NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer
Stopped early · Phase 2
Conditions studied: Ovarian Cancer
In brief
This study was designed to evaluate the effect of two dose levels of NUC-1031 (500 mg/m2 and 750mg/m2) in patients with ovarian cancer. The primary objective was to determine the anti-tumor activity of NUC-1031 at the selected dose level (500 mg/m2 or 750 mg/m2).
Key facts
- Study ID
- NCT03146663
- Run by
- NuCana plc
- People needed
- 53
- Starts
- 2017-09-28
- Expected to finish
- 2019-12-31
- Last updated by the study team
- 2021-02-21
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Provision of signed written informed consent.
- Original diagnosis and/or histological confirmation of high-grade serous, high-grade endometrioid, undifferentiated/unclassifiable epithelial ovarian, fallopian tube or primary peritoneal cancer.
- Time from the last line of platinum-based chemotherapy of less than 6 months.
- Received at least 3 prior chemotherapy-containing regimens.
- Age ≥18 years.
- Ability to comply with protocol requirements.
- Patients are not of childbearing potential or they must agree to use a physical method of contraception.
You may not qualify if…
- Disease that progressed while receiving initial line of platinum-based chemotherapy.
- Received fewer than 3 prior chemotherapy-containing regimens.
- Prior therapy with single-agent gemcitabine.
- Prior history of hypersensitivity to gemcitabine.
- 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.
- Residual side effects from chemotherapy or radiation, which have not gotten better except for nerve pain or tingling or hair loss.
- 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.
- Presence of an serious illness, uncontrolled illness, or active infection requiring IV antibiotics.
- 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.
- Currently pregnant, lactating or breastfeeding.
- History of blocked intestines because of ovarian cancer, unless fully resolved.
Where it is running
- Arizona Oncology Associates, PC - HAL — Phoenix, Arizona, United States
- Arizona Oncology Associates, PC - HOPE — Tucson, Arizona, United States
- Rocky Mountain Cancer Centers, LLP — Lakewood, Colorado, United States
- Florida Cancer Specialists and Research Institute — St. Petersburg, Florida, United States
- Minnesota Oncology Hematology, P.A. — Edina, Minnesota, United States
- SCRI - HCA Health Midwest — Kansas City, Missouri, United States
- Nashville Tennessee Oncology — Nashville, Tennessee, United States
- Texas Oncology - South Austin — Austin, Texas, United States
- Texas Oncology The Woodlands, Gynecologic Oncology — The Woodlands, Texas, United States
- Texas Oncology - Tyler — Tyler, Texas, United States
- Edinburgh Cancer Centre — Edinburgh, United Kingdom
- Cancer Research UK Clinical Trial Unit — Glasgow, United Kingdom
- St Bartholomew's Hospital — London, United Kingdom
- University College London Hospital — London, United Kingdom
- Royal Marsden Hospital — London, United Kingdom
- Imperial College Healthcare NHS Trust — London, United Kingdom
- Oxford University Hospital Foundation Trust — Oxford, United Kingdom
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.