Ovarian CancerPhase 2NCT01104675
Study of Oral ENMD-2076 Administered to Patients With Ovarian Cancer
A Phase 2 study testing ENMD-2076 in people with Ovarian Cancer and Fallopian Cancer, run by CASI pharmaceuticals, Inc. at 6 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether oral ENMD-2076 is effective in treatment of patients with platinum resistant ovarian, fallopian, or peritoneal cancer. Additional sites to be added. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Cancer, Peritoneal Cancer
- What is being tested?
- ENMD-2076
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Apr 2010to 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
- Have histologically documented diagnosis of ovarian, fallopian or peritoneal cancer that is platinum resistant.
- Have a pre-study echocardiogram or multigated acquisition (MUGA) scan with an actual left ventricular ejection fraction of greater than or equal to the institution lower limit of normal
- Greater than or equal to 18 years of age
- Have clinically acceptable laboratory screening results
- Have an ECOG performance status of 0 or 1
- Able to tolerate oral medications
Who cannot join
- Have uncontrolled hypertension (systolic blood pressure greater than 150mmHg or diastolic blood pressure greater than 100mmHg); require two or more antihypertensive medications to control hypertension (including ACE inhibitors, beta blockers, calcium channel blockers, or diuretics)
- Have chronic atrial fibrillation or QTc interval corrected for heart rate of greater than 470 msec
- Have active, acute, or chronic clinically significant infections or bleeding
- Have persistent 2+ protein by urinalysis or a history of nephrotic syndrome
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
University of Colorado Cancer Center
Aurora, Colorado, 80045
Dana Farber/Partners Cancer Care
Boston, Massachusetts, 02115
University of Chicago Medical Center
Chicago, Illinois, 60637
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
Memorial Sloan-Kettering Cancer Center
New York, New York
About this study
Official title: A Phase 2 Study of Oral ENMD-2076 Administered to Patients With Platinum Resistant Ovarian Cancer
The purpose of this study is to determine whether oral ENMD-2076 is effective in treatment of patients with platinum resistant ovarian, fallopian, or peritoneal cancer. Additional sites to be added.
- Conditions
- Ovarian Cancer, Fallopian Cancer, Peritoneal Cancer
- Being tested
- ENMD-2076
- Keywords
- ovarian, platinum resistant ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENMD-2076Drug
275 mg (or 250 mg for BSA < 1.65) per day in oral capsules in 28 day continuous cycles
| Study group | Role | What they receive |
|---|---|---|
| ENMD-2076 treatment | Experimental | Not described Receives: Drug: ENMD-2076 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian 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
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- CASI pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Gannon, MD, MBA, Study director, CASI pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104675
- Sponsor's protocol ID
- 2076-CL-004
- Status last verified
- Aug 2014
- First submitted
- 14 Apr 2010
- Last updated
- 6 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Oral ENMD-2076 Administered to Patients With Platinum Resistant Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01104675
- Acronym / sponsor ID
- 2076-CL-004
- Conditions
- Ovarian Cancer, Fallopian Cancer, Peritoneal Cancer
- Keywords
- ovarian, platinum resistant ovarian cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- CASI pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Apr 2010 (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.
The purpose of this study is to determine whether oral ENMD-2076 is effective in treatment of patients with platinum resistant ovarian, fallopian, or peritoneal cancer. Additional sites to be added.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ENMD-2076 treatment | Experimental | Drug: ENMD-2076 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have histologically documented diagnosis of ovarian, fallopian or peritoneal cancer that is platinum resistant.
- Have a pre-study echocardiogram or multigated acquisition (MUGA) scan with an actual left ventricular ejection fraction of greater than or equal to the institution lower limit of normal
- Greater than or equal to 18 years of age
- Have clinically acceptable laboratory screening results
- Have an ECOG performance status of 0 or 1
Key exclusion criteria (4 listed)
- Have uncontrolled hypertension (systolic blood pressure greater than 150mmHg or diastolic blood pressure greater than 100mmHg); require two or more antihypertensive medications to control hypertension (including ACE inhibitors, beta blockers, calcium channel blockers, or diuretics)
- Have chronic atrial fibrillation or QTc interval corrected for heart rate of greater than 470 msec
- Have active, acute, or chronic clinically significant infections or bleeding
- Have persistent 2+ protein by urinalysis or a history of nephrotic syndrome
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 |
|---|---|---|
| ENMD-2076275 mg (or 250 mg for BSA < 1.65) per day in oral capsules in 28 day continuous cycles | Drug | ENMD-2076 treatment |
Primary outcome
Progression free survival rate
Time frame: 6 months
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 6 Aug 2014.
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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.
William Gannon, MD, MBA study director
CASI pharmaceuticals, Inc.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ENMD-2076 in people with Ovarian Cancer and Fallopian Cancer, run by CASI pharmaceuticals, Inc. at 6 sites in 2 countries.
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 6 inclusion and 4 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 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. 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 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?
Progression free survival rate (time frame: 6 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 6 Aug 2014.