion criteria (1 listed)

Patient is undergoing current oral bisphosphonate therapy, or has a history of oral bisphosphonate use within 6 months of entry into study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ZAAlso: Zometa®Single ZA 4 mg IV infusion at the start of treatment	Drug	Single IV infusion of ZA 4 mg
OdanacatibAlso: MK-0822Once-daily odanacatib 5 mg tablet for 4 weeks	Drug	Odanacatib 5 mg
Odanacatib matching placeboOnce-daily odanacatib matching placebo for 4 weeks	Drug	Single IV infusion of ZA 4 mg
ZA matching placeboSingle IV infusion of ZA matching placebo given at the start of treatment	Drug	Odanacatib 5 mg

Primary outcome

Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen (u-NTx) at Week 4
Time frame: Baseline and Week 4
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.
Number of Participants Who Experienced an Adverse Event (AE)
Time frame: Up to 6 weeks
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.
Number of Participants Who Discontinued Treatment Due to an AE
Time frame: Up to 4 weeks
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.

1 secondary outcome

Percentage Change From Baseline in Urinary Deoxypyridinoline (u-DPD) at Week 4
Time frame: Baseline and Week 4

Results and safety

Results posted to the registry on 1 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Intravenous (IV) Infusion of Zoledronic Acid (ZA) 4 mg	14	14
Once-daily Odanacatib 5 mg	29	26

Primary outcome: Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen (u-NTx) at Week 4

Time frame: Baseline and Week 4. Mean (95% Confidence Interval). Unit: Percentage change

Measure	Single IV Infusion of ZA 4 mg n = 14	Once-daily Odanacatib 5 mg n = 27
Value	-73 (-80 to -62)	-77 (-82 to -71)

Population analysed: All randomized participants who took at least one dose of study drug and had available u-NTx data for Baseline and Week 4

Primary outcome: Number of Participants Who Experienced an Adverse Event (AE)

Time frame: Up to 6 weeks. Count of participants. Unit: Participants

Measure	Single IV Infusion of ZA 4 mg n = 14	Once-daily Odanacatib 5 mg n = 29
Value	10	20

Population analysed: All randomized participants who took at least one dose of study drug

Primary outcome: Number of Participants Who Discontinued Treatment Due to an AE

Time frame: Up to 4 weeks. Count of participants. Unit: Participants

Measure	Single IV Infusion of ZA 4 mg n = 14	Once-daily Odanacatib 5 mg n = 29
Value	0	2

Population analysed: All randomized participants who took at least one dose of study drug

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 6 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single IV Infusion of ZA 4 mg	2 of 14 (14.3%)	10 of 14 (71.4%)	Not reported
Once-daily Odanacatib 5 mg	4 of 29 (13.8%)	17 of 29 (58.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21147688Jensen AB, Wynne C, Ramirez G, He W, Song Y, Berd Y, Wang H, Mehta A, Lombardi A. The cathepsin K inhibitor odanacatib suppresses bone resorption in women with breast cancer and established bone metastases: results of a 4-week, double-blind, randomized, controlled trial. Clin Breast Cancer. 2010 Dec 1;10(6):452-8. doi: 10.3816/CBC.2010.n.059.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ZA and Odanacatib in people with Breast Cancer and Metastatic Bone Disease, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen (u-NTx) at Week 4 (time frame: Baseline and Week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00399802, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.