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NCT03146663

NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer

Terminated Phase 2 Results posted Last updated 21 February 2021
What this trial tests

Phase 2 trial testing NUC-1031 500 mg in Ovarian Cancer in 53 participants. Terminated before completion.

Timeline
28 September 2017
Primary endpoint
31 December 2019
31 December 2019

Quick facts

Lead sponsorNuCana plc
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment53
Start date28 September 2017
Primary completion31 December 2019
Estimated completion31 December 2019
Sites17 locations across United Kingdom, United States

Drugs / interventions tested

Conditions studied

Sponsor

NuCana plc — full company profile →

Who can join

18 and older, female only, with Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Best Overall Response Primary · 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-progressi

GroupValue95% CI
Arm A0
Arm B1
Arm A2
Arm B0
Arm A8
Arm B8
Arm A12
Arm B10
Best Overall Response (in Evaluable for Response Set) Secondary · Assessed from date of randomization until disease progression, up to end of the study (approximately 2 years)

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.

GroupValue95% CI
Arm A0
Arm B1
Arm A2
Arm B0
Arm A6
Arm B1
Arm A8
Arm B3

Adverse events — posted to ClinicalTrials.gov

Time frame: Date of consent until 30 days after the last dose of study treatment, up to end of the study (approximately 2 years). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm A
Serious: 8/24 (33%)
Deaths: 21/24
Arm B
Serious: 10/27 (37%)
Deaths: 21/27

Serious adverse events (21 terms)

ReactionSystemArm AArm B
VomitingGastrointestinal disorders
ConstipationGastrointestinal disorders
DiarrhoeaGastrointestinal disorders
NauseaGastrointestinal disorders
Rectal haemorrhageGastrointestinal disorders
Small intestinal obstructionGastrointestinal disorders
InfectionInfections and infestations
BacteraemiaInfections and infestations
InfluenzaInfections and infestations
Lower respiratory tract infectionInfections and infestations
Lower respiratory tract infection bacterialInfections and infestations
Lung infectionInfections and infestations
Respiratory tract infection viralInfections and infestations
SepsisInfections and infestations
Urinary tract infectionInfections and infestations
PyrexiaGeneral disorders
AstheniaGeneral disorders
HypotensionVascular disorders
Super vena cava syndromeVascular disorders
LeukocytosisBlood and lymphatic system disorders
Pulmonary embolismRespiratory, thoracic and mediastinal disorders
Other adverse events (47 terms — click to expand)

ReactionSystemArm AArm B
NauseaGastrointestinal disorders
FatigueGeneral disorders
VomitingGastrointestinal disorders
DiarrhoeaGastrointestinal disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders
ConstipationGastrointestinal disorders
AnaemiaBlood and lymphatic system disorders
PyrexiaGeneral disorders
Alanine aminotransferase increasedInvestigations
Decreased appetiteMetabolism and nutrition disorders
Aspartate aminotransferase increasedInvestigations
Neutrophil count decreasedInvestigations
NeutropaeniaBlood and lymphatic system disorders
CoughRespiratory, thoracic and mediastinal disorders
Abdominal PainGastrointestinal disorders
ThrombocytopaeniaBlood and lymphatic system disorders
DehydrationMetabolism and nutrition disorders
Abdominal distensionGastrointestinal disorders
Oedema peripheralGeneral disorders
HypomagnesaemiaMetabolism and nutrition disorders
DizzinessNervous system disorders
HeadacheNervous system disorders
Urinary tract infectionInfections and infestations
Muscle spasmsMusculoskeletal and connective tissue disorders
AscitesGastrointestinal disorders
Blood alkaline phosphatase increasedInvestigations
White blood cell count decreasedInvestigations
HypoalbuminaemiaMetabolism and nutrition disorders
Back painMusculoskeletal and connective tissue disorders
Vision blurredEye disorders
DysuriaRenal and urinary disorders
TachycardiaCardiac disorders
DyspepsiaGastrointestinal disorders
StomatitisGastrointestinal disorders
Abdominal pain lowerGastrointestinal disorders
AstheniaGeneral disorders
Chest discomfortGeneral disorders
Influenza like illnessGeneral disorders
Mucosal inflammationGeneral disorders
Gamma-glutamyltransferase increasedInvestigations

Most-reported serious reactions: Vomiting, Constipation, Diarrhoea, Nausea, Rectal haemorrhage, Small intestinal obstruction, Infection, Bacteraemia.

Data from ClinicalTrials.gov NCT03146663 adverse events section.

Sponsor's own description

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).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Bringing new medicines to women with epithelial ovarian cancer: what is the unmet medical need?
    Herzog TJ, Monk BJ. · · 2017 · cited 26× · PMID 28904804 · DOI 10.1186/s40661-017-0050-0
  2. Development of new medical treatment for epithelial ovarian cancer recurrence.
    Mancari R, Cutillo G, Bruno V, Vincenzoni C, et al · · 2020 · cited 19× · PMID 32953630 · DOI 10.21037/gs-20-413
  3. Comparative Pharmacology of a Bis-Pivaloyloxymethyl Phosphonate Prodrug Inhibitor of Enolase after Oral and Parenteral Administration.
    Yan VC, Barekatain Y, Lin YH, Satani N, et al · · 2023 · cited 3× · PMID 36798479 · DOI 10.1021/acsptsci.2c00216
  4. Defining the mode of action of cisplatin combined with NUC-1031, a phosphoramidate modification of gemcitabine.
    Patel D, Dickson AL, Zickuhr GM, Um IH, et al · · 2024 · cited 2× · PMID 39299019 · DOI 10.1016/j.tranon.2024.102114

Verify or expand the search:

Other recruiting trials for Ovarian Cancer

Currently open trials in the same condition.

Other NuCana plc trials

Trials by the same sponsor.

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