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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00334282




Registration number
NCT00334282
Ethics application status
Date submitted
5/06/2006
Date registered
7/06/2006
Date last updated
5/02/2016

Titles & IDs
Public title
Safety and Efficacy of GW786034 (Pazopanib) In Metastatic Renal Cell Carcinoma
Scientific title
A Randomised, Double-blind, Placebo Controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) Compared to Placebo in Patients With Locally Advanced and/or Metastatic Renal Cell Carcinoma
Secondary ID [1] 0 0
VEG105192
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Renal Cell 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pazopanib
Treatment: Drugs - placebo

Placebo Comparator: placebo arm - matching placebo (800 mg tablet) once daily

Experimental: pazopanib arm - Oral pazopanib tablet 800 mg once daily continuously


Treatment: Drugs: Pazopanib
Oral pazopanib tablet 800 mg once daily continuously

Treatment: Drugs: placebo
matching placebo (800 mg tablet) once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival
Timepoint [1] 0 0
Randomization until progression (up to 2 years)
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Randomization until death (up to 2 years)
Secondary outcome [2] 0 0
Overall Response
Timepoint [2] 0 0
Baseline until either response or progression (up to 2 years)
Secondary outcome [3] 0 0
Participants With Complete Response, Partial Response, or 6 Months of Stable Disease
Timepoint [3] 0 0
Baseline until 6 months post-Baseline or progressive disease
Secondary outcome [4] 0 0
Duration of Response
Timepoint [4] 0 0
Time from response until progression (up to 2 years)
Secondary outcome [5] 0 0
Time to Response as Assessed by an Independent Review Committee (IRC) and the Investigator
Timepoint [5] 0 0
Randomization until CR or PR (assessed for up to 2 years)
Secondary outcome [6] 0 0
Adjusted Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ C-30) Score at Weeks 6, 12, 18, 24, and 48
Timepoint [6] 0 0
Baseline and Weeks 6, 12, 18, 24, and 48
Secondary outcome [7] 0 0
Adjusted Mean Change From Baseline in the Index Score of the EQ-5D (EuroQoL [Quality of Life]-5D) Questionnaire at Weeks 6, 12, 18, 24, and 48
Timepoint [7] 0 0
Baseline and Weeks 6, 12, 18, 24, and 48
Secondary outcome [8] 0 0
Adjusted Mean Change From Baseline in the Visual Analog Scale (VAS) Score of the EQ-5D (EuroQoL [Quality of Life]-5D) Questionnaire at Weeks 6, 12, 18, 24, and 48
Timepoint [8] 0 0
Baseline and Weeks 6, 12, 18, 24, and 48
Secondary outcome [9] 0 0
Plasma Pazopanib Concentrations Before Dosing and at 2, 4, and 8 Hours After Dosing on Day 1 and Week 3
Timepoint [9] 0 0
Day 1 and Week 3
Secondary outcome [10] 0 0
Baseline Expression Levels of the Indicated Target Proteins in Pazopanib- and Placebo-treated Participants
Timepoint [10] 0 0
Baseline

Eligibility
Key inclusion criteria
A patient will be considered for inclusion in this study only if all of the following
criteria apply:

- Signed written informed consent.

- Diagnosis of clear cell RCC that is predominantly clear cell histology. Note: cytology
cannot be the only pathologic criteria to confirm clear cell RCC. Patients with tumor
types that are interpreted as non-clear cell, e.g. papillary, are excluded.

- Locally advanced RCC (defined as disease not amenable to curative surgery or radiation
therapy) or metastatic RCC (equivalent to Stage IV RCC according to American Joint
Committee on Cancer (AJCC) staging.

- Note: If the metastatic disease is restricted to a solitary lesion, its neoplastic
nature must be confirmed by histology or cytology. Cytology cannot be the only
pathologic criteria to confirm clear cell RCC, but can be used in a patient with
histologically confirmed clear cell RCC to confirm that metastatic disease is
neoplastic in nature.

- Must have measurable disease, i.e. presenting with at least one measurable lesion per
Response Evaluation Criteria in Solid Tumors (RECIST). A measurable lesion is defined
as a lesion that can be accurately measured in at least one dimension with the longest
diameter = 20 mm using conventional techniques, or = 10 mm with spiral CT scan.

