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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. Identifier: NCT03146663
Recruitment Status : Terminated (Despite the clinical activity observed, the study was stopped due to reduced dose intensity in this heavily pre-treated population with complex comorbidities)
First Posted : May 10, 2017
Last Update Posted : January 14, 2020
Information provided by (Responsible Party):
NuCana plc

Brief Summary:
This study will evaluate the effect of two dose levels of NUC-1031 (500 mg/m2 and 750mg/m2) in patients with ovarian cancer. The primary objective is 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:

Up to 20 patients will be treated at each dose in Part I of the study. In Part II of the study, one of the treatment dose levels will be selected for further evaluation. The dose selection will be based on clinical and laboratory assessments of patients recruited in Part I. Patients will only participate in either Part I or II. A total of 64 patients will be treated in Part I and Part II combined.

Eligible consenting patients will receive NUC-1031 by IV infusion on days 1, 8 and 15 of each 28-day cycle. Patients will continue to receive NUC-1031 until the occurrence of disease progression. Patients will undergo imaging every 8 weeks. After disease progression, patients will be followed for overall survival.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 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: NUC-1031 500 mg/m2
NUC-1031 500 mg/m2 on days 1, 8, and 15
Drug: NUC-1031 500 mg
NUC-1031 500 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.

Experimental: NUC-1031 750 mg/m2
NUC-1031 750 mg/m2 on Days 1, 8, and 15
Drug: NUC-1031 750mg
NUC-1031 750 mg/m2 on Days 1, 8, and 15 of a 28-day cycle

Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Assessed at approximately 24 weeks following the last patient enrolled ]
    ORR is defined as the number of patients achieving a confirmed response (CR or PR).

Secondary Outcome Measures :
  1. Change from baseline in tumor size [ Time Frame: Assessed every 8 weeks for up to 36 months ]
    The percentage change in the total measurement of target lesions from the pre-treatment scan to the total measurement of target lesions at each scheduled scan

  2. Progression-Free Survival (per RECIST) [ Time Frame: Assessed every 8 weeks for up to 36 months ]
    Progression-free survival will be calculated from the start of treatment to the date of progression or death from any cause

  3. Overall Survival [ Time Frame: Assessed every 12 weeks following disease progression for up to 36 months ]
    Overall survival will be calculated from the start of treatment to the date of death from any cause

  4. Treatment-emergent adverse events (per NCI CTCAE v4), changes in vitals signs and laboratory parameters [ Time Frame: Assessed from the time of consent until 30 days following the last NUC-1031 dose administration ]
    Evaluation of safety and tolerability of NUC-1031

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT03146663

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Sponsors and Collaborators
NuCana plc
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Study Director: Christopher B Wood, MD PhD NuCana plc
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Responsible Party: NuCana plc Identifier: NCT03146663    
Other Study ID Numbers: PRO-105
2016-003287-39 ( EudraCT Number )
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
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:
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
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type