AdvancedPhase 2NCT01719744
Study of ENMD-2076 in Patients With Advanced/Metastatic Soft Tissue Sarcoma
A Phase 2 study testing ENMD-2076 in people with Advanced and Metastatic, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a phase 2 study of ENMD-2076 in patients with advanced/metastatic soft tissue sarcoma. This study will help to understand how well ENMD-2076 works and how safe and tolerable the drug is in this patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced, Metastatic, Soft Tissue Sarcoma
- 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
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Jan 2016
- 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
- Have documented histological diagnosis of soft tissue sarcoma (e.g. leiomyosarcoma, synovial sarcoma, angiosarcoma and liposarcoma etc), with the exception of gastrointestinal stromal tumor (GIST).
- Meet revised RECIST criteria (version 1.1) within 4 weeks of entry by having measurable disease defined as one or more lesions that can be accurately measured in one or more dimensions. Areas of previous radiation may not serve as measurable disease unless there has been objective interval tumor growth documented radiologically.
- Must have had no more than 1 line of treatment in the advanced/metastatic setting. The use of prior anti-angiogenic therapy is allowed. Previous neo-adjuvant or adjuvant therapies are allowed.
- Are at least 3 weeks from major surgery or radiation therapy and recovered; 3 weeks from any other previous anticancer therapy and recovered including biologics.
- Are ≥ 18 years of age
- The patient has a multigated acquisition (MUGA) scan with an actual left ventricular ejection fraction of greater than or equal to the institution lower limit of normal within one month prior to start of study.
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- Have clinically acceptable laboratory screening results within certain limits specified below:
- AST and ALT ≤ 2.5 times upper limit of normal (ULN) or less than or equal to 5 times ULN if liver metastases are present
- Total bilirubin ≤ 1.5 x ULN
- Creatinine ≤ 1.5 x ULN or > 50 ml/min calculated by the Cockcroft and Gault formula (formula defined in appendix E).
- Absolute neutrophil count ≥ 1500 cells/mm3
- Platelets ≥ 100,000/mm3
- Hemoglobin ≥ 9.0 g/dL
- INR ≤ 1.5
- Have an ECOG performance status of 0 or 1.
- Patients must have and consent for access to archival material (for correlative studies). Patients who do not have archival material will be eligible if they consent for fresh tissue biopsy.
- Women of child producing potential must agree to use effective contraceptive methods prior to study entry, during study participation, and for at least 30 days after the last administration of study medication. A serum pregnancy test within 72 hours prior to the initiation of therapy will be required for women of childbearing potential.
- Have the ability to understand the requirements of the study, provide written informed consent which includes authorization for release of protected health information, abide by the study restrictions, and agree to return for the required assessments.
- Able to tolerate oral medications.
Who cannot join
- Women who are pregnant or nursing
- Have active, acute, or chronic clinically significant infections or bleeding.
- Have uncontrolled hypertension (systolic blood pressure greater than 150mmHg or diastolic blood pressure greater than 100mmHg); or history of congestive heart failure (equal to or greater than Grade 2 classification by New York Heath Association).
- Have active angina pectoris, stroke or recent myocardial infarction (within 6 months).
- Have chronic atrial fibrillation or QTc interval corrected for heart rate of greater than 480 msec.
- Have additional uncontrolled serious medical or psychiatric illness.
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- Require therapeutic doses of anti-coagulation either by virtue of low-molecular weight heparin or coumadin (prophylactic anti-coagulation allowed). Patients with previous history of deep venous thrombosis or pulmonary embolism are also excluded.
- Known CNS metastases
- Have any medical condition that would impair the administration of oral agents including recurrent bowel obstructions, inflammatory bowel disease or uncontrolled nausea, vomiting or diarrhea
- Have 2+ protein by urinalysis. Patients with an ongoing or previous history of nephrotic syndrome will be excluded
- Have an additional malignancy diagnosed within 5 years of study enrollment with the exception of basal or squamous cell skin cancer or cervical cancer in situ
- Require treatment with drugs known to be potent inducers or inhibitors of CYP3A4 that cannot be substituted
- Patients who cannot or refuse to stop herbal medications of illicit drug use will be excluded from the study. Use of medical marijuana is not permissible in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Oral ENMD-2076 Administered to Patients With Advanced/Metastatic Soft Tissue Sarcoma
This is a phase 2 study of ENMD-2076 in patients with advanced/metastatic soft tissue sarcoma. This study will help to understand how well ENMD-2076 works and how safe and tolerable the drug is in this patient population.
Read the detailed description
ENMD-2076 is an oral drug that works by blocking certain enzymes called Aurora A from working. These enzymes are needed for cells to divide including cancer cells. ENMD-2076 also works by stopping the growth of new blood vessels which would provide the tumor with nutrients for it to grow. It is believed that by blocking Aurora A enzymes from working and stopping new blood vessels from growing, the tumors may stop growing or shrink.