- Note: Patient should be excluded if all baseline measurable lesions are within
previously irradiated areas.

- Note: A patient must complete all the baseline disease assessments in order to be
eligible. Baseline head, chest, abdominal and pelvic CT or MRI scans must be performed
within 2 weeks prior to the first dose of study medication; baseline bone scan must be
performed within 3 weeks of the first dose of study medication.

- Patients who have received only one prior systemic treatment for locally advanced or
metastatic RCC with documented disease progression or documented treatment
discontinuation due to unacceptable toxicity. This first-line systemic treatment must
be cytokine based.

- Note: The first-line cytokine-based treatment can be interleukin-2 (IL-2) or
interferon-a (INFa) monotherapy, IL-2 in combination with INF-a, IL-2 and/or INF-a in
combination with chemotherapy, hormonal or other therapies excluding agents targeting
angiogenesis pathways. Agents in a combination regimen can be given sequentially if
the treatment sequence is pre-determined and the patient does not fail one agent prior
to starting another.

- Note: Prior adjuvant or neo-adjuvant therapies are permitted excluding any agents that
target vascular endothelial growth factor (VEGF) or VEGF receptors. The
adjuvant/neo-adjuvant therapies should not be considered as first-line systemic
treatment for advanced RCC.

Or,

- Patients who have received no prior systemic therapy for advanced/metastatic RCC can
be enrolled if under any of the following circumstances:

- Patients who live in countries or regions where there is no established standard
first-line therapy for advanced/metastatic RCC or where there are barriers to the
access of established therapies such as sunitinib, sorafenib, IFNa or IL-2.

- Patients who live in countries or regions where IL-2 or INF-a has been approved for
the treatment of advanced/metastatic RCC, however, these agents are generally not
recognized by the local clinical community as a standard treatment for
advanced/metastatic RCC, or where the physician and the patient have determined that
the available cytokine therapies are not an acceptable therapeutic option.

- Patients who have recurred following prior adjuvant or neo-adjuvant cytokine therapy
for RCC are eligible to participate without receiving a first-line systemic treatment
for locally advanced or metastatic RCC. These patients should be stratified as the
first-line population.

- Male or female = 18 years of age.

- A woman is eligible to participate in the study if she is of:

- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant),
including any female who:

- Has had a hysterectomy,

- Has had a bilateral oophorectomy (ovariectomy),

- Has had a bilateral tubal ligation,

- Is post-menopausal (total cessation of menses for =1 year).

- Childbearing potential, has a negative serum pregnancy test within 2 weeks of the
first dose of study medication, and agrees to use adequate contraception. GSK
acceptable contraceptive methods, when used consistently and in accordance with both
the product label and the instructions of the physician, are as follows:

- An intrauterine device with a documented failure rate of less than 1% per year.

- Vasectomized partner who is sterile prior to the female patient's entry and is the
sole sexual partner for that female.

- Complete abstinence from sexual intercourse for 14 days before exposure to
investigation product, through the clinical trial, and for at least 21 days after the
last dose of investigational product.

- Double-barrier contraception (condom with spermicidal jelly, foam suppository, or
film; diaphragm with spermicide; or male condom and diaphragm with spermicide).

- Oral contraceptives are not reliable due to the potential for drug-drug interactions.

- A man with a female partner of childbearing potential is eligible to enter and
participate in the study if he is abstinent or uses a barrier method of contraception
during the study.

- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1

- Adequate baseline organ function defined as:

- Hematologic function:

Absolute Neutrophil Count (ANC) =1 x 10^9/L Hemoglobin = 9 g/dL Platelet =75 x 10^9/L

- Hepatic function:

Total bilirubin = 1.5 x Upper Limit of Normal (ULN) Aspartate Aminotransferase (AST) and
Alanine Aminotransferase (ALT) = 2 x ULN

- Renal function:

Calculated creatinine clearance=30 mL/min [See Section 14.6 Appendix 6] and

=Urine protein is 0, trace, or +1 determined by dipstick urinalysis, or < 1.0 gram
determined by 24-hour urine protein analysis.

- Note: A patient should first be screened with dipstick urinalysis. If urine protein is
=2+, then a 24-hour urine protein must be assessed and patient will be excluded if
24-hour urine protein is= 1.0 gram.

