NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer
NCT ID: NCT03146663
Last Updated: 2021-02-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
53 participants
INTERVENTIONAL
2017-09-28
2019-12-31
Brief Summary
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Detailed Description
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Part II of the study was designed to select one of the treatment dose levels for further evaluation based on clinical and laboratory assessments of patients recruited in Part I. Despite promising efficacy and a good tolerability profile in Part I, it was decided not to initiate Part II as the pre-specified boundary for efficacy was uncertain to be met in this heavily pre-treated population with significant co-morbidities.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
NUC-1031 500 mg/m2 administered on Days 1, 8, and 15 of 28-day cycles
NUC-1031 500 mg
NUC-1031 500 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
Arm B
NUC-1031 750 mg/m2 administered on Days 1, 8, and 15 of 28-day cycles
NUC-1031 750mg
NUC-1031 750 mg/m2 on Days 1, 8, and 15 of a 28-day cycle
Interventions
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NUC-1031 500 mg
NUC-1031 500 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
NUC-1031 750mg
NUC-1031 750 mg/m2 on Days 1, 8, and 15 of a 28-day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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NuCana plc
OTHER
Responsible Party
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Principal Investigators
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Elisabeth Oelmann, MD PhD
Role: STUDY_DIRECTOR
NuCana plc
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-003287-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PRO-105
Identifier Type: -
Identifier Source: org_study_id
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