Trial record 1 of 1 for:    SGI-110 hepatocellular carcinoma
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SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Astex Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Astex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01752933
First received: December 17, 2012
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

A Phase 2 open-label, single-arm, non-randomized study in the treatment of advanced hepatocellular carcinoma (HCC) patients who failed prior treatment with sorafenib using a Simon's 2-stage design. A set minimum number of patients must demonstrate disease control at 16 weeks to proceed to Stage 2. At Stage 2, a set number of patients must have disease control at 16 weeks to declare that SGI-110 is of interest in the treatment of advanced HCC after failure of prior sorafenib.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: SGI-110
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC) Subjects Who Failed Prior Treatment With Sorafenib

Further study details as provided by Astex Pharmaceuticals:

Primary Outcome Measures:
  • Assess the disease control rate (DCR) at 16 weeks for patients treated with SGI-110 after failure of sorafenib [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Percentage of patients achieving a best overall response of complete response or partial response and stable disease at 16 weeks


Secondary Outcome Measures:
  • Assess safety and tolerability of SGI-110 [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Number of patients with serious adverse events and adverse events

  • Determine alpha fetoprotein response as a result of SGI-110 administration [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Change in alpha fetoprotein levels from pre-treatment levels

  • Duration of response [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Duration of response as measured in weeks.

  • Progression-free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Progression-free survival measured in weeks.

  • Overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Overall survival measured in weeks.


Estimated Enrollment: 46
Study Start Date: December 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SGI-110
SGI-110 administered subcutaneously daily on Days 1 - 5 every 28 days
Drug: SGI-110
SGI-110 will be administered by subcutaneously on Days 1 - 5 every 28 days until disease progression or unacceptable toxicity

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or older
  2. Histological or cytological confirmed hepatocellular carcinoma with advanced stage disease
  3. Received prior sorafenib treatment, and showed evidence of disease progression, which is defined as Investigator verified radiologic progression, or intolerance of prior systemic therapy, which is defined as having had clinically significant adverse events that persisted despite one or more dose reductions or interruptions
  4. ECOG performance status of 0-1
  5. Acceptable organ function
  6. Signed an approved informed consent

Exclusion Criteria:

  1. Known hypersensitivity to SGI-110
  2. Adequate washout of prior radiation, chemotherapy or other locoregional therapy
  3. Abnormal left ventricular ejection fraction
  4. Uncontrolled ischemic heart disease or a history of congestive cardiac failure
  5. Known brain metastases
  6. Clinically evident ascites
  7. Child-Pugh C cirrhosis or Child-Pugh B cirrhosis with more than 7 points
  8. Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, non-metastatic prostate cancer with normal PSA or other cancer from which the subject has been disease free for at least three years
  9. Known history of human immunodeficiency virus (HIV)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752933

Contacts
Contact: Medpace Recruitment Center 1-866-872-2349

  Hide Study Locations
Locations
United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Carol Rose    626-359-8111 ext 68245    crose@coh.org   
Principal Investigator: Marwan Fakih, MD         
USC Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Dana Agafitei    323-865-0467    Raluca.agafitei@med.usc.edu   
Principal Investigator: Anthony El-Khoueiry, MD         
UC Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Christina Romo    916-734-1455    christina.romo@ucdmc.ucdavis.edu   
Principal Investigator: Thomas Semrad, MD         
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: David Daniels    813-745-3960    david.daniels@moffitt.org   
Principal Investigator: Richard Kim, MD         
United States, Illinois
Northwestern University: Robert H. Lurie Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60611
Contact: Erin Alonso    312-695-4168    erin.alonso@northwestern.edu   
Principal Investigator: Mary Mulcahy, MD         
United States, Kentucky
University of Louisville James Graham Brown Cancer Center Not yet recruiting
Louisville, Kentucky, United States, 40201
Principal Investigator: Vivek Sharma, MD         
United States, New York
Columbia University Medical Center - Herbert Irving Comprehensive Cancer Center Recruiting
New York, New York, United States, 10032
Contact: Victoria Vulaj    212-342-0248    vv2218@cumc.columbia.edu   
Principal Investigator: Abby Siegel, MD         
United States, Ohio
The Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Sanaa Tahiri    614-293-5894    sanaa.tahiri@osumc.edu   
Principal Investigator: Tanios Bekaii-Saab, MD         
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Rebecca Marlow    215-214-1451    Becky.marlow@fccc.edu   
Contact: Alexis Dickens    215-214-3916    alexis.dickens@fccc.edu   
Principal Investigator: Crystal Denlinger, MD         
United States, South Carolina
Medical University of South Carolina, Hollings Cancer Center Recruiting
Charleston, South Carolina, United States, 29425
Contact: Andie Adelman    843-792-1507    adelman@musc.edu   
Principal Investigator: Melanie Thomas, MD         
United States, Tennessee
The Jones Clinic, PC Recruiting
Germantown, Tennessee, United States, 38138
Contact: Lori Lynch    901-685-5969 ext 322    llynch@jonescancerclinic.com   
Principal Investigator: Michael C Jones, MD         
United States, Texas
Mary Crowley Medical Research Center Recruiting
Dallas, Texas, United States, 75230
Contact    972-566-3000    referral@marycrowley.org   
Principal Investigator: John Nemunaitis, MD         
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Tyson Dudley    214-648-7031    tyson.dudley@utsouthwestern.edu   
Principal Investigator: Muhammad Beg, MD         
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98122
Contact: Philip Gold, MD    206-386-2242      
Principal Investigator: Philip Gold, MD         
United States, Wisconsin
UW Carbone Cancer Center Recruiting
Madison, Wisconsin, United States, 53792
Contact: Rachel Crawford    608-265-4347    recrawford@uwcarbone.wisc.edu   
Principal Investigator: William Schelman, MD         
Canada, British Columbia
University of British Columbia and Vancouver General Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Principal Investigator: Alan Weiss, MD         
Canada, Ontario
The Ottawa Hospital Cancer Center Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Diane Lister    613-737-7700 ext 70305    dilister@ohri.ca   
Principal Investigator: Rakesh Goel, MD         
Sunnybrook HealthScience Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Adam Lam    416-480-5000 ext 7868    adam.lam@sunnybrook.ca   
Principal Investigator: Yoo-Joung Ko, MD         
Canada, Quebec
CHUM Hopital St-Luc Recruiting
Montreal, Quebec, Canada, H2X 3J4
Contact: Stephanie Girard    514-890-8000 ext 35281    stephanie.girard.chum@ssss.gouv.qc.ca   
Principal Investigator: Helene Castel         
Centre Hospitalier Universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1N 5N4
Contact: Marc-Andre Rodrigue    819-346-1110    marodrigue.chus@ssss.gouv.qc.ca   
Principal Investigator: Annie Beaudoin, MD         
United Kingdom
University of Liverpool Clatterbridge Cancer Center Not yet recruiting
Liverpool, United Kingdom
Principal Investigator: Daniel Palmer         
University College London Not yet recruiting
London, United Kingdom, WC1E 6BT
Principal Investigator: Tim Meyer         
Imperial College Healthcare NHS Foundation Trust Not yet recruiting
London, United Kingdom, W12 0NN
Principal Investigator: Rohini Sharma, MD         
Cambridge University Hospitals NHS Foundation Trust Not yet recruiting
London, United Kingdom, EC1V 4AD
Principal Investigator: Bristi Basu, MD         
Sponsors and Collaborators
Astex Pharmaceuticals
  More Information

No publications provided

Responsible Party: Astex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01752933     History of Changes
Other Study ID Numbers: SGI-110-03
Study First Received: December 17, 2012
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 24, 2014