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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess the disease control rate (DCR) at 16 weeks for patients treated with SGI-110 after failure of sorafenib

Outcome Description:

Percentage of patients achieving a best overall response of complete response or partial response and stable disease at 16 weeks

Outcome Time Frame:

18 months

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

SGI-110-03

NCT ID:

NCT01752933

Start Date:

December 2012

Completion Date:

May 2014

Related Keywords:

  • Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location

Swedish Cancer InstituteSeattle, Washington  98104