SU011248 in Advanced Hepatocellular Carcinoma

• ClinicalTrials.gov Identifier: NCT00361309
• Recruitment Status: Completed
• First Posted: August 8, 2006
• Last Update Posted: March 18, 2014
• Sponsor: Massachusetts General Hospital
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Dana-Farber Cancer Institute
• Information provided by (Responsible Party): Andrew X. Zhu, MD, Massachusetts General Hospital

Tracking Information

• First Submitted Date: August 4, 2006
• First Posted Date: August 8, 2006
• Last Update Posted Date: March 18, 2014
• Study Start Date: April 2006
• Actual Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 16, 2014): Progression free survival of hepatocellular carcinoma (HCC) patients treated with SU011248. [ Time Frame: 2 years ]
• Original Primary Outcome Measures (submitted: August 4, 2006): To assess the progression free survival of hepatocellular carcinoma (HCC) patients treated with SU011248.
• Change History: Complete list of historical versions of study NCT00361309 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: March 16, 2014)

• Number of adverse events in patients treated with SU011248 for advanced hepatocellular carcinoma [ Time Frame: 2 years ]
• Objective Response Rate [ Time Frame: 2 years ]
• Overall Survival [ Time Frame: 2 years ]

Original Secondary Outcome Measures (submitted: August 4, 2006)

• To evaluate the toxicities of SU011248 in this patient population
• to evaluate the preliminary efficacy of SU011248 including response rate, duration of response, and overall survival in this population.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: SU011248 in Advanced Hepatocellular Carcinoma
• Official Title: A Phase II Study of SU011248 in Advanced Hepatocellular Carcinoma
• Brief 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.

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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Hepatocellular Carcinoma
• Liver Cancer

Intervention

Drug: SU011248

Patients will receive SU011248 37.5 mg/day for 4 weeks continuously followed by 2 weeks of rest per cycle (each cycle = 6 weeks).

Other Name: Sunitinib

Study Arms

Experimental: SU011248

Patients will receive SU011248 37.5 mg/day for 4 weeks continuously followed by 2 weeks of rest per cycle (each cycle = 6 weeks). Patients will be continued on treatment until disease progression, limiting toxicity, or patient withdrawal of consent.

Intervention: Drug: SU011248

• Publications *: Sahani DV, Jiang T, Hayano K, Duda DG, Catalano OA, Ancukiewicz M, Jain RK, Zhu AX. Magnetic resonance imaging biomarkers in hepatocellular carcinoma: association with response and circulating biomarkers after sunitinib therapy. J Hematol Oncol. 2013 Jul 10;6:51. doi: 10.1186/1756-8722-6-51.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 4, 2006): 34
• Original Enrollment: Same as current
• Actual Study Completion Date: March 2009
• Actual Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00361309
• Other Study ID Numbers: 05-348
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Andrew X. Zhu, MD, Massachusetts General Hospital
• Study Sponsor: Massachusetts General Hospital

Collaborators

• Beth Israel Deaconess Medical Center
• Brigham and Women's Hospital
• Dana-Farber Cancer Institute

Investigators

• Principal Investigator: Andrew X. Zhu, MD; Massachusetts General Hospital

• PRS Account: Massachusetts General Hospital
• Verification Date: March 2014