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SU011248 in Advanced Hepatocellular Carcinoma

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatocellular Carcinoma; Liver Cancer

Intervention: SU011248 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Andrew X. Zhu, MD, Principal Investigator, Affiliation: Massachusetts General Hospital

Summary

The main purpose of this study is to begin to collect information and try to learn whether SU011248 works in treating patients with advanced liver cancer. Laboratory studies have shown that SU011248 may block the growth of blood vessels in tumors, which may prevent tumors from growing any further.

Clinical Details

Official title: A Phase II Study of SU011248 in Advanced Hepatocellular Carcinoma

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

Primary outcome: Progression free survival of hepatocellular carcinoma (HCC) patients treated with SU011248.

Secondary outcome:

Number of adverse events in patients treated with SU011248 for advanced hepatocellular carcinoma

Objective Response Rate

Overall Survival

Detailed description:

- Participants will be given a supply of SU011248 capsules to be taken orally every

morning for 4 weeks. After taking SU011248 for 4 weeks, there will be a 2 week rest period when the participant will not take any capsules. This 6-week period is referred to as 1 cycle.

- Participants will continue to receive SU011248 study treatment as long as their disease

does not worsen significantly and they are not experiencing any serious side effects.

- During cycle 1 of study treatment, the participant will come to the outpatient clinic

once a week for blood work, physical examination and dynamic contrast enhanced magnetic resonance imaging (DCE-MRI), which is done two weeks after they start taking study treatment.

- During cycle two and every cycle thereafter, the participant will be asked to come to

the outpatient clinic once every two weeks for physical examination, blood work and urine tests.

- A CT scan or MRI scan to assess the tumor will be performed once during each cycle for

the first three cycles, then once every 2 cycles thereafter. ACTH stimulation test will be done every 2 cycles. A MUGA scan may be done at anytime at the discretion of the the study doctor.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Histologically or cytologically confirmed HCC and should have metastatic or locally

advanced unresectable disease

- Measurable disease

- 0-1 prior systemic chemotherapy regimens for HCC

- Age 18 years or older

- Life expectancy of greater than 12 weeks

- ECOG performance status of 0-1

- Adequate organ and marrow function

- Women of child-bearing potential must have a negative pregnancy test prior to study

entry Exclusion Criteria:

- Chemotherapy, radiotherapy or major surgery within 4 weeks of study entry

- Receiving any other investigational agents within past 30 days

- Known brain metastases

- CLIP score > 3

- Chronic diarrhea or any disorder that will limit adequate absorption of SU011248

- Prolongation of QTc > 450 msec in screening electrocardiogram or history of familial

long QT syndrome

- Uncontrolled intercurrent illness

- Pregnant or lactating women

- Greater than or equal to 2g of protein/24hr

Locations and Contacts

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02115, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

Additional Information

Starting date: April 2006
Last updated: March 16, 2014

Page last updated: August 23, 2015

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