Back to resultsAn International Phase 2 Study Of SU011248 In Patients With Inoperable Liver Cancer
Primary Purpose
Liver Neoplasms, Unresectable Hepatocellular Carcinoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Sunitinib (SU011248)
Sponsored by
About this trial
This is an interventional treatment trial for Liver Neoplasms focused on measuring Liver neoplasms, sunitinib, Phase 2
Eligibility 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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Duration of Objective Response (CR or PR)
Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of disease progression or to death due to any cause. CR=disappearance of all target lesions. PR= ≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions.
Clinical Benefit Response (CR, PR, or SD With Duration ≥12 Weeks)
Number of patients with Clinical Benefit Response: confirmed CR, confirmed PR, or SD for at least 12 weeks on study according to RECIST. CR=disappearance of all target lesions. PR= ≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. SD=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.
Best Overall Response of PR or SD With Duration ≥12 Weeks
Number of patients with best overall response of PR or SD with duration ≥ 12 weeks. Best overall response was defined as the time from the first documentation of tumor response that was subsequently confirmed to the first documentation of disease progression or to death due to any cause. CR=disappearance of all target lesions. PR= ≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. SD=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.
Progression-Free Survival (Overall ITT)
Time from start of study treatment to first documentation of objective tumor progression, or to death due to any cause.
Progression-Free Survival (ITT Child Pugh Class A Subject Population)
Time from start of study treatment to first documentation of objective tumor progression, or to death due to any cause.
Time to Tumor Progression (Overall ITT)
Time from the start of study treatment to the first documentation of objective tumor progression.
Time to Tumor Progression (ITT Child Pugh Class A Subject Population)
Time from the start of study treatment to the first documentation of objective tumor progression.
Overall Survival (Overall ITT)
Time from the date of first dose of study medication to the date of death due to any cause.
Overall Survival (ITT Child Pugh Class A Subject Population)
Time from the date of first dose of study medication to the date of death due to any cause.
1-Year Survival Probability
Probability of survival 1 year after the first dose of study treatment.
Trough Plasma Concentrations (Ctrough) of Sunitinib
Ctrough = the concentration prior to study drug administration.
Ctrough of SU-012662 (Metabolite of Sunitinib)
Ctrough = the concentration prior to study drug administration.
Ctrough of Total Drug (Sunitinib + SU-012662)
Ctrough = the concentration prior to study drug administration.
Dose-Corrected Ctrough of Sunitinib
Data was dose-corrected to the starting dose (dose-corrected Ctrough = observed Ctrough x [starting dose/actual dose]).
Dose-Corrected Ctrough of SU-012662 (Metabolite of Sunitinib)
Data was dose-corrected to the starting dose (dose-corrected Ctrough = observed Ctrough x [starting dose/actual dose]).
Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662)
Data was dose-corrected to the starting dose (dose-corrected Ctrough = observed Ctrough x [starting dose/actual dose]).
Circulating Endothelial Cells (CECs) and Circulating Endothelial Progenitor Cells (CEPs)
Blood samples for the assessment of CECs and circulating CEPs were planned to be obtained for subjects in Part 1 of the study, and for a subset of subjects in Part 2 of the study to complete the angiogenic profile of unresectable hepatocellular carcinoma, in addition to the soluble protein evaluation.
Tissue Tumor Markers Assessed by Tumor Biopsy
Provision of previously collected tumor paraffin blocks (or at least 5-10 4-micron slides prepared from the paraffin block) for correlative laboratory analysis was optional. For all subjects showing OR on study, it was highly recommended to provide previously collected paraffin blocks (or at least 5-10 4-micron slides prepared from the paraffin block). These samples were to be analyzed for markers that may be associated with tumor proliferation or angiogenesis.
Plasma Concentration of Vascular Endothelial Growth Factor (VEGF)
Plasma concentrations of VEGF that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by e nzyme-linked immunosorbent assay (ELISA). Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.
Plasma Concentration of VEGF-C
Plasma concentrations of VEGF-C that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by ELISA. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.
Plasma Concentration of Soluble VEGF Receptor-2 (sVEGFR-2)
Plasma concentrations of sVEGFR-2 that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by ELISA. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline). Samples below the limit of quantitation and samples with insufficient volume available were excluded.
Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3)
Plasma concentrations of sVEGFR-3 that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by ELISA. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.
Plasma Concentration of Soluble KIT (sKIT)
Plasma concentrations of sKIT that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by ELISA analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00247676
Brief Title
An International Phase 2 Study Of SU011248 In Patients With Inoperable Liver Cancer
Official Title
An Open Label International Multi-Center Phase 2 Activity And Safety Study Of SU011248 In Patients With Unresectable Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Neoplasms, Unresectable Hepatocellular Carcinoma
Keywords
Liver neoplasms, sunitinib, Phase 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sunitinib (SU011248)
Other Intervention Name(s)
SU011248, Sutent
Intervention Description
Sunitinib 50 mg by oral capsule, daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.
Primary Outcome Measure Information:
Title
Best Overall Response
Description
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.
Time Frame
From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter
Title
Objective Response (CR or PR)
Description
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.
Time Frame
From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter
Secondary Outcome Measure Information:
Title
Duration of Objective Response (CR or PR)
Description
Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of disease progression or to death due to any cause. CR=disappearance of all target lesions. PR= ≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions.
Time Frame
From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death due to cancer
Title
Clinical Benefit Response (CR, PR, or SD With Duration ≥12 Weeks)
Description
Number of patients with Clinical Benefit Response: confirmed CR, confirmed PR, or SD for at least 12 weeks on study according to RECIST. CR=disappearance of all target lesions. PR= ≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. SD=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.
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
Title
Best Overall Response of PR or SD With Duration ≥12 Weeks
Description
Number of patients with best overall response of PR or SD with duration ≥ 12 weeks. Best overall response was defined as the time from the first documentation of tumor response that was subsequently confirmed to the first documentation of disease progression or to death due to any cause. CR=disappearance of all target lesions. PR= ≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. SD=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.
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
Title
Progression-Free Survival (Overall ITT)
Description
Time from start of study treatment to first documentation of objective tumor progression, or to death due to any cause.
Time Frame
From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death
Title
Progression-Free Survival (ITT Child Pugh Class A Subject Population)
Description
Time from start of study treatment to first documentation of objective tumor progression, or to death due to any cause.
Time Frame
From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death
Title
Time to Tumor Progression (Overall ITT)
Description
Time from the start of study treatment to the first documentation of objective tumor progression.
Time Frame
From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter
Title
Time to Tumor Progression (ITT Child Pugh Class A Subject Population)
Description
Time from the start of study treatment to the first documentation of objective tumor progression.
Time Frame
From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter
Title
Overall Survival (Overall ITT)
Description
Time from the date of first dose of study medication to the date of death due to any cause.
Time Frame
From start of study treatment until death.
Title
Overall Survival (ITT Child Pugh Class A Subject Population)
Description
Time from the date of first dose of study medication to the date of death due to any cause.
Time Frame
From start of study treatment until death.
Title
1-Year Survival Probability
Description
Probability of survival 1 year after the first dose of study treatment.
Time Frame
From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter up until 1 year.
Title
Trough Plasma Concentrations (Ctrough) of Sunitinib
Description
Ctrough = the concentration prior to study drug administration.
Time Frame
Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)
Title
Ctrough of SU-012662 (Metabolite of Sunitinib)
Description
Ctrough = the concentration prior to study drug administration.
Time Frame
Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)
Title
Ctrough of Total Drug (Sunitinib + SU-012662)
Description
Ctrough = the concentration prior to study drug administration.
Time Frame
Cycle 1 (Days 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)
Title
Dose-Corrected Ctrough of Sunitinib
Description
Data was dose-corrected to the starting dose (dose-corrected Ctrough = observed Ctrough x [starting dose/actual dose]).
Time Frame
Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)
Title
Dose-Corrected Ctrough of SU-012662 (Metabolite of Sunitinib)
Description
Data was dose-corrected to the starting dose (dose-corrected Ctrough = observed Ctrough x [starting dose/actual dose]).
Time Frame
Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)
Title
Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662)
Description
Data was dose-corrected to the starting dose (dose-corrected Ctrough = observed Ctrough x [starting dose/actual dose]).
Time Frame
Cycle 1 (Days 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)
Title
Circulating Endothelial Cells (CECs) and Circulating Endothelial Progenitor Cells (CEPs)
Description
Blood samples for the assessment of CECs and circulating CEPs were planned to be obtained for subjects in Part 1 of the study, and for a subset of subjects in Part 2 of the study to complete the angiogenic profile of unresectable hepatocellular carcinoma, in addition to the soluble protein evaluation.
Time Frame
Cycle 1 (Days 1, 14), Cycle 2 (Days 1, 28), Cycle 5 (Day 1)
Title
Tissue Tumor Markers Assessed by Tumor Biopsy
Description
Provision of previously collected tumor paraffin blocks (or at least 5-10 4-micron slides prepared from the paraffin block) for correlative laboratory analysis was optional. For all subjects showing OR on study, it was highly recommended to provide previously collected paraffin blocks (or at least 5-10 4-micron slides prepared from the paraffin block). These samples were to be analyzed for markers that may be associated with tumor proliferation or angiogenesis.
Time Frame
Day 28 of Cycle 1 (optional)
Title
Plasma Concentration of Vascular Endothelial Growth Factor (VEGF)
Description
Plasma concentrations of VEGF that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by e nzyme-linked immunosorbent assay (ELISA). Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.
Time Frame
Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)
Title
Plasma Concentration of VEGF-C
Description
Plasma concentrations of VEGF-C that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by ELISA. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.
Time Frame
Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)
Title
Plasma Concentration of Soluble VEGF Receptor-2 (sVEGFR-2)
Description
Plasma concentrations of sVEGFR-2 that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by ELISA. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline). Samples below the limit of quantitation and samples with insufficient volume available were excluded.
Time Frame
Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)
Title
Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3)
Description
Plasma concentrations of sVEGFR-3 that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by ELISA. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.
Time Frame
Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)
Title
Plasma Concentration of Soluble KIT (sKIT)
Description
Plasma concentrations of sKIT that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by ELISA analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.
Time Frame
Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Clichy Cedex
ZIP/Postal Code
92118
Country
France
Facility Name
Pfizer Investigational Site
City
Rennes Cedex
ZIP/Postal Code
4422935062
Country
France
Facility Name
Pfizer Investigational Site
City
Saint Herrblain Cedex
ZIP/Postal Code
44805
Country
France
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
21787417
Citation
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.
Results Reference
derived
PubMed Identifier
21531821
Citation
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.
Results Reference
derived
PubMed Identifier
19586800
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181055&StudyName=An%20International%20Phase%202%20Study%20Of%20SU011248%20In%20Patients%20With%20Inoperable%20Liver%20Cancer
Description
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An International Phase 2 Study Of SU011248 In Patients With Inoperable Liver Cancer
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