Liver NeoplasmsPhase 2NCT00247676
An International Phase 2 Study Of SU011248 In Patients With Inoperable Liver Cancer
A Phase 2 study testing Sunitinib (SU011248) in people with Liver Neoplasms and Unresectable Hepatocellular Carcinoma, run by Pfizer at 8 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Neoplasms, Unresectable Hepatocellular Carcinoma
- What is being tested?
- Sunitinib (SU011248)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Feb 2006to Feb 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 9Show fewer
- Serious acute or chronic illness
- Current treatment on another clinical trial
- Pregnant or breastfeeding
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
South Korea4 sites
Pfizer Investigational Site
Seoul, 110-744
Pfizer Investigational Site
Seoul, 135-710
Pfizer Investigational Site
Seoul, 138-736
Pfizer Investigational Site
Seoul, 152-703
France3 sites
Pfizer Investigational Site
Clichy, 92118
Pfizer Investigational Site
Rennes, 4422935062
Pfizer Investigational Site
Saint Herrblain Cedex, 44805
About this study
Official title: An Open Label International Multi-Center Phase 2 Activity And Safety Study Of SU011248 In Patients With Unresectable Hepatocellular Carcinoma
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
- Being tested
- Sunitinib (SU011248)
- Keywords
- Liver neoplasms, sunitinib, Phase 2
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunitinib (SU011248)Drug
Also called SU011248, Sutent
Sunitinib 50 mg by oral capsule, daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Sunitinib (SU011248) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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)
Time from start of study treatment to first documentation of objective tumor progression, or to death due to any cause.
Measured: 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)
Time from start of study treatment to first documentation of objective tumor progression, or to death due to any cause.
Measured: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death
Time to Tumor Progression (Overall ITT)
Time from the start of study treatment to the first documentation of objective tumor progression.
Measured: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter
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.
Measured: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter
Overall Survival (Overall ITT)
Time from the date of first dose of study medication to the date of death due to any cause.
Measured: From start of study treatment until death.
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.
Measured: From start of study treatment until death.
1-Year Survival Probability
Probability of survival 1 year after the first dose of study treatment.
Measured: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter up until 1 year.
Trough Plasma Concentrations (Ctrough) of Sunitinib
Ctrough = the concentration prior to study drug administration.
Measured: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)
Ctrough of SU-012662 (Metabolite of Sunitinib)
Ctrough = the concentration prior to study drug administration.
Measured: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)
Ctrough of Total Drug (Sunitinib + SU-012662)
Ctrough = the concentration prior to study drug administration.
Measured: Cycle 1 (Days 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)
Dose-Corrected Ctrough of Sunitinib
Data was dose-corrected to the starting dose (dose-corrected Ctrough = observed Ctrough x [starting dose/actual dose]).
Measured: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)
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]).
Measured: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)
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]).
Measured: Cycle 1 (Days 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)
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.
Measured: Cycle 1 (Days 1, 14), Cycle 2 (Days 1, 28), Cycle 5 (Day 1)
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.
Measured: Day 28 of Cycle 1 (optional)
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.
Measured: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)
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.
Measured: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)
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.
Measured: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)
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.
Measured: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)
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.
Measured: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2005 (estimated)
- Study startFeb 2006
- Primary completionFeb 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247676
- Sponsor's protocol ID
- A6181055
- Status last verified
- Feb 2010
- First submitted
- 1 Nov 2005
- Last updated
- 18 Feb 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 21787417Faivre 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.
PubMed 21531821Faivre 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.
PubMed 19586800
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label International Multi-Center Phase 2 Activity And Safety Study Of SU011248 In Patients With Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00247676
- Acronym / sponsor ID
- A6181055
- Keywords
- Liver neoplasms, sunitinib, Phase 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 2 Nov 2005 (estimated)
- Results
- Posted 2 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Sunitinib (SU011248) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sunitinib (SU011248)Also: SU011248, SutentSunitinib 50 mg by oral capsule, daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity. | Drug | A |
Primary outcome
Best Overall Response
Time frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter
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)
Time frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter
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.
23 secondary outcomes
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
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
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
Progression-Free Survival (Overall ITT)
Time frame: 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)
Time frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death
Time to Tumor Progression (Overall ITT)
Time frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter
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
Overall Survival (Overall ITT)
Time frame: From start of study treatment until death.
Overall Survival (ITT Child Pugh Class A Subject Population)
Time frame: From start of study treatment until death.
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.
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)
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)
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)
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)
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)
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)
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)
Tissue Tumor Markers Assessed by Tumor Biopsy
Time frame: Day 28 of Cycle 1 (optional)
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)
Plasma Concentration of VEGF-C
Time frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)
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)
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)
Plasma Concentration of Soluble KIT (sKIT)
Time frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21787417Harmon 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.
- Derived from this study: PubMed 21531821Faivre 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.
- Derived from this study: PubMed 19586800Faivre 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sunitinib (SU011248) in people with Liver Neoplasms and Unresectable Hepatocellular Carcinoma, run by Pfizer at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea, France, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Overall Response (time frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00247676, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2010.