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

This study has been completed.
Information provided by (Responsible Party):
Astex Pharmaceuticals Identifier:
First received: December 17, 2012
Last updated: January 24, 2017
Last verified: January 2017
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: Intervention Model: Single Group Assignment
Masking: No masking
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 ]
    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 ]
    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 ]
    Change in alpha fetoprotein levels from pre-treatment levels

  • Duration of response [ Time Frame: 18 months ]
    Duration of response as measured in weeks.

  • Progression-free survival [ Time Frame: 18 months ]
    Progression-free survival measured in weeks.

  • Overall survival [ Time Frame: 18 months ]
    Overall survival measured in weeks.

Enrollment: 51
Study Start Date: December 2012
Study Completion Date: September 2015
Primary Completion Date: September 2015 (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


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

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
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Please refer to this study by its identifier: NCT01752933

  Show 24 Study Locations
Sponsors and Collaborators
Astex Pharmaceuticals
  More Information

Responsible Party: Astex Pharmaceuticals Identifier: NCT01752933     History of Changes
Other Study ID Numbers: SGI-110-03
Study First Received: December 17, 2012
Last Updated: January 24, 2017

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors processed this record on April 28, 2017