NCT00361309

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Apr 2006

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

1.6 years

First QC Date

August 4, 2006

Last Update Submit

March 16, 2014

Conditions

Hepatocellular CarcinomaLiver Cancer

Keywords

liver cancerHCC

Outcome Measures

Primary Outcomes (1)

  • Progression free survival of hepatocellular carcinoma (HCC) patients treated with SU011248.

    2 years

Secondary Outcomes (3)

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

    2 years

  • Objective Response Rate

    2 years

  • Overall Survival

    2 years

Study Arms (1)

SU011248

EXPERIMENTAL

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.

Drug: SU011248

Interventions

SU011248DRUG

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

Also known as: Sunitinib
SU011248

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed HCC and should have metastatic or locally advanced unresectable disease
  • Measurable disease
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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.

    PMID: 23842041DERIVED

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Andrew X. Zhu, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 4, 2006

First Posted

August 8, 2006

Study Start

April 1, 2006

Primary Completion

November 1, 2007

Study Completion

March 1, 2009

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations

US(3)