- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01914510
A Study of ENMD-2076 in Ovarian Clear Cell Cancers
Phase II Study of Oral ENMD-2076 Administered to Patients With Ovarian Clear Cell Carcinomas
This is a phase 2 study to see how useful, safe, and tolerable an investigational drug called ENMD-2076 is in treating patients with ovarian clear cell carcinomas.
ENMD-2076 is an oral drug that works by blocking certain enzymes called Aurora A and tyrosine kinase 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 and tyrosine kinase enzymes from working and stopping new blood vessels from growing, the tumors may stop growing or shrink.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Centre
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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Vancouver, Alberta, Canada, V5Z 4E6
- British Columbia Cancer Agency
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Ontario
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London, Ontario, Canada, N6A 4L6
- London Regional Cancer Program
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Ottawa, Ontario, Canada, K1H 8L6
- Ottawa Regional Cancer Centre
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Cancer Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Have histologically documented diagnosis of ovarian clear cell carcinoma.
- Any number of prior chemotherapy regimens will be allowed but must include 1 line of platinum based therapy, and may include chemotherapy, biologics or other targeted therapies (except for Aurora A targeted therapies).
- Meet RECIST criteria (version 1.1) within 28 days of start of treatment 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 is evidence of progression post radiation.
- At time of registration, if the patient has had previous treatment it must have been at least 4 weeks since major surgery or radiation therapy; four weeks from any other previous anti-cancer therapy including biologics. Patients must have recovered from their treatment-related events with the exception of alopecia.
- Are ≥18 years of age
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 UL
- Absolute neutrophil count ≥ 1500 cells/mm
- Platelets ≥ 150,000/mm3
- Hemoglobin ≥ 9.0 g/dl
- Have an ECOG performance status of ≤ 2
- 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, abide by the study restrictions, and agree to return for the required assessments.
- Able to tolerate oral medication.
Exclusion Criteria:
- 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).
- Have active angina pectoris, stroke, previous myocardial infarction within the past 12 months and not clinically stable, or any other pre-existing uncontrolled cardiovascular condition.
- Have chronic atrial fibrillation or QTc interval corrected for heart rate of greater than 470 msec.
- Have additional uncontrolled serious medical or psychiatric illness.
- Require therapeutic doses of anti-coagulation with warfarin or other coumarin derivatives. However, treatment with low molecular weight heparin (LMWH) is allowed.
- 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 persistent 2+ protein by urinalysis (patients with 2+ proteinuria that have a spot protein:creatinine ratio of less than 0.3 may be enrolled) or a history of nephrotic syndrome
- Have an active or history of additional malignancy which in the opinion of the study doctor would make assessment of outcome difficult.
- Require treatment with drugs known to be potent inducers or inhibitors of CYP3A4 at the time of registration
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ENMD-2076
ENMD-2067 will be taken orally at a dose of 275 mg, once a day, everyday.
Patients with a body surface area of less than 1.65 m2 will receive a starting dose of 250 mg, once a day, everyday.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Six Month Progression Free Survival Rate
Time Frame: Response will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1. Progression free survival is the time from the first day of treatment to the first observation of disease progression or Death/last F/U.
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Progression Free Survival (PFS) is defined as the time from first day of treatment to the first observation of disease progression or death due to any cause or last follow up.
PFS will be censored for patients who are alive and free of progression at time of last follow-up.
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Response will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1. Progression free survival is the time from the first day of treatment to the first observation of disease progression or Death/last F/U.
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Complete or Partial Response Rate
Time Frame: 2 years
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Percentage of patients with complete or partial response as per RECIST 1.1 criteria.
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Disease Progression
Time Frame: 2 years
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Length of time until disease progression in patients treated with ENMD-2076
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2 years
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Levels of Certain Proteins and Gene Expression Compared to Patient Outcome Following Treatment
Time Frame: 2 years
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Association of somatic mutations in PIK3CA, ARID1A and PTEN mutation status, and ARID1A and PTEN expression assessed in archival samples and tumour biopsies with tumour response and patient outcome following treatment with ENMD 2076.
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2 years
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ENMD-2076-OCC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Clear Cell Carcinoma
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M.D. Anderson Cancer CenterGSK Pharma; LixteRecruitingOvarian Clear Cell CarcinomaUnited States
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Nuvectis Pharma, Inc.GOG Foundation; European Network of Gynaecological Oncological Trial Groups...RecruitingOvarian Cancer | Ovarian Endometrioid Adenocarcinoma | Advanced Solid Tumor | Ovarian Clear Cell Carcinoma | Ovarian Clear Cell Adenocarcinoma | Ovarian Clear Cell Tumor | Ovarian Endometrioid Tumor | ARID1A Gene MutationUnited States, United Kingdom
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Peking University Third HospitalNot yet recruitingOvarian Clear Cell Carcinoma
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National University Hospital, SingaporeUnknownOvarian Clear Cell CarcinomaSingapore
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Tongji HospitalWuhan University; Henan Cancer Hospital; Qilu Hospital of Shandong University; Hubei... and other collaboratorsRecruitingOvarian Clear Cell CarcinomaChina
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NHS Greater Glasgow and ClydeBoehringer Ingelheim; Cancer Research UK; European Organisation for Research... and other collaboratorsUnknownOvarian Clear Cell Carcinoma | Endometrial Clear Cell CarcinomaUnited Kingdom
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National Cancer Institute (NCI)NRG OncologyCompletedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Ovarian Clear Cell Adenocarcinoma | Fallopian Tube Clear Cell AdenocarcinomaUnited States
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National Cancer Institute (NCI)NRG OncologyCompletedRecurrent Ovarian Carcinoma | Ovarian Clear Cell AdenocarcinomaUnited States, Korea, Republic of
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National Cancer Institute (NCI)AstraZeneca; NRG OncologyActive, not recruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Ovarian Seromucinous Carcinoma | Ovarian Undifferentiated Carcinoma | Ovarian Clear Cell Adenocarcinoma | Fallopian Tube Transitional Cell Carcinoma | Ovarian Transitional Cell Carcinoma | Fallopian... and other conditionsUnited States, Canada, Korea, Republic of, Japan
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M.D. Anderson Cancer CenterActive, not recruitingRecurrent Platinum-Resistant Ovarian Carcinoma | Recurrent Fallopian Tube Clear Cell Adenocarcinoma | Recurrent Ovarian Clear Cell Adenocarcinoma | Recurrent Platinum-Resistant Fallopian Tube Carcinoma | Recurrent Platinum-Resistant Primary Peritoneal Carcinoma | Recurrent Primary Peritoneal...United States
Clinical Trials on ENMD-2076
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University Health Network, TorontoCompletedSoft Tissue Sarcoma | Metastatic | AdvancedCanada
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CASI Pharmaceuticals, Inc.University of Colorado, Denver; Indiana University Melvin and Bren Simon Cancer...CompletedTriple Negative Breast CancerUnited States, China
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CASI Pharmaceuticals, Inc.Completed
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CASI Pharmaceuticals, Inc.CompletedAdvanced Adult Hepatocellular Carcinoma | Advanced Fibrolamellar CarcinomaUnited States
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CASI Pharmaceuticals, Inc.CompletedOvarian Cancer | Peritoneal Cancer | Fallopian CancerUnited States, Canada
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CASI Pharmaceuticals, Inc.CompletedRelapsed or Refractory Hematological MalignanciesCanada
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CASI Pharmaceuticals, Inc.CompletedAdvanced CancerUnited States