Breast CancerPhase 4NCT00190697
A Study of LY353381 (Arzoxifene) for Patients Who Benefitted From This Drug in Other Oncology Trials and Wished to Continue Treatment
A Phase 4 study testing arzoxifene in people with Breast Cancer and Endometrial Cancer, run by Eli Lilly and Company at 1 site in United States.
Trial summary
Patients who were previously enrolled on the LY353381 arm of any LY353381 oncology trial could enroll in this "roll-over" study if they had exhibited clinical benefit from treatment and wished to continue on treatment. Patients were monitored for safety. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Endometrial Cancer, Ovarian Cancer
- What is being tested?
- arzoxifene
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to Apr 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participation in a clinical trial of LY353381 that has met its main safety and efficacy objectives, and could otherwise close.
- Evidence of continuing benefit with LY353381 (eg. complete response, partial response or stable disease with no symptomatic or clinical evidence of disease progression).
- Adequate bone marrow reserve, liver and renal function, consistent with the previous LY353381 protocol, with no recent significant deterioration or metabolic condition that could affect patient safety or compliance with the protocol (eg, hypercalcemia).
- Written informed consent from patient.
- Childbearing potential either terminated by surgery, radiation, menopause, or attenuated by use of an intra-uterine contraceptive device or barrier method during and for 3 months after the trial.
Who cannot join
- No concurrent systemic therapy (immunotherapy, hormone therapy or chemotherapy) for cancer. Palliative radiotherapy is allowed (eg, for pain) as long as there is no evidence of disease progression. Investigational agents, other than LY353381, within the 4 weeks prior to this study enrollment and other SERMs are also not permitted.
- No concurrent use of oral contraceptives, GnRH agonists, or coumarin (warfarin).
- No serious concomitant systemic disorders incompatible with the study (at the discretion of investigator), including predisposition to thromboembolic disorder.
- Must not be pregnant or breast-feeding.
- Must not have a gap in treatment of more than 4 weeks between previous LY353381 study and enrollment in current study.
Trial locations and contacts
1 site in 1 country.
United States1 site
For information regarding investigative sites for this clinical trial, call 1-877- CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or contact your personal physician
Houston, Texas, 77030
About this study
Official title: Continuation of Treatment and Monitoring of Safety in Patients Treated With LY353381 for Advanced Cancer
Patients who were previously enrolled on the LY353381 arm of any LY353381 oncology trial could enroll in this "roll-over" study if they had exhibited clinical benefit from treatment and wished to continue on treatment. Patients were monitored for safety.
- Conditions
- Breast Cancer, Endometrial Cancer, Ovarian Cancer
- Being tested
- arzoxifene
- Medical subject headings
- Breast Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arzoxifeneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To allow continued treatment of patients who exhibited clinical benefit from arzoxifene
Secondary outcomes (1)
To collect long-term safety data on arzoxifene use in advanced cancer patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJan 2001
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-285-4559 (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190697
- Sponsor's protocol ID
- 5234
- Other IDs
- H4Z-MC-JWXM
- Status last verified
- May 2007
- First submitted
- 12 Sep 2005
- Last updated
- 25 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuation of Treatment and Monitoring of Safety in Patients Treated With LY353381 for Advanced Cancer
- ClinicalTrials.gov ID
- NCT00190697
- Acronym / sponsor ID
- 5234
- Conditions
- Breast Cancer, Endometrial Cancer, Ovarian Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2001
- Study completion
- Apr 2007 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients who were previously enrolled on the LY353381 arm of any LY353381 oncology trial could enroll in this "roll-over" study if they had exhibited clinical benefit from treatment and wished to continue on treatment. Patients were monitored for safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Participation in a clinical trial of LY353381 that has met its main safety and efficacy objectives, and could otherwise close.
- Evidence of continuing benefit with LY353381 (eg. complete response, partial response or stable disease with no symptomatic or clinical evidence of disease progression).
- Adequate bone marrow reserve, liver and renal function, consistent with the previous LY353381 protocol, with no recent significant deterioration or metabolic condition that could affect patient safety or compliance with the protocol (eg, hypercalcemia).
- Written informed consent from patient.
- Childbearing potential either terminated by surgery, radiation, menopause, or attenuated by use of an intra-uterine contraceptive device or barrier method during and for 3 months after the trial.
Key exclusion criteria (5 listed)
- No concurrent systemic therapy (immunotherapy, hormone therapy or chemotherapy) for cancer. Palliative radiotherapy is allowed (eg, for pain) as long as there is no evidence of disease progression. Investigational agents, other than LY353381, within the 4 weeks prior to this study enrollment and other SERMs are also not permitted.
- No concurrent use of oral contraceptives, GnRH agonists, or coumarin (warfarin).
- No serious concomitant systemic disorders incompatible with the study (at the discretion of investigator), including predisposition to thromboembolic disorder.
- Must not be pregnant or breast-feeding.
- Must not have a gap in treatment of more than 4 weeks between previous LY353381 study and enrollment in current 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 |
|---|---|---|
| arzoxifene | Drug | – |
Primary outcome
To allow continued treatment of patients who exhibited clinical benefit from arzoxifene
1 secondary outcome
To collect long-term safety data on arzoxifene use in advanced cancer patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2007.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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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.
Call 1-877-285-4559 (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing arzoxifene in people with Breast Cancer and Endometrial Cancer, run by Eli Lilly and Company at 1 site in United States.
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 5 inclusion and 5 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 25 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To allow continued treatment of patients who exhibited clinical benefit from arzoxifene. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2007.