NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer



Status:Recruiting
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/19/2019
Start Date:September 28, 2017
End Date:June 2020
Contact:Ruth Coy
Email:Ruth.Coy@chiltern.com
Phone:+44 7397009645

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A Phase II Open-Label Study of NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer

This study will evaluate the effect of two dose levels of NUC-1031 (500 mg/m2 and 750mg/m2)
in patients with ovarian cancer. The primary objective is to determine the anti-tumor
activity of NUC-1031 at the selected dose level (500 mg/m2 or 750 mg/m2).

Up to 20 patients will be treated at each dose in Part I of the study. In Part II of the
study, one of the treatment dose levels will be selected for further evaluation. The dose
selection will be based on clinical and laboratory assessments of patients recruited in Part
I. Patients will only participate in either Part I or II. A total of 64 patients will be
treated in Part I and Part II combined.

Eligible consenting patients will receive NUC-1031 by IV infusion on days 1, 8 and 15 of each
28-day cycle. Patients will continue to receive NUC-1031 until the occurrence of disease
progression. Patients will undergo imaging every 8 weeks. After disease progression, patients
will be followed for overall survival.

Inclusion Criteria:

1. Provision of signed written informed consent.

2. Original diagnosis and/or histological confirmation of high-grade serous, high-grade
endometrioid, undifferentiated/unclassifiable epithelial ovarian, fallopian tube or
primary peritoneal cancer.

3. Time from the last line of platinum-based chemotherapy of less than 6 months.

4. Received at least 3 prior chemotherapy-containing regimens.

5. Age ≥18 years.

6. Ability to comply with protocol requirements.

7. Patients are not of childbearing potential or they must agree to use a physical method
of contraception.

Exclusion Criteria:

1. Disease that progressed while receiving initial line of platinum-based chemotherapy.

2. Received fewer than 3 prior chemotherapy-containing regimens.

3. Prior therapy with single-agent gemcitabine.

4. Prior history of hypersensitivity to gemcitabine.

5. Prior chemotherapy, radiation (other than short cycle of radiation to reduce bone
pain), treatment with a VEGF inhibitor, PARP inhibitor or immunotherapy within 21 days
of first receipt of study drug. Hormone therapy within 14 days of first receipt of
study drug.

6. Residual side effects from chemotherapy or radiation, which have not gotten better
except for nerve pain or tingling or hair loss.

7. Patients who have a history of another type of cancer diagnosed within the past 5
years, with the exception of adequately treated non-melanoma skin cancer curatively
treated cervical cancer or ductal carcinoma in situ (DCIS) of the breast.

8. Presence of an serious illness, uncontrolled illness, or active infection requiring IV
antibiotics.

9. Presence of any serious illnesses, serious medical conditions, serious medical
history, active bacterial or viral infections including hepatitis B or C, or known to
be HIV positive.

10. Currently pregnant, lactating or breastfeeding.

11. History of blocked intestines because of ovarian cancer, unless fully resolved.
We found this trial at
16
sites
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: John Moroney, MD
University of Chicago One of the world's premier academic and research institutions, the University of...
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Austin, Texas 78745
Principal Investigator: Michael G Teneriello, MD
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Edina, Minnesota 55435
Principal Investigator: Jessica A Thomes-Pepin, MD
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Edina, MN
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Edinburgh, EH4 2XR
Principal Investigator: Charley M Gourley, MB ChB
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Fort Worth, Texas 76104
Principal Investigator: Noelle G Cloven, MD
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Kansas City, Missouri 64132
Principal Investigator: Kristopher LyBarger, MD
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Lakewood, Colorado
Principal Investigator: Ling Ma, MD
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2004 Hayes Street
Nashville, Tennessee 37203
Principal Investigator: Erika Hamilton, MD
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Nashville, TN
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433 Southwest 10th Street
Ocala, Florida 34471
Principal Investigator: Samuel E Myrick, MD
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Ocala, FL
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101 The City Drive South
Orange, California 92868
Principal Investigator: Krishnansu Tewari, MD
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3030 6th Street South
Saint Petersburg, Florida 33705
Principal Investigator: Gail Wright, MD
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Saint Petersburg, FL
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Scottsdale, Arizona 85258
Principal Investigator: Heather Dalton, MD
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1221 Madison Street
Seattle, Washington 98104
Principal Investigator: Joshua Press, MD
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Tucson, Arizona 85704
Principal Investigator: Joseph Buscema, MD
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Tyler, Texas 75702
Principal Investigator: Donald A Richards, MD
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312 Clematis Street
West Palm Beach, Florida 33401
Principal Investigator: Daniel Spitz, MD
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