Know Cancer

or
forgot password

An Open Label International Multi-Center Phase 2 Activity And Safety Study Of SU011248 In Patients With Unresectable Hepatocellular Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Neoplasms, Unresectable Hepatocellular Carcinoma

Thank you

Trial Information

An Open Label International Multi-Center Phase 2 Activity And Safety Study Of SU011248 In Patients With Unresectable Hepatocellular Carcinoma


Inclusion Criteria:



- Histologically confirmed diagnosis of hepatocellular carcinoma

- Patients must present with disease not amenable to curative surgery (i.e. either
hepatectomy, or liver transplant).

- Evidence of measurable disease by radiographic technique

- Adequate organ function.

Exclusion Criteria:

- Prior treatment with any systemic treatment for liver cancer

- Presence of clinically relevant ascites

- Severe hemorrhage <4 weeks of starting study treatment.

- Diagnosis of second malignancy within last 3 years

- History of or known brain metastases, spinal cord compression, or carcinomatous
meningitis

- Known human immunodeficiency virus (HIV)

- Serious acute or chronic illness

- Current treatment on another clinical trial

- Pregnant or breastfeeding

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Best Overall Response

Outcome Time Frame:

From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A6181055

NCT ID:

NCT00247676

Start Date:

February 2006

Completion Date:

February 2009

Related Keywords:

  • Liver Neoplasms
  • Unresectable Hepatocellular Carcinoma
  • Liver neoplasms, sunitinib, Phase 2
  • Neoplasms
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location