NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer

February 16, 2021 updated by: NuCana plc

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XR
        • Edinburgh Cancer Centre
      • Glasgow, United Kingdom, G12 0YN
        • Cancer Research UK Clinical Trial Unit
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital
      • London, United Kingdom, W12 0HS
        • Imperial College Healthcare NHS Trust
      • London, United Kingdom, EC1A 7BE
        • St Bartholomew's Hospital
      • London, United Kingdom, NW1 2PG
        • University College London Hospital
      • Oxford, United Kingdom, OX3 7LE
        • Oxford University Hospital Foundation Trust
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Arizona Oncology Associates, PC - HAL
      • Tucson, Arizona, United States, 85711
        • Arizona Oncology Associates, PC - HOPE
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Rocky Mountain Cancer Centers, LLP
    • Florida
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists and Research Institute
    • Minnesota
      • Edina, Minnesota, United States, 55435-2150
        • Minnesota Oncology Hematology, P.A.
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • SCRI - HCA Health Midwest
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Nashville Tennessee Oncology
    • Texas
      • Austin, Texas, United States, 78745
        • Texas Oncology - South Austin
      • The Woodlands, Texas, United States, 77380
        • Texas Oncology The Woodlands, Gynecologic Oncology
      • Tyler, Texas, United States, 75702
        • Texas Oncology - Tyler

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • fosgemcitabine palabenamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed from date of randomization until disease progression, up to end of the study (approximately 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NuCana plc

Investigators

  • Study Director: Elisabeth Oelmann, MD PhD, NuCana plc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2017

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

May 4, 2017

First Submitted That Met QC Criteria

May 8, 2017

First Posted (Actual)

May 10, 2017

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-105
  • 2016-003287-39 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No IPD will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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