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

This study is currently recruiting participants.
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

Resource links provided by NLM:


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

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

  Show 24 Study Locations
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 April 16, 2014