A Phase 2 interventional study of NUC-1031 500 mg and NUC-1031 750mg in Ovarian Cancer, sponsored by NuCana plc. Terminated at 17 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-21.
Sponsored by NuCana plc · Phase 2, Interventional, and Treatment
Among 1,777 studies in Ovarian Neoplasms with a site in United States — 279 open to participants now, 454 under way, 46 of them phase 3. Ovarian Neoplasms · United States.
Among the 1,777 studies in Ovarian Neoplasms with a site in United States, this one is the 680th largest by enrollment of the 1,496 interventional ones that give a count, is one of 77 that started in 2017, is one of 485 in phase 2, and was the 1,037th registered.
3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.
Browse Ovarian Neoplasms studies →279 of the 1,777 studies in Ovarian Neoplasms with a site in United States are open now. Recruiting first, the newest first:
Michael J. Goodheart · Sites in United States
Ages 18–99 · Women only
Crescent Biopharma, Inc. · Sites in United States
Ages 18+
Merck Sharp & Dohme LLC · Sites in United States, Israel, Taiwan
Ages 18+ · Women only
University of Alabama at Birmingham · Sites in United States
Ages 18+
GE Healthcare · Sites in United States, Sweden
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 606 Ovarian Neoplasms studies recruiting now, 443 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,777 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 768 · Phase 2 718 · Phase 3 114 · Phase 4 8
First in 1980; this study’s year is marked. 77 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 53 is close to the median of 54 across 2,548 interventional studies indexed under Ovarian Neoplasms.
Median enrollment 47 across the 1,496 interventional studies, 176 across the 195 observational. Of the 1,208 that completed or were terminated, 445 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
712 of 1,777 have an industry lead sponsor. The 10 most frequent:
NuCana plc is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
NuCana plc has 1 study filed under Ovarian Neoplasms — fewer than ten, so there is no comparison to draw.
162 of the studies in Ovarian Neoplasms with a site in United States that are under way reach primary completion within a year, 9 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03815643Phase 3EMD Serono Research & Development Institute, Inc.Avelumab Program Rollover Study | 2026-11-24 |
| NCT05281471Phase 3Genelux CorporationEfficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076) | 2026-12 |
| NCT04498117Phase 3CanariaBio Inc.Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery | 2026-12-26 |
| NCT05059522Phase 3PfizerContinued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing | 2026-12-31 |
| NCT04095364Phase 3NRG OncologyLetrozole With or Without Paclitaxel and Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer | 2027-02-01 |
Among the 1,777 studies in Ovarian Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NUC-1031 500 mg/m2 administered on Days 1, 8, and 15 of 28-day cycles
Drug: NUC-1031 500 mg
NUC-1031 750 mg/m2 administered on Days 1, 8, and 15 of 28-day cycles
Drug: NUC-1031 750mg
NUC-1031 500 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
Also known as: fosgemcitabine palabenamide
NUC-1031 750 mg/m2 on Days 1, 8, and 15 of a 28-day cycle
Also known as: fosgemcitabine palabenamide
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.
Time frame: Assessed from date of randomization until disease progression, up to end of the study (approximately 2 years)
A total of 87 patients were screened, of whom 53 patients were randomized and 51 patients received at least one dose of NUC-1031. These 51 patients were included in the full analysis set and the safety analysis set.
| Milestone | Arm A | Arm B |
|---|---|---|
| Started | 25 | 28 |
| Completed | 24 | 27 |
| Not completed | 1 | 1 |
| Withdrew: Did not receive study treatment | 1 | 1 |
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.
| Participants | Arm A | Arm B |
|---|---|---|
| Complete response | 0 | 1 |
| Partial response | 2 | 0 |
| Stable disease | 8 | 8 |
| Progressive disease | 12 | 10 |
| Not evaluable | 1 | 2 |
| Missing | 1 | 5 |
Post-hoc analysis of best overall response to study treatment, as assessed by blinded independent central review according to RECIST v1.1, in the per protocol evaluable for response set of patients. Per protocol evaluable for response set is defined as all patients from the Full Analysis Set who had measurable disease at baseline, at least one post-baseline scan and who received a dose of NUC-1031 on all dosing days of Cycle 1.
