Breast CancerPhase 2NCT00992225
A Study of LY573636-sodium in Patients With Metastatic Breast Cancer
A Phase 2 study testing LY573636-sodium in people with Breast Cancer, run by Eli Lilly and Company at 5 sites in United States.
Trial summary
The primary purpose of this study is to determine the objective response rate (complete and partial response) for patients who receive LY573636-sodium for metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- LY573636-sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2009to Apr 2011
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Received at least 2 or more prior chemotherapy regimens for metastatic breast cancer.
- Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 4 weeks. Patients who have received whole-brain radiation must wait 90 days.
Who cannot join
- Serious pre-existing medical condition.
- Have active central nervous system or leptomeningeal metastasis.
- Current hematologic malignancies, acute or chronic leukemia.
- Receiving Warfarin (Coumadin).
- Have a history of radiation therapy involving more than 25% of the bone marrow.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
For additional information regarding investigative sites for this trial, contact 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 speak with your personal physician.
Indianapolis, Indiana, 46202
For additional information regarding investigative sites for this trial, contact 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 speak with your personal physician.
Memphis, Tennessee, 38138
For additional information regarding investigative sites for this trial, contact 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 speak with your personal physician.
Portland, Oregon, 97225
For additional information regarding investigative sites for this trial, contact 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 speak with your personal physician.
Tampa, Florida, 33612
For additional information regarding investigative sites for this trial, contact 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 speak with your personal physician.
Temple, Texas, 76508
About this study
Official title: Phase 2 Evaluation of a Once Every 28 Days Dosing Regimen for LY573636-sodium in Patients With Metastatic Breast Cancer
The primary purpose of this study is to determine the objective response rate (complete and partial response) for patients who receive LY573636-sodium for metastatic breast cancer.
Read the detailed description
Patient will receive a 2-hour intravenous infusion of study drug (LY573636-sodium) once every 28 days. Radiologic imaging scans will be performed before the first dose of study drug and then after every other treatment. Patients will be assessed for clinical progression at every visit and for response approximately every 56 days (every other cycle).
- Conditions
- Breast Cancer
- Being tested
- LY573636-sodium
- Keywords
- Metastatic
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY573636-sodiumDrug
Also called tasisulam
Dose is adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation are met
| Study group | Role | What they receive |
|---|---|---|
| LY573636-sodium | Experimental | Not described Receives: Drug: LY573636-sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With an Objective Overall Response
Objective overall response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. It is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
Measured: Baseline to measured progressive disease or death from any cause up to 12 months
Secondary outcomes (6)
Progression-free Survival
Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using RECIST criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
Measured: Baseline to measured progressive disease or death from any cause up to 12 months
Percentage of Participants Experiencing Clinical Benefit [(CR) + (PR) + Stable Disease (SD)]
Clinical Benefit Rate = [(CR) + (PR) + Stable Disease (SD)] of at least 4 cycles/N as classified by the investigator according to the RECIST guidelines, where N = total number of participants with at least one dose of study drug. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Measured: Baseline to measured progressive disease or death from any cause up to 12 months
Duration of Overall Response
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to RECIST guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions.
Measured: Time of response to progressive disease or death up to 12 months
Duration of Stable Disease
Duration of stable disease (SD) is defined from date of documented SD to first date of progressive disease (PD) or death from any cause (assessed every other cycle during study therapy, or every 2 months during post-therapy). SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
Measured: Time from documented Stable Disease (SD) to first date of progressive disease or death from any cause up to 12 months
The Percentage of Participants With Exposures in the Target Range
Exposure is the amount of drug the body sees in a period of time. Target range is an exposure thought to offer the optimal balance of safety and efficacy based on prior research.
Measured: After drug infusion in cycles 1 and 2 (5 samples drawn over each 28 day cycle)
Maximum Concentration (Cmax)
Measured: After drug infusion in cycles 1 and 2 (5 samples drawn over each 28 day cycle)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2011
- Study completionApr 2011
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992225
- Sponsor's protocol ID
- 12265
- Other IDs
- H8K-MC-JZAL
- Status last verified
- Jun 2018
- First submitted
- 7 Oct 2009
- Last updated
- 17 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Evaluation of a Once Every 28 Days Dosing Regimen for LY573636-sodium in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00992225
- Acronym / sponsor ID
- 12265
- Conditions
- Breast Cancer
- Keywords
- Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 9 Oct 2009 (estimated)
- Results
- Posted 17 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to determine the objective response rate (complete and partial response) for patients who receive LY573636-sodium for metastatic breast cancer.
Detailed description
Patient will receive a 2-hour intravenous infusion of study drug (LY573636-sodium) once every 28 days. Radiologic imaging scans will be performed before the first dose of study drug and then after every other treatment. Patients will be assessed for clinical progression at every visit and for response approximately every 56 days (every other cycle).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LY573636-sodium | Experimental | Drug: LY573636-sodium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Received at least 2 or more prior chemotherapy regimens for metastatic breast cancer.
- Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 4 weeks. Patients who have received whole-brain radiation must wait 90 days.
Key exclusion criteria (5 listed)
- Serious pre-existing medical condition.
- Have active central nervous system or leptomeningeal metastasis.
- Current hematologic malignancies, acute or chronic leukemia.
- Receiving Warfarin (Coumadin).
- Have a history of radiation therapy involving more than 25% of the bone marrow.
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 |
|---|---|---|
| LY573636-sodiumAlso: tasisulamDose is adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation are met | Drug | LY573636-sodium |
Primary outcome
Percentage of Participants With an Objective Overall Response
Time frame: Baseline to measured progressive disease or death from any cause up to 12 months
Objective overall response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. It is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
6 secondary outcomes
Progression-free Survival
Time frame: Baseline to measured progressive disease or death from any cause up to 12 months
Percentage of Participants Experiencing Clinical Benefit [(CR) + (PR) + Stable Disease (SD)]
Time frame: Baseline to measured progressive disease or death from any cause up to 12 months
Duration of Overall Response
Time frame: Time of response to progressive disease or death up to 12 months
Duration of Stable Disease
Time frame: Time from documented Stable Disease (SD) to first date of progressive disease or death from any cause up to 12 months
The Percentage of Participants With Exposures in the Target Range
Time frame: After drug infusion in cycles 1 and 2 (5 samples drawn over each 28 day cycle)
Maximum Concentration (Cmax)
Time frame: After drug infusion in cycles 1 and 2 (5 samples drawn over each 28 day cycle)]
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY573636-sodium in people with Breast Cancer, run by Eli Lilly and Company at 5 sites 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 2 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 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 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 17 Jul 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 of Participants With an Objective Overall Response (time frame: Baseline to measured progressive disease or death from any cause up to 12 months). 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 17 Jul 2018.