A Study of ENMD-2076 in Ovarian Clear Cell Cancers

NCT01914510 | Completed Phase 2 Results DMC

• 1 other identifier: ENMD-2076-OCC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Ovarian Clear Cell Carcinoma

Keywords

ovarian; cancer; clear cell; ENMD-2076; oral; capsule

Outcome Measures

Primary Outcomes (2)

• Six Month Progression Free Survival Rate

  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.

  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.

• Complete or Partial Response Rate

  Percentage of patients with complete or partial response as per RECIST 1.1 criteria.

  2 years

Secondary Outcomes (2)

• Time to Disease Progression

  2 years

• Levels of Certain Proteins and Gene Expression Compared to Patient Outcome Following Treatment

  2 years

Study Arms (1)

ENMD-2076

EXPERIMENTAL

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.

Drug: ENMD-2076

Interventions

ENMD-2076 DRUG

ENMD-2076

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (6)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Cancer Agency

Vancouver, Alberta, V5Z 4E6, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Neoplasms

Interventions

ENMD 2076

Results Point of Contact

• Title: Dr. Amit Oza
• Organization: University Health Network - Princess Margaret Cancer Centre

amit.oza@uhn.ca

416-946-2818

Study Officials

• Amit Oza, M.D.

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: August 2, 2013
• Study Start: September 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: December 13, 2019
• Results First Posted: December 13, 2019

Record last verified: 2019-12

Locations

CA (6)