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An International Phase 2 Study Of SU011248 In Patients With Inoperable Liver Cancer

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

Condition(s) targeted: Liver Neoplasms; Unresectable Hepatocellular Carcinoma

Intervention: Sunitinib (SU011248) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


The study will consist of two parts. In Part 1 the study will start enrolling 38 patients and then further 25 patients up to a total of 63 eligible patients. If the study gives good results it can be expanded to a total of 160 patients. SU011248 will be administered orally daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg [milligrams] with provision for dose reduction based on tolerability. All patients will receive repeated cycles of SU011248 until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival

Clinical Details

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

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

Primary outcome:

Best Overall Response

Objective Response (CR or PR)

Secondary outcome:

Duration of Objective Response (CR or PR)

Clinical Benefit Response (CR, PR, or SD With Duration ≥12 Weeks)

Best Overall Response of PR or SD With Duration ≥12 Weeks

Progression-Free Survival (Overall ITT)

Progression-Free Survival (ITT Child Pugh Class A Subject Population)

Time to Tumor Progression (Overall ITT)

Time to Tumor Progression (ITT Child Pugh Class A Subject Population)

Overall Survival (Overall ITT)

Overall Survival (ITT Child Pugh Class A Subject Population)

1-Year Survival Probability

Trough Plasma Concentrations (Ctrough) of Sunitinib

Ctrough of SU-012662 (Metabolite of Sunitinib)

Ctrough of Total Drug (Sunitinib + SU-012662)

Dose-Corrected Ctrough of Sunitinib

Dose-Corrected Ctrough of SU-012662 (Metabolite of Sunitinib)

Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662)

Circulating Endothelial Cells (CECs) and Circulating Endothelial Progenitor Cells (CEPs)

Tissue Tumor Markers Assessed by Tumor Biopsy

Plasma Concentration of Vascular Endothelial Growth Factor (VEGF)

Plasma Concentration of VEGF-C

Plasma Concentration of Soluble VEGF Receptor-2 (sVEGFR-2)

Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3)

Plasma Concentration of Soluble KIT (sKIT)


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


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


- Known human immunodeficiency virus (HIV)

- Serious acute or chronic illness

- Current treatment on another clinical trial

- Pregnant or breastfeeding

Locations and Contacts

Pfizer Investigational Site, Clichy Cedex 92118, France

Pfizer Investigational Site, Rennes Cedex 4422935062, France

Pfizer Investigational Site, Saint Herrblain Cedex 44805, France

Pfizer Investigational Site, Seoul 110-744, Korea, Republic of

Pfizer Investigational Site, Seoul 135-710, Korea, Republic of

Pfizer Investigational Site, Seoul 138-736, Korea, Republic of

Pfizer Investigational Site, Seoul 152-703, Korea, Republic of

Pfizer Investigational Site, Taipei 110, Taiwan

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: February 2006
Last updated: February 4, 2010

Page last updated: August 23, 2015

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