Ovarian CancerPhase 2NCT03146663
NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer
A Phase 2 study testing NUC-1031 500 mg and NUC-1031 750mg in people with Ovarian Cancer, run by NuCana plc at 17 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- NUC-1031 500 mg and NUC-1031 750mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 28 Sep 2017to 31 Dec 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States10 sites
Texas Oncology - South Austin
Austin, Texas, 78745
Minnesota Oncology Hematology, P.A.
Edina, Minnesota, 55435-2150
SCRI - HCA Health Midwest
Kansas City, Missouri, 64132
Rocky Mountain Cancer Centers, LLP
Lakewood, Colorado, 80228
Nashville Tennessee Oncology
Nashville, Tennessee, 37203
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, 85016
Florida Cancer Specialists and Research Institute
St. Petersburg, Florida, 33705
Texas Oncology The Woodlands, Gynecologic Oncology
The Woodlands, Texas, 77380
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, 85711
Texas Oncology - Tyler
Tyler, Texas, 75702
United Kingdom7 sites
Edinburgh Cancer Centre
Edinburgh, EH4 2XR
Cancer Research UK Clinical Trial Unit
Glasgow, G12 0YN
St Bartholomew's Hospital
London, EC1A 7BE
University College London Hospital
London, NW1 2PG
Royal Marsden Hospital
London, SW3 6JJ
Imperial College Healthcare NHS Trust
London, W12 0HS
Oxford University Hospital Foundation Trust
Oxford, OX3 7LE
About this study
Official title: A Phase II Open-Label Study of NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer
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).
Read the 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.
- Conditions
- Ovarian Cancer
- Being tested
- NUC-1031 500 mg, NUC-1031 750mg
- Keywords
- Platinum-resistant, ovarian neoplasm, antineoplastic agents, ovarian diseases, cancer of the ovary
- Medical subject headings
- Ovarian Neoplasms, Ovarian Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUC-1031 500 mgDrug
Also called fosgemcitabine palabenamide
NUC-1031 500 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
NUC-1031 750mgDrug
Also called fosgemcitabine palabenamide
NUC-1031 750 mg/m2 on Days 1, 8, and 15 of a 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | NUC-1031 500 mg/m2 administered on Days 1, 8, and 15 of 28-day cycles Receives: Drug: NUC-1031 500 mg |
| Arm B | Experimental | NUC-1031 750 mg/m2 administered on Days 1, 8, and 15 of 28-day cycles Receives: Drug: NUC-1031 750mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed from date of randomization until disease progression, up to end of the study (approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start28 Sep 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Why it 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuCana plc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth Oelmann, MD PhD, Study director, NuCana plc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146663
- Sponsor's protocol ID
- PRO-105
- Other IDs
- 2016-003287-39, 2016
- Status last verified
- Feb 2021
- First submitted
- 4 May 2017
- Last updated
- 21 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open-Label Study of NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03146663
- Acronym / sponsor ID
- PRO-105
- Conditions
- Ovarian Cancer
- Keywords
- Platinum-resistant, ovarian neoplasm, antineoplastic agents, ovarian diseases, cancer of the ovary
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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
- Enrolment
- 53 participants (actual)
- Lead sponsor
- NuCana plcUniversity, hospital or other
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 10 May 2017 (actual)
- Results
- Posted 21 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: NUC-1031 500 mgNUC-1031 500 mg/m2 administered on Days 1, 8, and 15 of 28-day cycles |
| Arm B | Experimental | Drug: NUC-1031 750mgNUC-1031 750 mg/m2 administered on Days 1, 8, and 15 of 28-day cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NUC-1031 500 mgAlso: fosgemcitabine palabenamideNUC-1031 500 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. | Drug | Arm A |
| NUC-1031 750mgAlso: fosgemcitabine palabenamideNUC-1031 750 mg/m2 on Days 1, 8, and 15 of a 28-day cycle | Drug | Arm B |
Primary outcome
Best Overall Response
Time frame: Assessed from date of randomization until disease progression, up to end of the study (approximately 2 years)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No IPD will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Oelmann, MD PhD study director
NuCana plc
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NUC-1031 500 mg and NUC-1031 750mg in people with Ovarian Cancer, run by NuCana plc at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Overall Response (time frame: Assessed from date of randomization until disease progression, up to end of the study (approximately 2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.