- Conditions
- Advanced, Metastatic, Soft Tissue Sarcoma
- Being tested
- ENMD-2076
- Keywords
- ENMD-2076, advanced, metastatic, soft tissue sarcoma
- Medical subject headings
- Neoplasm Metastasis, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENMD-2076Drug
| Study group | Role | What they receive |
|---|---|---|
| ENMD-2076 | Experimental | ENMD-2076 capsules, 275 mg once daily, by mouth. Receives: Drug: ENMD-2076 |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month Progression-free Survival Rate (PFS)
Number of patients with no progression of disease at 6 months
Measured: From start of study treatment until disease progression or death, whichever occurs first, up to 6 months.
Secondary outcomes (2)
Number of and Severity of Adverse Events Per Participant
Number of participants who experienced a grade 3 or higher adverse event. Reporting threshold 5%
Measured: 2 years
Objective Response Rate
Objective Response Rate (ORR) = CR+ PR. ORR is evaluated per RECIST v1.1 criteria.
Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
Measured: From start of study treatment until disease progression or death, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2015
- Study completionJan 2016
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 AdvancedStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Albiruni Razak, MBBS, Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719744
- Sponsor's protocol ID
- 2076-STS-001
- Status last verified
- Jul 2023
- First submitted
- 30 Oct 2012
- Last updated
- 1 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Oral ENMD-2076 Administered to Patients With Advanced/Metastatic Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT01719744
- Acronym / sponsor ID
- 2076-STS-001
- Conditions
- Advanced, Metastatic, Soft Tissue Sarcoma
- Keywords
- ENMD-2076, advanced, metastatic, soft tissue sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 1 Nov 2012 (estimated)
- Results
- Posted 7 Nov 2017
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 study of ENMD-2076 in patients with advanced/metastatic soft tissue sarcoma. This study will help to understand how well ENMD-2076 works and how safe and tolerable the drug is in this patient population.
Detailed description
ENMD-2076 is an oral drug that works by blocking certain enzymes called Aurora A from working. These enzymes are needed for cells to divide including cancer cells. ENMD-2076 also works by stopping the growth of new blood vessels which would provide the tumor with nutrients for it to grow. It is believed that by blocking Aurora A enzymes from working and stopping new blood vessels from growing, the tumors may stop growing or shrink.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ENMD-2076 | Experimental | Drug: ENMD-2076ENMD-2076 capsules, 275 mg once daily, by mouth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Have documented histological diagnosis of soft tissue sarcoma (e.g. leiomyosarcoma, synovial sarcoma, angiosarcoma and liposarcoma etc), with the exception of gastrointestinal stromal tumor (GIST).
- Meet revised RECIST criteria (version 1.1) within 4 weeks of entry by having measurable disease defined as one or more lesions that can be accurately measured in one or more dimensions. Areas of previous radiation may not serve as measurable disease unless there has been objective interval tumor growth documented radiologically.
- Must have had no more than 1 line of treatment in the advanced/metastatic setting. The use of prior anti-angiogenic therapy is allowed. Previous neo-adjuvant or adjuvant therapies are allowed.
- Are at least 3 weeks from major surgery or radiation therapy and recovered; 3 weeks from any other previous anticancer therapy and recovered including biologics.
- Are ≥ 18 years of age
Key exclusion criteria (13 listed)
- Women who are pregnant or nursing
- Have active, acute, or chronic clinically significant infections or bleeding.
- Have uncontrolled hypertension (systolic blood pressure greater than 150mmHg or diastolic blood pressure greater than 100mmHg); or history of congestive heart failure (equal to or greater than Grade 2 classification by New York Heath Association).
- Have active angina pectoris, stroke or recent myocardial infarction (within 6 months).
- Have chronic atrial fibrillation or QTc interval corrected for heart rate of greater than 480 msec.
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-2076 | Drug | ENMD-2076 |
Primary outcome
6-month Progression-free Survival Rate (PFS)
Time frame: From start of study treatment until disease progression or death, whichever occurs first, up to 6 months.
Number of patients with no progression of disease at 6 months
2 secondary outcomes
Number of and Severity of Adverse Events Per Participant
Time frame: 2 years
Objective Response Rate
Time frame: From start of study treatment until disease progression or death, whichever occurs first.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- 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.
Albiruni Razak, MBBS principal investigator
Princess Margaret Cancer Centre
1 site in 1 country: 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 Advanced and Metastatic, run by University Health Network, Toronto at 1 site in Canada.
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 19 inclusion and 13 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 1 Aug 2023. 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 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?
Yes. Results are posted in the registry (first posted 7 Nov 2017). 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?
6-month Progression-free Survival Rate (PFS) (time frame: From start of study treatment until disease progression or death, whichever occurs first, up to 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 1 Aug 2023.