- Corrected serum calcium level within normal range per local clinical laboratory
standard.

Note: Patients with hypercalcemia should be treated until the corrected serum calcium level
reaches the normal range.

- At least 4 weeks must have elapsed since the last surgery and 2 weeks must have
elapsed since radiotherapy or the last systemic cytokine therapy.

- Complete recovery from prior surgery, and/or reduction of all AEs to Grade 1 from
prior systemic therapy or radiotherapy.

- Note: In patients with prior radiotherapy, the steroid doses should be stable or
decreasing for at least 2 weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A patient will not be eligible for inclusion in this study if any of the following criteria
apply:

- Pregnant or lactating female.

- History of another malignancy.

- Note: Patients who have had another malignancy and have been disease-free for 5 years,
or patients with a history of completely resected non-melanomatous skin carcinoma or
successfully treated in situ carcinoma are eligible.

- History or presence of central nervous system (CNS) metastasis or leptomeningeal
tumors as documented by CT or MRI scan, analysis of cerebrospinal fluid or
neurological exam.

Note: A baseline brain CT or MRI scan must be obtained in all patients within 2 weeks of
the first dose of study medication.

- Malabsorption syndrome or disease that significantly affects gastrointestinal
function, or major resection of the stomach or small bowel that could affect the
absorption of pazopanib.

- Unable to swallow and retain orally administered medication.

- Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other
gastrointestinal conditions with increased risk of perforation; history of abdominal
fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior
to beginning study treatment.

- History of human immunodeficiency virus infection.

- Presence of uncontrolled infection.

- Corrected QT interval (QTc) prolongation defined as QTc interval > 470 msecs.

- History of Class III or IV congestive heart failure according to New York Heart
Association (NYHA) classification.

- History of any one of the following cardiac conditions within the past 6 months:

- Cardiac angioplasty or stenting, or

- Myocardial infarction, or

- Unstable angina.

- History of cerebrovascular accident within the past 6 months.

- Poorly controlled hypertension [defined as systolic blood pressure (SBP) of =140mmHg,
or diastolic blood pressure (DBP) of = 90mmHg].

- Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to
study entry. The blood pressure must be re-assessed on two occasions that are
separated by a minimum of 24 hours. The mean SBP / DBP values from both blood pressure
assessments must be < 140/90mmHg in order for a patient to be eligible for the study.

- History of untreated deep venous thrombosis (DVT) within the past 6 months (e.g. a
calf vein thrombosis that is not treated).

Note: Patients with recent DVT who are treated with therapeutic anti-coagulating agents
(excluding therapeutic warfarin) for at least 2 weeks are eligible.

- Presence of any non-healing wound, fracture, or ulcer, or presence of symptomatic
peripheral vascular disease.

- Evidence of bleeding diathesis or coagulopathy.

- Any serious and/or unstable pre-existing medical, psychiatric, or other conditions
that could interfere with patient's safety, obtaining informed consent or compliance
to the study.

- Has taken any prohibited medications within 14 days of the first dose of study
medication.

- Current or prior use of an investigational anti-cancer drug within 4 weeks of start of
study.

