Metastatic Breast CancerPhase 2PEG-SN38NCT01036113
A Phase 2 Study of EZN-2208 in Patients With Metastatic Breast Cancer
A Phase 2 study testing EZN-2208 in people with Metastatic Breast Cancer, run by Enzon Pharmaceuticals, Inc. at 36 sites in United States.
Trial summary
This is a Phase 2, multicenter, open-label, noncomparative study to evaluate safety,efficacy and of single-agent EZN 2208 administered in patients with previously treated MBC. After discontinuation of study treatment, patients will receive care as considered appropriate by the investigator. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- EZN-2208
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 36 sitesUnited States
- Study dates
- Nov 2009to Dec 2012
- Phase
- Phase 2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed breast adenocarcinoma that is metastatic. Receptor status of the tumor must be known.
- Disease progression during or after immediate previous therapy, or intolerable toxicity leading to cessation of immediate previous therapy
- Previous treatment for MBC:
- AT Cohort: Prior AT required as adjuvant or metastatic therapy; no more than 2 prior chemotherapy regimens for MBC.
- ATX Cohort: Prior ATX required as adjuvant or metastatic therapy;no more than 4 prior chemotherapy regimens for MBC.
- For patients with positive receptor status:
Show all 12Show fewer
- Patients with HER2+ MBC must have received prior trastuzumab.
- Patients with ER+ MBC must have received prior hormone therapy.
- Measurable disease by RECIST Version 1.1
- Women 18 years or older
- ECOG performance status of 0 to 2
- Adequate bone marrow, renal and hepatic functions
Who cannot join
- Major surgery within 3 weeks before study start
- Known or suspected brain metastases requiring intervention with steroids and/or radiation therapy
- Prior chemotherapy, immunotherapy, non-investigational agent, or other therapy used to treat the cancer within 3 weeks before scheduled administration of EZN-2208
- History of other primary cancer within 5 years of enrollment, unless
- Curatively resected non-melanomatous skin cancer, or
- Curatively resected cervical cancer
Show all 9Show fewer
- Lack of recovery to Grade 1 from any reversible side effects related to the administration of an investigational agent, chemotherapy, or other prior treatments for the cancer
- Current participation in another clinical study with an investigational agent and/or use of an investigational drug (not including investigational use of an approved drug) in the 30 days before the first administration of EZN-2208
- Known chronic infectious disease, such as AIDS
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Location #33
Abilene, Texas, 79606
Location #34
Arlington, Texas, 76014
Location #9
Austin, Texas, 78705
Location #3
Bedford, Texas, 76022
Location #15
Carmel, Indiana, 46032
Location #16
Columbia, Missouri, 65201
Location #41
Columbus, Ohio, 43219
Location #26
Dallas, Texas, 75230-2510
Location #13
Dallas, Texas, 75231
Location #30
Dallas, Texas, 75237
Location #17
Dallas, Texas, 75246
Location #18
Denver, Colorado, 80220
Location #23
Fairfax, Virginia, 22031
Location #24
Fort Worth, Texas, 76104
Location #8
Greenville, South Carolina, 29605
Location #2
Henderson, Nevada, 89074
Location #11
Houston, Texas, 77024
Location #14
Kansas City, Missouri, 64131
Location #38
Lewisville, Texas, 75067
Location #31
McAllen, Texas, 78503
Location # 28
Midland, Texas, 79701
Location #10
Minneapolis, Minnesota, 55404
Location #32
Murrieta, California, 92562
Location #36
New Port Richey, Florida, 34655
Location #40
Niles, Illinois, 60714
Location #7
Norfolk, Virginia, 23502
Location #1
Ocoee, Florida, 34761
Location #39
Oxnard, California, 93030
Location #27
Portland, Oregon, 97213-2996
Location #4
Raleigh, North Carolina, 27607
Location #21
Salem, Virginia, 24153
Location #12
Sedona, Arizona, 86336
Location #35
Sugar Land, Texas, 77479
Location#19
Troy, New York, 12180
Location #5
Tucson, Arizona, 85704
Location# 20
Tyler, Texas, 75702
About this study
Official title: A Phase 2, Open-Label Study of EZN-2208 (PEG-SN38) in Patients With Previously Treated Metastatic Breast Cancer (MBC)
This is a Phase 2, multicenter, open-label, noncomparative study to evaluate safety,efficacy and of single-agent EZN 2208 administered in patients with previously treated MBC.
After discontinuation of study treatment, patients will receive care as considered appropriate by the investigator. Patients will continue to be followed for disease progression, subsequent anticancer therapy, and survival.
Read the detailed description
EZN-2208 will be administered by i.v. infusion weekly for 3 weeks in 4-week cycles. Study treatment will be continued until evidence of disease progression, unacceptable toxicity, or withdrawal of the patient's consent for participation in the study.
