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NCT Number: NCT01752933

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

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of British Columbia and Vancouver General Hospital, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older
  • Histological or cytological confirmed hepatocellular carcinoma with advanced stage disease
  • 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
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Acceptable organ function
  • Signed an approved informed consent

Exclusion criteria

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

Treatment and study plan

SGI-110

Drug

SGI-110 will be administered by subcutaneously (SC) on Days 1 - 5 every 28 days until disease progression or unacceptable toxicity

Primary outcomes

  1. Disease Control Rate (DCR) at 16 Weeks for Patients Treated With Guadecitabine After Failure of Sorafenib

    Time frame: 16 weeks

    Percentage of patients achieving a best overall response of complete response (CR) or partial response (PR) plus subjects with stable disease at 16 weeks after the start of treatment. Response was assessed based on the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for target and non-target lesions using computed tomography (CT) or magnetic resonance imaging (MRI) as follows: Complete Response (CR), disappearance of all target lesions, disappearance of all non-target lesions, and normalization of tumor marker level; Partial Response (PR), at least a 30% decrease in the sum of diameters of target lesions from baseline; Progressive Disease (PD), at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions, and unequivocal progression of non-target lesions; Stable Disease, neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for PD (Eisenhauer et al. 2009, Eur. J. Cancer 45:228-247).

Secondary outcomes

  1. Safety and Tolerability of Guadecitabine

    Time frame: Varied by patient (median number of treatment cycles was 2.0 (range 2-8) in 60 mg/m^2 group, and 4.0 (range 1-13) in 45 mg/m^2 group

    Number of patients with serious adverse events and adverse events

  2. Alpha Fetoprotein Response as a Result of Guadecitabine Administration

    Time frame: Varied by patient (median number of treatment cycles was 2.0 (range 2-8) in 60 mg/m^2 group, and 4.0 (range 1-13) in 45 mg/m^2 group

    Percentage of patients with best post baseline alpha fetoprotein reduction of 50% or more

  3. Duration of Response

    Time frame: From time of first response until disease progression or date of death due to any cause, whichever occurred earlier; an average of 192 days.

    Duration of response as measured in days. Included subjects with a complete response or partial response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  4. Progression-free Survival

    Time frame: Through completion of response assessments (i.e., until disease progression or treatment discontinuation), an average of 112 days.

    Progression-free survival measured in days. Progression-free survival was defined as the time interval from the date of the first dose of study treatment to the earlier of 1) documented radiologic progression per RECIST v1.1 or clinical progression, or 2) death due to any cause.

  5. Overall Survival

    Time frame: Through completion of study survival follow-up, an average of 270 days.

    Overall survival measured in days.

Sponsors and collaborators

Lead sponsor

Astex Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase 2 Study of SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC) Subjects Who Failed Prior Treatment With Sorafenib

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 19, 2012
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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