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Trial record 47 of 163 for:    ovarian cancer and Minnesota

NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT03146663
Recruitment Status : Recruiting
First Posted : May 10, 2017
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 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 : June 30, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
Contacts and Locations

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


Contacts
Contact: Ruth Coy +44 7397009645 Ruth.Coy@chiltern.com

Locations
United States, Arizona
Arizona Oncology Associates, PC - HAL Recruiting
Scottsdale, Arizona, United States, 85016
Principal Investigator: Heather Dalton, MD         
Arizona Oncology Associates, PC - HOPE Recruiting
Tucson, Arizona, United States, 85711
Principal Investigator: Joseph Buscema, MD         
United States, California
University of California Not yet recruiting
Orange, California, United States, 92868
Contact       prumney@uci.edu   
Principal Investigator: Krishnansu Tewari, MD         
United States, Colorado
Rocky Mountain Cancer Centers, LLP Recruiting
Lakewood, Colorado, United States, 80228
Principal Investigator: Ling Ma, MD         
United States, Florida
Florida Cancer Affiliates - Ocala Recruiting
Ocala, Florida, United States, 34471
Principal Investigator: Samuel E Myrick, MD         
SCRI Not yet recruiting
Saint Petersburg, Florida, United States, 33705
Contact       rmccrery@flcancer.com   
Principal Investigator: Gail Wright, MD         
SCRI - Florida Recruiting
West Palm Beach, Florida, United States, 33401
Principal Investigator: Daniel Spitz, MD         
United States, Illinois
The University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
Contact       clandini@bsd.uchicago.edu   
Principal Investigator: John Moroney, MD         
United States, Minnesota
Minnesota Oncology Hematology, PA Recruiting
Edina, Minnesota, United States, 55435-2150
Principal Investigator: Jessica A Thomes-Pepin, MD         
United States, Missouri
SCRI - HCA Health Midwest Recruiting
Kansas City, Missouri, United States, 64132
Principal Investigator: Kristopher LyBarger, MD         
United States, Tennessee
Nashville Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact       Brittany.Goodloe@SarahCannon.com   
Principal Investigator: Erika Hamilton, MD         
United States, Texas
Texas Oncology - South Austin Recruiting
Austin, Texas, United States, 78745
Principal Investigator: Michael G Teneriello, MD         
Texas Oncology - Bedford Recruiting
Bedford, Texas, United States, 76022
Principal Investigator: Mark J Messing, MD         
SCRI - Ft Worth Recruiting
Fort Worth, Texas, United States, 76104
Principal Investigator: Prasnthi Ganesa, MD         
Texas Oncology - Fort Worth 12th Ave Recruiting
Fort Worth, Texas, United States, 76104
Principal Investigator: Noelle G Cloven, MD         
Texas Oncology - Tyler Recruiting
Tyler, Texas, United States, 75702
Principal Investigator: Donald A Richards, MD         
United States, Washington
Swedish Cancer Institue Not yet recruiting
Seattle, Washington, United States, 98104
Contact       Erik.Bailey@swedish.org   
Principal Investigator: Joshua Press, MD         
United Kingdom
Edinburgh Cancer Research UK Centre Recruiting
Edinburgh, United Kingdom
Contact       moira.stewart1@ed.ac.uk   
Principal Investigator: Charley M Gourley, MB ChB         
Cancer Research UK Clinical Trial Unit Recruiting
Glasgow, United Kingdom
Contact: Debbie Rai         
Contact       Debbie.Rai@ggc.scot.nhs.uk   
Principal Investigator: Patricia Roxburgh, MD         
ICR Royal Marsden Hospital Recruiting
London, United Kingdom
Contact       Kylie.Fitch@rmh.nhs.uk   
Principal Investigator: Susana Banerjee, MD         
Imperial College Healthcare Trust Recruiting
London, United Kingdom
Contact       Emily.Pickford@imperial.nhs.uk   
Principal Investigator: Jonathan Krell, MD         
St Bartholomew's Hospital Recruiting
London, United Kingdom
Contact       a.summers@qmul.ac.uk   
Principal Investigator: Rowan Miller, MD         
University College London Hospital Recruiting
London, United Kingdom
Contact       Didem.Agdiran@uclh.nhs.uk   
Principal Investigator: Michelle Lockley, MD         
Oxford University Hospitals Recruiting
Oxford, United Kingdom
Contact       trialadministrator02@oncology.ox.ac.uk   
Principal Investigator: Shibani Nicum, MD         
Sponsors and Collaborators
NuCana plc
Investigators
Study Director: Christopher B Wood, MD PhD NuCana plc
More Information

Responsible Party: NuCana plc
ClinicalTrials.gov Identifier: NCT03146663     History of Changes
Other Study ID Numbers: PRO-105
2016-003287-39 ( EudraCT Number )
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared.

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:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders