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

NCT00247676 | Completed Phase 2 Results

• 1 other identifier: A6181055
• Study Type: interventional
• Target: 37
• Locations: 3 countries
• Sites: 8

Brief 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

Conditions

Liver Neoplasms; Unresectable Hepatocellular Carcinoma

Keywords

Liver neoplasms, sunitinib, Phase 2

Outcome Measures

Primary Outcomes (2)

• Best Overall Response

  Number of subjects with best overall response. Complete response (CR)=disappearance of all target lesions. Partial Response (PR)= ≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD)= ≥ 20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of ≥ 1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.

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

• Objective Response (CR or PR)

  Number of patients with objective response: confirmed CR or confirmed PR according to RECIST. CR was defined as the disappearance of all target lesions. A PR was defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. To be assigned a status of PR or CR, changes in tumor measurements in patients with responding tumors had to have been confirmed by repeat studies that were performed ≥ 4 weeks after the criteria for response were first met.

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

Secondary Outcomes (23)

• 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

• 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

• 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

• Progression-Free Survival (Overall ITT)

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

• 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

Study Arms (1)

A

EXPERIMENTAL

Drug: Sunitinib (SU011248)

Interventions

Sunitinib (SU011248) DRUG

Sunitinib 50 mg by oral capsule, daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.

Also known as: SU011248, Sutent

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (8)

Pfizer Investigational Site

Clichy, 92118, France

Location

Pfizer Investigational Site

Rennes, 4422935062, France

Location

Pfizer Investigational Site

Saint Herrblain Cedex, 44805, France

Location

Pfizer Investigational Site

Seoul, 110-744, South Korea

Location

Pfizer Investigational Site

Seoul, 135-710, South Korea

Location

Pfizer Investigational Site

Seoul, 138-736, South Korea

Location

Pfizer Investigational Site

Seoul, 152-703, South Korea

Location

Pfizer Investigational Site

Taipei, 110, Taiwan

Location

Related Publications (3)

• 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. doi: 10.1186/1479-5876-9-120.

  PMID: 21787417 DERIVED

• 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. doi: 10.1158/1078-0432.CCR-10-1708. Epub 2011 Apr 29.

  PMID: 21531821 DERIVED

• Faivre S, Raymond E, Boucher E, Douillard J, Lim HY, Kim JS, Zappa M, Lanzalone S, Lin X, Deprimo S, Harmon C, Ruiz-Garcia A, Lechuga MJ, Cheng AL. Safety and efficacy of sunitinib in patients with advanced hepatocellular carcinoma: an open-label, multicentre, phase II study. Lancet Oncol. 2009 Aug;10(8):794-800. doi: 10.1016/S1470-2045(09)70171-8. Epub 2009 Jul 6.

  PMID: 19586800 DERIVED

Related Links

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

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 1, 2005
• First Posted: November 2, 2005
• Study Start: February 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2009
• Last Updated: February 18, 2010
• Results First Posted: February 2, 2010

Record last verified: 2010-02

Locations

TW (1); KR (4); FR (3)