| Participants | Arm A | Arm B |
|---|---|---|
| Complete response | 0 | 1 |
| Partial response | 2 | 0 |
| Stable disease | 6 | 1 |
| Progressive disease | 8 | 3 |
| Not evaluable | 1 | 0 |
Collected over Date of consent until 30 days after the last dose of study treatment, up to end of the study (approximately 2 years). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A | 21/24 (87.5%) | 8/24 (33.3%) | 24/24 (100%) |
| Arm B | 21/27 (77.8%) | 10/27 (37%) | 26/27 (96.3%) |
| Event | Arm A | Arm B |
|---|---|---|
| VomitingGastrointestinal disorders | 2/24 | 2/27 |
| ConstipationGastrointestinal disorders | 1/24 | 0/27 |
| Small intestinal obstructionGastrointestinal disorders | 1/24 | 0/27 |
| InfectionInfections and infestations | 1/24 | 1/27 |
| BacteraemiaInfections and infestations | 1/24 | 0/27 |
| Lung infectionInfections and infestations | 1/24 | 0/27 |
| PyrexiaGeneral disorders | 1/24 | 1/27 |
| Super vena cava syndromeVascular disorders | 1/24 | 0/27 |
| LeukocytosisBlood and lymphatic system disorders | 1/24 | 0/27 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/24 | 0/27 |
| Event | Arm A | Arm B |
|---|---|---|
| NauseaGastrointestinal disorders | 16/24 | 15/27 |
| FatigueGeneral disorders | 16/24 | 14/27 |
| VomitingGastrointestinal disorders | 12/24 | 12/27 |
| DiarrhoeaGastrointestinal disorders | 10/24 | 5/27 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 9/24 | 0/27 |
| ConstipationGastrointestinal disorders | 8/24 | 5/27 |
| AnaemiaBlood and lymphatic system disorders | 8/24 | 6/27 |
| PyrexiaGeneral disorders | 7/24 | 2/27 |
| Alanine aminotransferase increasedInvestigations | 7/24 | 6/27 |
| Decreased appetiteMetabolism and nutrition disorders | 7/24 | 6/27 |
| Age, Customized(Participants) | Arm A | Arm B | Total |
|---|---|---|---|
| <55 years | 6 | 4 | 10 |
| 55 - <66 years | 6 | 10 | 16 |
| 66 - 75 years | 9 | 10 | 19 |
| >75 years | 4 | 4 | 8 |
| Sex/Gender, Customized(Participants) | Arm A | Arm B | Total |
|---|---|---|---|
| Female | 25 | 28 | 53 |
| Ethnicity (NIH/OMB)(Participants) | Arm A | Arm B | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 24 | 28 | 52 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Arm A | Arm B | Total |
|---|---|---|---|
| Asian | 1 | 0 | 1 |
| Black/African American | 0 | 2 | 2 |
| White | 23 | 26 | 49 |
| Other | 1 | 0 | 1 |
| Original diagnosis(Participants) | Arm A | Arm B | Total |
|---|---|---|---|
| Ovarian | 16 | 20 | 36 |
| Fallopian tube | 4 | 2 | 6 |
| Primary peritoneal | 3 | 5 | 8 |
| Other | 2 | 0 | 2 |
| Not recorded | 0 | 1 | 1 |
| Metastatic disease(Participants) | Arm A | Arm B | Total |
|---|---|---|---|
| Yes | 25 | 26 | 51 |
| No | 0 | 1 | 1 |
| Not recorded | 0 | 1 | 1 |
| Time since initial diagnosis(years) | Arm A | Arm B | Total |
|---|---|---|---|
| Median | 4.3 (1.8 to 17.3) | 5.6 (1.7 to 15.6) | 5.0 (1.7 to 17.3) |
| Histology(Participants) | Arm A | Arm B | Total |
|---|---|---|---|
| High grade serous | 24 | 23 | 47 |
| High grade endometroid | 1 | 1 | 2 |
| Other | 0 | 3 | 3 |
| Not recorded | 0 | 1 | 1 |
9 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — No IPD will be shared.
Ran from Sep 2017 to primary completion in Dec 2019, 27 months.
Results were first posted in Feb 2021, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: NUC-1031
NuCana plc