A Study of ENMD-2076 in Ovarian Clear Cell Cancers



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:6/23/2016
Start Date:September 2013
End Date:January 2018
Contact:Amit Oza, M.D.
Phone:416-946-288

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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.

During the study, participants will be asked to take ENMD-2076 once a day, everyday. Every
28 days will be called a cycle. While receiving the study drug, participants will be asked
to visit the clinic for tests and procedures. During Cycle 1, participants will be asked to
visit the clinic about once a week and during Cycle 2 and future cycles, participants will
be asked to visit the clinic on days 1 and 15. As a part of the study, tumor tissue
(archival and fresh tumor biopsy) will be taken for biomarker research. When participants
stop the study drug, they will be asked to have an end of study drug visit.

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
We found this trial at
2
sites
Philadelphia, Pennsylvania 19111
Principal Investigator: Lainie Martin, M.D.
Phone: 215-728-3889
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Philadelphia, PA
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Calgary, Alberta
Principal Investigator: Prafull Ghatage
Phone: 403-521-3721
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Calgary,
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