Study Stopped
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
NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer
A Phase II Open-Label Study of NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer
2 other identifiers
interventional
53
2 countries
17
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 ovarian-cancer
Started Sep 2017
Shorter than P25 for phase_2 ovarian-cancer
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2017
CompletedFirst Posted
Study publicly available on registry
May 10, 2017
CompletedStudy Start
First participant enrolled
September 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedResults Posted
Study results publicly available
February 21, 2021
CompletedFebruary 21, 2021
February 1, 2021
2.3 years
May 4, 2017
December 31, 2020
February 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best Overall Response
Best overall response to study treatment, as assessed by blinded independent central review according to RECIST v1.1, in the evaluable population of patients who received at least one dose of study treatment and had measurable disease at baseline. Complete Response (CR): disappearance of all target and non-target lesions, normalization of tumor markers, and pathological lymph nodes must have short axis measurements \<10 mm. Partial Response (PR): ≥30% decrease in the sum of measures of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-progressive disease. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters on study. Progressive Disease (PD): ≥20% increase in the sum of measured lesions taking as reference the smallest sum of diameters recorded on study and an absolute increase of ≥5mm.
Assessed from date of randomization until disease progression, up to end of the study (approximately 2 years)
Study Arms (2)
Arm A
EXPERIMENTALNUC-1031 500 mg/m2 administered on Days 1, 8, and 15 of 28-day cycles
Arm B
EXPERIMENTALNUC-1031 750 mg/m2 administered on Days 1, 8, and 15 of 28-day cycles
Interventions
NUC-1031 500 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
NUC-1031 750 mg/m2 on Days 1, 8, and 15 of a 28-day cycle
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NuCana plclead
Study Sites (17)
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, 85016, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, 85711, United States
Rocky Mountain Cancer Centers, LLP
Lakewood, Colorado, 80228, United States
Florida Cancer Specialists and Research Institute
St. Petersburg, Florida, 33705, United States
Minnesota Oncology Hematology, P.A.
Edina, Minnesota, 55435-2150, United States
SCRI - HCA Health Midwest
Kansas City, Missouri, 64132, United States
Nashville Tennessee Oncology
Nashville, Tennessee, 37203, United States
Texas Oncology - South Austin
Austin, Texas, 78745, United States
Texas Oncology The Woodlands, Gynecologic Oncology
The Woodlands, Texas, 77380, United States
Texas Oncology - Tyler
Tyler, Texas, 75702, United States
Edinburgh Cancer Centre
Edinburgh, EH4 2XR, United Kingdom
Cancer Research UK Clinical Trial Unit
Glasgow, G12 0YN, United Kingdom
St Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
University College London Hospital
London, NW1 2PG, United Kingdom
Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Imperial College Healthcare NHS Trust
London, W12 0HS, United Kingdom
Oxford University Hospital Foundation Trust
Oxford, OX3 7LE, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Medical and Scientific Affairs Department
- Organization
- NuCana Plc
Study Officials
- STUDY DIRECTOR
Elisabeth Oelmann, MD PhD
NuCana plc
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2017
First Posted
May 10, 2017
Study Start
September 28, 2017
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
February 21, 2021
Results First Posted
February 21, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share
No IPD will be shared.