Approximately 160 patients with previously treated MBC will be enrolled in this study. Eighty patients in each of two cohorts will be evaluated as follows:
- AT Cohort - Patients treated with prior anthracycline and taxane as adjuvant or metastatic therapy; no more than 2 prior chemotherapy regimens for MBC
- ATX Cohort - Patients treated with prior anthracycline, taxane, and Xeloda® (capecitabine) as adjuvant or metastatic therapy; no more than 4 prior chemotherapy regimens for MBC
After discontinuation of study treatment, patients will receive care as considered appropriate by the investigator. Patients will continue to be followed for disease progression, subsequent anticancer therapy, and survival for at least 6 months after enrollment of the last patient in the study
- Conditions
- Metastatic Breast Cancer
- Being tested
- EZN-2208
- Keywords
- EZN-2208 (PEG-SN38)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EZN-2208Drug
Also called Peg SN38
EZN-2208 will be administered as an i.v. infusion on weekly basis for 3 weeks and repeated every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: EZN-2208 | Experimental | Experimental: EZN-2208 EZN-2208 will be administered as an i.v. infusion on weekly basis for 3 weeks and repeated every 28 days. Receives: Drug: EZN-2208 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Measured: 2011
Secondary outcomes (1)
Progression Free Survival (PFS)
Measured: 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionFeb 2012
- Study completionDec 2012
Why it stopped: Program suspended and divested
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Enzon Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joyce A O'Shaughnessy, MD, Principal investigator, Texas Oncology-Baylor Charles A. Sarnrnons Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01036113
- Sponsor's protocol ID
- EZN-2208-03
- Acronym
- PEG-SN38
- Status last verified
- Oct 2012
- First submitted
- 17 Dec 2009
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label Study of EZN-2208 (PEG-SN38) in Patients With Previously Treated Metastatic Breast Cancer (MBC)
- ClinicalTrials.gov ID
- NCT01036113
- Acronym / sponsor ID
- PEG-SN38 / EZN-2208-03
- Conditions
- Metastatic Breast Cancer
- Keywords
- EZN-2208 (PEG-SN38)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Program suspended and divested
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Enzon Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Dec 2009 (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.
This is a Phase 2, multicenter, open-label, noncomparative study to evaluate safety,efficacy and of single-agent EZN 2208 administered in patients with previously treated MBC.
After discontinuation of study treatment, patients will receive care as considered appropriate by the investigator. Patients will continue to be followed for disease progression, subsequent anticancer therapy, and survival.
Detailed description
EZN-2208 will be administered by i.v. infusion weekly for 3 weeks in 4-week cycles. Study treatment will be continued until evidence of disease progression, unacceptable toxicity, or withdrawal of the patient's consent for participation in the study.
Approximately 160 patients with previously treated MBC will be enrolled in this study. Eighty patients in each of two cohorts will be evaluated as follows:
- AT Cohort - Patients treated with prior anthracycline and taxane as adjuvant or metastatic therapy; no more than 2 prior chemotherapy regimens for MBC
- ATX Cohort - Patients treated with prior anthracycline, taxane, and Xeloda® (capecitabine) as adjuvant or metastatic therapy; no more than 4 prior chemotherapy regimens for MBC
After discontinuation of study treatment, patients will receive care as considered appropriate by the investigator. Patients will continue to be followed for disease progression, subsequent anticancer therapy, and survival for at least 6 months after enrollment of the last patient in the study
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: EZN-2208 | Experimental | Drug: EZN-2208Experimental: EZN-2208 EZN-2208 will be administered as an i.v. infusion on weekly basis for 3 weeks and repeated every 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed breast adenocarcinoma that is metastatic. Receptor status of the tumor must be known.
- Disease progression during or after immediate previous therapy, or intolerable toxicity leading to cessation of immediate previous therapy
- Previous treatment for MBC:
- For patients with positive receptor status:
- Measurable disease by RECIST Version 1.1
Key exclusion criteria (9 listed)
- Major surgery within 3 weeks before study start
- Known or suspected brain metastases requiring intervention with steroids and/or radiation therapy
- Prior chemotherapy, immunotherapy, non-investigational agent, or other therapy used to treat the cancer within 3 weeks before scheduled administration of EZN-2208
- History of other primary cancer within 5 years of enrollment, unless
- Lack of recovery to Grade 1 from any reversible side effects related to the administration of an investigational agent, chemotherapy, or other prior treatments for the cancer
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 |
|---|---|---|
| EZN-2208Also: Peg SN38EZN-2208 will be administered as an i.v. infusion on weekly basis for 3 weeks and repeated every 28 days. | Drug | Experimental: EZN-2208 |
Primary outcome
Response Rate
Time frame: 2011
1 secondary outcome
Progression Free Survival (PFS)
Time frame: 2011
Results and safety
The study was stopped early (reason given: Program suspended and divested). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
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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.
Joyce A O'Shaughnessy, MD principal investigator
Texas Oncology-Baylor Charles A. Sarnrnons Cancer Center
36 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 EZN-2208 in people with Metastatic Breast Cancer, run by Enzon Pharmaceuticals, Inc. at 36 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 12 inclusion and 9 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: stopped early, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 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?
The study was stopped early (reason given: Program suspended and divested). Results are not available in the source record.
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?
Response Rate (time frame: 2011). 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 14 Feb 2022.