An International Phase 2 Study Of SU011248 In Patients With Inoperable Liver Cancer - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00247676

Purpose

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

Condition	Intervention	Phase
Liver Neoplasms Unresectable Hepatocellular Carcinoma	Drug: Sunitinib (SU011248)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open Label International Multi-Center Phase 2 Activity And Safety Study Of SU011248 In Patients With Unresectable Hepatocellular Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer

Drug Information available for: Sunitinib malate Sunitinib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Best Overall Response [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter ] [ Designated as safety issue: No ]
Objective Response (CR or PR) [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of Objective Response (CR or PR) [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death due to cancer ] [ Designated as safety issue: No ]
Clinical Benefit Response (CR, PR, or SD With Duration ≥12 Weeks) [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or SD with duration of at least 12 weeks on study ] [ Designated as safety issue: No ]
Best Overall Response of PR or SD With Duration ≥12 Weeks [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or SD with duration of at least 12 weeks or death due to cancer ] [ Designated as safety issue: No ]
Progression-Free Survival (Overall ITT) [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death ] [ Designated as safety issue: No ]
Progression-Free Survival (ITT Child Pugh Class A Subject Population) [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death ] [ Designated as safety issue: No ]
Time to Tumor Progression (Overall ITT) [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter ] [ Designated as safety issue: No ]
Time to Tumor Progression (ITT Child Pugh Class A Subject Population) [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter ] [ Designated as safety issue: No ]
Overall Survival (Overall ITT) [ Time Frame: From start of study treatment until death. ] [ Designated as safety issue: No ]
Overall Survival (ITT Child Pugh Class A Subject Population) [ Time Frame: From start of study treatment until death. ] [ Designated as safety issue: No ]
1-Year Survival Probability [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter up until 1 year. ] [ Designated as safety issue: No ]
Trough Plasma Concentrations (Ctrough) of Sunitinib [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) ] [ Designated as safety issue: No ]
Ctrough of SU-012662 (Metabolite of Sunitinib) [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) ] [ Designated as safety issue: No ]
Ctrough of Total Drug (Sunitinib + SU-012662) [ Time Frame: Cycle 1 (Days 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) ] [ Designated as safety issue: No ]
Dose-Corrected Ctrough of Sunitinib [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) ] [ Designated as safety issue: No ]
Dose-Corrected Ctrough of SU-012662 (Metabolite of Sunitinib) [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) ] [ Designated as safety issue: No ]
Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662) [ Time Frame: Cycle 1 (Days 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) ] [ Designated as safety issue: No ]
Circulating Endothelial Cells (CECs) and Circulating Endothelial Progenitor Cells (CEPs) [ Time Frame: Cycle 1 (Days 1, 14), Cycle 2 (Days 1, 28), Cycle 5 (Day 1) ] [ Designated as safety issue: No ]
Tissue Tumor Markers Assessed by Tumor Biopsy [ Time Frame: Day 28 of Cycle 1 (optional) ] [ Designated as safety issue: No ]
Plasma Concentration of Vascular Endothelial Growth Factor (VEGF) [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28) ] [ Designated as safety issue: No ]
Plasma Concentration of VEGF-C [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28) ] [ Designated as safety issue: No ]
Plasma Concentration of Soluble VEGF Receptor-2 (sVEGFR-2) [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28) ] [ Designated as safety issue: No ]
Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3) [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28) ] [ Designated as safety issue: No ]
Plasma Concentration of Soluble KIT (sKIT) [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28) ] [ Designated as safety issue: No ]

Enrollment:	37
Study Start Date:	February 2006
Study Completion Date:	February 2009
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: Sunitinib (SU011248) Sunitinib 50 mg by oral capsule, daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity. Other Name: SU011248, Sutent

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247676

Locations

France
Pfizer Investigational Site
Clichy Cedex, France, 92118
Pfizer Investigational Site
Rennes Cedex, France, 4422935062
Pfizer Investigational Site
Saint Herrblain Cedex, France, 44805
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 135-710
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Pfizer Investigational Site
Seoul, Korea, Republic of, 152-703
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Taiwan
Pfizer Investigational Site
Taipei, Taiwan, 110

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Harmon CS, DePrimo SE, Raymond E, Cheng AL, Boucher E, Douillard JY, Lim HY, Kim JS, Lechuga MJ, Lanzalone S, Lin X, Faivre S. Mechanism-related circulating proteins as biomarkers for clinical outcome in patients with unresectable hepatocellular carcinoma receiving sunitinib. J Transl Med. 2011 Jul 25;9:120.

Faivre S, Zappa M, Vilgrain V, Boucher E, Douillard JY, Lim HY, Kim JS, Im SA, Kang YK, Bouattour M, Dokmak S, Dreyer C, Sablin MP, Serrate C, Cheng AL, Lanzalone S, Lin X, Lechuga MJ, Raymond E. Changes in tumor density in patients with advanced hepatocellular carcinoma treated with sunitinib. Clin Cancer Res. 2011 Jul 1;17(13):4504-12. Epub 2011 Apr 29.

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier:	NCT00247676 History of Changes
Other Study ID Numbers:	A6181055
Study First Received:	November 1, 2005
Results First Received:	January 6, 2010
Last Updated:	February 4, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Liver neoplasms, sunitinib, Phase 2

Additional relevant MeSH terms:

Neoplasms
Carcinoma
Liver Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

Adenocarcinoma
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012