- Prior use of an investigational or licensed drug that targets VEGF or VEGF receptors
(eg. bevacizumab, sunitinib, sorafenib, etc).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
435
Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - St Leonards
Recruitment hospital [2] 0 0
GSK Investigational Site - Waratah
Recruitment hospital [3] 0 0
GSK Investigational Site - Hobart
Recruitment hospital [4] 0 0
GSK Investigational Site - Heidelberg
Recruitment hospital [5] 0 0
GSK Investigational Site - Wodonga
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
7000 - Hobart
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3690 - Wodonga
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Córdova
Country [3] 0 0
Argentina
State/province [3] 0 0
Santa Fe
Country [4] 0 0
Argentina
State/province [4] 0 0
Quilmes
Country [5] 0 0
Argentina
State/province [5] 0 0
Tucuman
Country [6] 0 0
Austria
State/province [6] 0 0
Salzburg
Country [7] 0 0
Austria
State/province [7] 0 0
Vienna
Country [8] 0 0
Brazil
State/province [8] 0 0
Minas Gerais
Country [9] 0 0
Brazil
State/province [9] 0 0
Rio Grande Do Sul
Country [10] 0 0
Brazil
State/province [10] 0 0
São Paulo
Country [11] 0 0
Chile
State/province [11] 0 0
Región Metro De Santiago
Country [12] 0 0
Chile
State/province [12] 0 0
Valparaíso
Country [13] 0 0
China
State/province [13] 0 0
Beijing
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Brno
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Chomutov
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Ostrava - Poruba
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Praha 2
Country [18] 0 0
Estonia
State/province [18] 0 0
Tallinn
Country [19] 0 0
Estonia
State/province [19] 0 0
Tartu
Country [20] 0 0
Greece
State/province [20] 0 0
Athens
Country [21] 0 0
Greece
State/province [21] 0 0
Patra
Country [22] 0 0
Greece
State/province [22] 0 0
Thessaloniki
Country [23] 0 0
Hong Kong
State/province [23] 0 0
Hong Kong
Country [24] 0 0
Hong Kong
State/province [24] 0 0
Kowloon
Country [25] 0 0
Hong Kong
State/province [25] 0 0
Tuen Mun, New Territories
Country [26] 0 0
India
State/province [26] 0 0
Bangalore
Country [27] 0 0
India
State/province [27] 0 0
Hyderabad
Country [28] 0 0
India
State/province [28] 0 0
Mumbai
Country [29] 0 0
India
State/province [29] 0 0
Pune
Country [30] 0 0
India
State/province [30] 0 0
Trivandrum
Country [31] 0 0
Ireland
State/province [31] 0 0
Galway
Country [32] 0 0
Ireland
State/province [32] 0 0
Tallaght, Dublin
Country [33] 0 0
Italy
State/province [33] 0 0
Lazio
Country [34] 0 0
Italy
State/province [34] 0 0
Lombardia
Country [35] 0 0
Italy
State/province [35] 0 0
Piemonte
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Seoul
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
songpa-gu, Seoul
Country [38] 0 0
Latvia
State/province [38] 0 0
Riga
Country [39] 0 0
Lithuania
State/province [39] 0 0
Kaunas
Country [40] 0 0
Lithuania
State/province [40] 0 0
Klaipeda
Country [41] 0 0
Lithuania
State/province [41] 0 0
Vilnius
Country [42] 0 0
Mexico
State/province [42] 0 0
Jalisco
Country [43] 0 0
Mexico
State/province [43] 0 0
Yucatán
Country [44] 0 0
Mexico
State/province [44] 0 0
Mexico City
Country [45] 0 0
New Zealand
State/province [45] 0 0
Christchurch
Country [46] 0 0
New Zealand
State/province [46] 0 0
Newtown, Wellington
Country [47] 0 0
New Zealand
State/province [47] 0 0
Palmerston North
Country [48] 0 0
Pakistan
State/province [48] 0 0
Islamabad
Country [49] 0 0
Pakistan
State/province [49] 0 0
Karachi
Country [50] 0 0
Pakistan
State/province [50] 0 0
Lahore
Country [51] 0 0
Poland
State/province [51] 0 0
Gdansk
Country [52] 0 0
Poland
State/province [52] 0 0
Krakow
Country [53] 0 0
Poland
State/province [53] 0 0
Kraków
Country [54] 0 0
Poland
State/province [54] 0 0
Olsztyn
Country [55] 0 0
Poland
State/province [55] 0 0
Poznan
Country [56] 0 0
Poland
State/province [56] 0 0
Warszawa
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Chelyabinsk
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Kazan
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Moscow
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Omsk
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Samara
Country [62] 0 0
Russian Federation
State/province [62] 0 0
St. Petersburg
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Voronezh
