Trial record 1 of 1 for:
SGI-110 hepatocellular carcinoma
SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC)
This study is currently recruiting participants.
Verified December 2012 by Astex Pharmaceuticals
Sponsor:
Astex Pharmaceuticals
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
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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 |
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: | May 2014 |
| Estimated Primary Completion Date: | October 2013 (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:
- 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
- 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 PSA or other cancer from which the subject has been disease free for at least three years
- 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 |
Locations
| United States, Washington | |
| Swedish Cancer Institute | Recruiting |
| Seattle, Washington, United States, 98122 | |
| Contact: Philip Gold, MD 206-386-2242 | |
| Principal Investigator: Philip Gold, MD | |
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: | December 27, 2012 |
| 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 May 22, 2013