Back to resultsNUC-1031 in Patients With Platinum-Resistant Ovarian Cancer
Primary Purpose
Ovarian Cancer
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NUC-1031 500 mg
NUC-1031 750mg
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring Platinum-resistant, ovarian neoplasm, antineoplastic agents, ovarian diseases, cancer of the ovary
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Arizona Oncology Associates, PC - HAL
- Arizona Oncology Associates, PC - HOPE
- Rocky Mountain Cancer Centers, LLP
- Florida Cancer Specialists and Research Institute
- Minnesota Oncology Hematology, P.A.
- SCRI - HCA Health Midwest
- Nashville Tennessee Oncology
- Texas Oncology - South Austin
- Texas Oncology The Woodlands, Gynecologic Oncology
- Texas Oncology - Tyler
- Edinburgh Cancer Centre
- Cancer Research UK Clinical Trial Unit
- St Bartholomew's Hospital
- University College London Hospital
- Royal Marsden Hospital
- Imperial College Healthcare NHS Trust
- Oxford University Hospital Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A
Arm B
Arm Description
NUC-1031 500 mg/m2 administered on Days 1, 8, and 15 of 28-day cycles
NUC-1031 750 mg/m2 administered on Days 1, 8, and 15 of 28-day cycles
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03146663
Brief Title
NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer
Official Title
A Phase II Open-Label Study of NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why 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
Study Start Date
September 28, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NuCana plc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
Detailed Description
A total of 53 patients were randomized, of whom 51 patients were treated in Part I of the study, 24 patients in the 500 mg/m2 arm and 27 patients in the 750 mg/m2 arm. Eligible, consenting patients received NUC-1031 by IV infusion on Days 1, 8, and 15 of each 28-day cycle. Patients continued to receive NUC-1031 until the occurrence of disease progression and underwent imaging every 8 weeks. After disease progression, patients were followed for overall survival.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Platinum-resistant, ovarian neoplasm, antineoplastic agents, ovarian diseases, cancer of the ovary
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
NUC-1031 500 mg/m2 administered on Days 1, 8, and 15 of 28-day cycles
Arm Title
Arm B
Arm Type
Experimental
Arm Description
NUC-1031 750 mg/m2 administered on Days 1, 8, and 15 of 28-day cycles
Intervention Type
Drug
Intervention Name(s)
NUC-1031 500 mg
Other Intervention Name(s)
fosgemcitabine palabenamide
Intervention Description
NUC-1031 500 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
NUC-1031 750mg
Other Intervention Name(s)
fosgemcitabine palabenamide
Intervention Description
NUC-1031 750 mg/m2 on Days 1, 8, and 15 of a 28-day cycle
Primary Outcome Measure Information:
Title
Best Overall Response
Description
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.
Time Frame
Assessed from date of randomization until disease progression, up to end of the study (approximately 2 years)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth Oelmann, MD PhD
Organizational Affiliation
NuCana plc
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Oncology Associates, PC - HAL
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Arizona Oncology Associates, PC - HOPE
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Rocky Mountain Cancer Centers, LLP
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Florida Cancer Specialists and Research Institute
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Minnesota Oncology Hematology, P.A.
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435-2150
Country
United States
Facility Name
SCRI - HCA Health Midwest
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Nashville Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology - South Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Texas Oncology The Woodlands, Gynecologic Oncology
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Texas Oncology - Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Edinburgh Cancer Centre
City
Edinburgh
ZIP/Postal Code
EH4 2XR
Country
United Kingdom
Facility Name
Cancer Research UK Clinical Trial Unit
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
St Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Oxford University Hospital Foundation Trust
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared.
Learn more about this trial
NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer
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