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Yaroslavl
Country [65] 0 0
Slovakia
State/province [65] 0 0
Bratislava
Country [66] 0 0
Tunisia
State/province [66] 0 0
Sfax
Country [67] 0 0
Tunisia
State/province [67] 0 0
Sousse
Country [68] 0 0
Tunisia
State/province [68] 0 0
Tunis
Country [69] 0 0
Ukraine
State/province [69] 0 0
Donetsk
Country [70] 0 0
Ukraine
State/province [70] 0 0
Kharkiv
Country [71] 0 0
Ukraine
State/province [71] 0 0
Kyiv
Country [72] 0 0
Ukraine
State/province [72] 0 0
Lviv
Country [73] 0 0
Ukraine
State/province [73] 0 0
Zaporizhzhya
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Devon
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Lancashire
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Bebington, Wirral
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Belfast
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To evaluate efficacy and safety of pazopanib compared to placebo in patients with locally
advanced and/ or metastatic renal cell carcinoma (RCC). Approximately 350-400 eligible
patients will be stratified and randomized in a 2:1 ratio to receive either 800 mg pazopanib
once daily or matching placebo. The study treatment will continue until patients experience
disease progression, unacceptable toxicity or death. Primary objective of the study is to
evaluate and compare the two treatment arms for progression-free survival. Principal
secondary objective is to evaluate and compare the two treatment arms with respect to overall
survival. Other objectives are overall response rate [complete response (CR) + partial
response (PR)], rate of CR + PR + 6 months stable disease, and the incidence, severity and
causality of adverse events and serious adverse events. Safety and efficacy assessments will
be regularly performed on all patients. An Independent Data Monitoring Committee will be
established to monitor safety during the course of the study and to evaluate interim efficacy
data on overall survival.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00334282
Trial related presentations / publications
Bonate PL, Suttle AB. Modeling tumor growth kinetics after treatment with pazopanib or placebo in patients with renal cell carcinoma. Cancer Chemother Pharmacol. 2013 Jul;72(1):231-40. doi: 10.1007/s00280-013-2191-0. Epub 2013 May 29.
Tran HT, Liu Y, Zurita AJ, Lin Y, Baker-Neblett KL, Martin AM, Figlin RA, Hutson TE, Sternberg CN, Amado RG, Pandite LN, Heymach JV. Prognostic or predictive plasma cytokines and angiogenic factors for patients treated with pazopanib for metastatic renal-cell cancer: a retrospective analysis of phase 2 and phase 3 trials. Lancet Oncol. 2012 Aug;13(8):827-37. doi: 10.1016/S1470-2045(12)70241-3. Epub 2012 Jul 2.
Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J, Barrios CH, Salman P, Gladkov OA, Kavina A, Zarba JJ, Chen M, McCann L, Pandite L, Roychowdhury DF, Hawkins RE. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol. 2010 Feb 20;28(6):1061-8. doi: 10.1200/JCO.2009.23.9764. Epub 2010 Jan 25.
Maitland ML, Wu K, Sharma MR, Jin Y, Kang SP, Stadler WM, Karrison TG, Ratain MJ, Bies RR. Estimation of renal cell carcinoma treatment effects from disease progression modeling. Clin Pharmacol Ther. 2013 Apr;93(4):345-51. doi: 10.1038/clpt.2012.263. Epub 2012 Dec 27.
Xu CF, Reck BH, Goodman VL, Xue Z, Huang L, Barnes MR, Koshy B, Spraggs CF, Mooser VE, Cardon LR, Pandite LN. Association of the hemochromatosis gene with pazopanib-induced transaminase elevation in renal cell carcinoma. J Hepatol. 2011 Jun;54(6):1237-43. doi: 10.1016/j.jhep.2010.09.028. Epub 2011 Feb 12.
Xu CF, Reck BH, Xue Z, Huang L, Baker KL, Chen M, Chen EP, Ellens HE, Mooser VE, Cardon LR, Spraggs CF, Pandite L. Pazopanib-induced hyperbilirubinemia is associated with Gilbert's syndrome UGT1A1 polymorphism. Br J Cancer. 2010 Apr 27;102(9):1371-7. doi: 10.1038/sj.bjc.6605653. Epub 2010 Apr 13.
Sternberg CN, Hawkins RE, Wagstaff J, Salman P, Mardiak J, Barrios CH, Zarba JJ, Gladkov OA, Lee E, Szczylik C, McCann L, Rubin SD, Chen M, Davis ID. A randomised, double-blind phase III study of pazopanib in patients with advanced and/or metastatic renal cell carcinoma: final overall survival results and safety update. Eur J Cancer. 2013 Apr;49(6):1287-96. doi: 10.1016/j.ejca.2012.12.010. Epub 2013 Jan 12.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00334282