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NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03146663
Recruitment Status : Terminated (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)
First Posted : May 10, 2017
Results First Posted : February 21, 2021
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
NuCana plc

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).

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: NUC-1031 500 mg Drug: NUC-1031 750mg Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Open-Label Study of NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer
Actual Study Start Date : September 28, 2017
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: Arm A
NUC-1031 500 mg/m2 administered on Days 1, 8, and 15 of 28-day cycles
Drug: NUC-1031 500 mg
NUC-1031 500 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
Other Name: fosgemcitabine palabenamide

Experimental: Arm B
NUC-1031 750 mg/m2 administered on Days 1, 8, and 15 of 28-day cycles
Drug: NUC-1031 750mg
NUC-1031 750 mg/m2 on Days 1, 8, and 15 of a 28-day cycle
Other Name: fosgemcitabine palabenamide




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of signed written informed consent.
  2. Original diagnosis and/or histological confirmation of high-grade serous, high-grade endometrioid, undifferentiated/unclassifiable epithelial ovarian, fallopian tube or primary peritoneal cancer.
  3. Time from the last line of platinum-based chemotherapy of less than 6 months.
  4. Received at least 3 prior chemotherapy-containing regimens.
  5. Age ≥18 years.
  6. Ability to comply with protocol requirements.
  7. Patients are not of childbearing potential or they must agree to use a physical method of contraception.

Exclusion Criteria:

  1. Disease that progressed while receiving initial line of platinum-based chemotherapy.
  2. Received fewer than 3 prior chemotherapy-containing regimens.
  3. Prior therapy with single-agent gemcitabine.
  4. Prior history of hypersensitivity to gemcitabine.
  5. 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.
  6. Residual side effects from chemotherapy or radiation, which have not gotten better except for nerve pain or tingling or hair loss.
  7. 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.
  8. Presence of an serious illness, uncontrolled illness, or active infection requiring IV antibiotics.
  9. 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.
  10. Currently pregnant, lactating or breastfeeding.
  11. History of blocked intestines because of ovarian cancer, unless fully resolved.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03146663


Locations
Show Show 17 study locations
Sponsors and Collaborators
NuCana plc
Investigators
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Study Director: Elisabeth Oelmann, MD PhD NuCana plc
  Study Documents (Full-Text)

Documents provided by NuCana plc:
Study Protocol  [PDF] October 11, 2017
Statistical Analysis Plan  [PDF] May 26, 2020

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Responsible Party: NuCana plc
ClinicalTrials.gov Identifier: NCT03146663    
Other Study ID Numbers: PRO-105
2016-003287-39 ( EudraCT Number )
First Posted: May 10, 2017    Key Record Dates
Results First Posted: February 21, 2021
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NuCana plc:
Platinum-resistant
ovarian neoplasm
antineoplastic agents
ovarian diseases
cancer of the ovary
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type