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

Liver Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00247676
• Other study ID #: A6181055
• Status: Completed
• Phase: Phase 2
• First received: November 1, 2005
• Last updated: February 4, 2010
• Start date: February 2006
• Est. completion date: February 2009

Study information

• Verified date: February 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: February 2009
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Neoplasms
• Unresectable Hepatocellular Carcinoma

Intervention

Drug:
• Sunitinib (SU011248)
Sunitinib 50 mg by oral capsule, daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.

Locations

Country	Name	City	State
France	Pfizer Investigational Site	Clichy Cedex
France	Pfizer Investigational Site	Rennes Cedex
France	Pfizer Investigational Site	Saint Herrblain Cedex
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Taiwan	Pfizer Investigational Site	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

France,  Korea, Republic of,  Taiwan, 

Outcome

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

External Links

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