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SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC)

This study is currently recruiting participants.
Verified December 2012 by Astex Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Astex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01752933
First received: December 17, 2012
Last updated: December 27, 2012
Last verified: December 2012
History of Changes

December 17, 2012
December 27, 2012
December 2012
October 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01752933 on ClinicalTrials.gov Archive Site
  • 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.
  • 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, progression-free survival, overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Duration of response as measured in weeks. Progression-free survival and overall survival measured in weeks.
Not Provided
Not Provided
 
SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC)
A Phase 2 Study of SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC) Subjects Who Failed Prior Treatment With Sorafenib

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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinoma
Drug: SGI-110
SGI-110 will be administered by subcutaneously on Days 1 - 5 every 28 days until disease progression or unacceptable toxicity
Experimental: SGI-110
SGI-110 administered subcutaneously daily on Days 1 - 5 every 28 days
Intervention: Drug: SGI-110
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
46
May 2014
October 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Medpace Recruitment Center 1-866-872-2349
United States
 
NCT01752933
SGI-110-03
No
Astex Pharmaceuticals
Astex Pharmaceuticals
Not Provided
Not Provided
Astex Pharmaceuticals
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP