AzTrials
AzTrials

Neoplasms, BreastPhase 2NCT00558103

Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Inflammatory Breast Cancer

A Phase 2 study testing lapatinib and Pazopanib in people with Neoplasms, Breast, run by GlaxoSmithKline at 126 sites in 28 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The double blind part of the study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone in subjects with inflammatory breast cancer whose tumors overexpress the ErbB2 protein. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Neoplasms, Breast
What is being tested?
lapatinib and Pazopanib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
163 participants
Where
126 sitesin 28 countries
Study dates
Dec 2007to Dec 2011
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact patient eligibility is provided in the pazopanib IB and lapatinib prescribing information (or the lapatinib IB).
  • For Cohort 1 of this study, eligible patients met inclusion criteria outlined in the original version of the protocol and protocol amendment 1.
  • For Cohort 2 of this study, eligible patients must meet all of the following criteria:
  • Patients must have evaluable Inflammatory Breast Cancer (IBC) substantiated by all of the following prior to randomization:
  • History of invasive breast cancer documented by a biopsy and accompanying pathology report
  • Current photographs* (global view and close-up views of all skin lesions) submitted at screening demonstrating unequivocal evidence of IBC as determined by either the medical monitor alone or in consultation with one or more of the study Principal Investigators.
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  • All patients must have photography at screening. Canfield Scientific Inc. will provide centralized monitoring, tracking, and collection of patients' photographs throughout the study. Screening photographs must be uploaded to the Canfield Scientific Inc website and approved by Canfield Scientific Inc, as the central photography vendor. The photographs, along with the completed Inflammatory Breast Cancer Skin Assessment Tool (IBSAT), must be reviewed and approved by GSK before a patient can be randomized. Sites should allow a minimum of 3 business days for this process. Sites submitting quality photographs and IBSATs on a regular basis will receive an exemption from this requirement for future patients.
  • Patients with secondary IBC are eligible.
  • Measurable lesions (cutaneous or radiographic) may be in the field of prior standard or palliative radiation therapy; however, there must be at least a 4 week period between the last radiation treatment and the baseline scan documenting disease status for the lesion to be measurable. If the irradiated lesion is the only site of disease, documented progression of the irradiated lesion is required.
  • Disease progression or relapse following treatment for invasive breast cancer, which must have included a chemotherapy regimen. In regions where trastuzumab is available with no barriers to access*, patients must have received prior trastuzumab in addition to chemotherapy in order to be eligible. * (Barriers to access may include financial considerations.)
  • Unequivocal ErbB2 overexpressing breast cancer, defined as 3+ staining by immunohistochemistry (IHC), or 2+ staining by IHC in conjunction with ErbB2 gene amplification by FISH/CISH, or ErbB2 gene amplification by FISH/CISH alone (in subjects whose tumor blocks were not assessed by IHC). ErbB2 gene amplification is defined by: > six (6) ErbB2 gene copies/nucleus for test systems without an internal control probe or an ErbB2/CEP 17 ratio of more than 2.2.
  • Sites must submit a copy of the laboratory report demonstrating unequivocal ErbB2 overexpression, if testing performed at a local laboratory, with the screening worksheet. Archived tumor must be provided for all patients for ErbB2 FISH testing by the central laboratory. Patients will remain on study based on local ErbB2 expression results. If archived tumor is not available, a biopsy must be obtained at screening and sent to TMD Laboratories for ErbB2 FISH testing.
  • Patients must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up. Procedures conducted as part of the patient's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol.
  • Note: Informed consent may be obtained prior to the protocol-specified screening window (i.e. Day -14 to Day -1).
  • Females age ≥ 18 years, except in Tunisia. In Tunisia, patients must be ≥ 20 years to be eligible for this study.
  • Adequate organ function as defined below:
  • System (Laboratory Values)
  • Hematologic:Absolute neutrophil count (ANC)(≥ 1.5 X 10^9/L)Hemoglobin1(≥9 g/dL)Platelets(≥100 X 10^9/L)International normalized ratio (INR)(≤ 1.2 X upper limit of normal (ULN))Partial thromboplastin time (PTT)(≤1.2 X ULN)
  • Hepatic:Total bilirubin2 (≤ 1.5 X upper limit of normal (ULN))AST and ALT(≤ 2.5 X ULN)
  • Renal:Serum Creatinine (≤ 1.5 mg/dL)Or, if serum creatinine >1.5 mg/dL,
  • Calculated creatinine clearance(≥50 mL/min)
  • Urine Protein to Creatinine Ratio(<1)
  • Patients may not have had a transfusion within 7 days of screening assessment.
  • Exception: Patients with elevated bilirubin levels due to Gilberts syndrome are eligible.
  • Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram. MUGA scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive or where MUGA scans are the accepted standard. Patients with known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure are not eligible.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • A female is eligible to enter and participate in this study if she is of:
  • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:
  • A hysterectomy
  • A bilateral oophorectomy (ovariectomy)
  • A bilateral tubal ligation
  • Is post-menopausal
  • Patients not using hormone replacement therapy (HRT) must have experienced total cessation of menses for ≥ 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value >40 mIU/mL and an estradiol value < 40pg/mL (<140 pmol/L).
  • Patients must discontinue HRT prior to study enrollment due to the potential for inhibition of CYP enzymes that metabolize estrogens and progestins (See Section 8). For most forms of HRT, at least 2-4 weeks must elapse between the cessation of HRT and determination of menopausal status; length of this interval depends on the type and dosage of HRT. If a female patient is determined not to be post-menopausal, they must use adequate contraception, as defined immediately below.
  • Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, has used adequate contraception since the pregnancy test and agrees to use adequate contraception as described below. GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow:
  • 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 investigational product, through the dosing period, 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).
  • Note: Oral contraceptives are not reliable due to potential drug drug interactions.
  • Female patients who are lactating should discontinue nursing prior to the first dose of investigational product and should refrain from nursing throughout the treatment period and for 14 days following the last dose of investigational product.
  • French patients: In France, a patient will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Who cannot join

  • Patients meeting any of the following criteria must not be enrolled in the study:
  • Treatment in the 14 days prior to randomization with any cancer therapy (tumor embolization, chemotherapy, immunotherapy, biological therapy, or hormonal therapy) or treatment with mitomycin within 6 weeks prior to randomization. Such treatment may not be resumed or begun after study entry. Note: Patients receiving LH-RH analogue therapy prior to the study may continue to receive LH-RH analogues for the duration of study participation. Bisphosphonates are permitted if started prior to Day 1.
  • Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity (with the exception of alopecia).
  • Prior lapatinib therapy or other Her2/ErbB2 targeted therapy (except trastuzumab).
  • Prior therapy with an anti-VEGF antibody or other VEGF/VEGF-R targeted therapy.
  • Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product.
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  • Use of any prohibited medication within the timeframes listed in Section 8.1.3
  • History of another malignancy.
  • Note: Subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible. If subject previously had breast cancer, it must have been HER2+ with either 3+ overexpression by IHC or unequivocal HER2 gene amplification by FISH or CISH.
  • History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 2 months prior to first dose of study drug. Screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if clinically indicated or if the subject has a history of CNS metastases.
  • Clinically significant gastrointestinal abnormalities that may increase the risk for GI bleeding including, but not limited to:
  • Active peptic ulcer disease
  • Known intraluminal metastatic lesion/s with suspected bleeding
  • 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 28 days prior to beginning study treatment.
  • Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but limited to:
  • Malabsorption syndrome
  • Major resection of the stomach or small bowel.
  • Presence of uncontrolled infection.
  • Prolongation of corrected QT interval (QTc) > 480 msecs.
  • History of any one or more of the following cardiovascular conditions within the past 6 months:
  • Cardiac angioplasty or stenting
  • Myocardial infarction
  • Unstable angina
  • Arterial thrombosis
  • Symptomatic peripheral vascular disease
  • Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) (see Section 15.9 Appendix 9 for description).
  • 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 during the screening period, in order to control a patient's BP prior to randomization. Blood pressure must be re-assessed on two occasions that are separated by a minimum of 1 hour. The mean SBP / DBP values from each blood pressure assessment must be < 140/90mmHg in order for a patient to be eligible for the study. See Section 6.2 and Section 6.4.2 for details on blood pressure control and reassessment prior to study enrollment.
  • History of cerebrovascular accident, including TIA, pulmonary embolism or deep venous thrombosis (DVT).
  • Prior major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (other than ulcers due to inflammatory breast cancer).
  • Evidence of active bleeding or bleeding diathesis.
  • Hemoptysis within 6 weeks prior to first dose of investigational product.
  • Known endobronchial lesions or involvement of large pulmonary vessels by tumor.
  • Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with patient's safety, provision of informed consent, or compliance to study procedures.
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or lapatinib.
  • Have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).

Trial locations and contacts

126 sites in 28 countries.

126 sites in 28 countries

Germany18 sites

  • GSK Investigational Site

    Aschaffenburg, Bavaria, 63739

  • GSK Investigational Site

    Berlin, State of Berlin, 10367

  • GSK Investigational Site

    Berlin, State of Berlin, 12163

  • GSK Investigational Site

    Duisburg, North Rhine-Westphalia, 47166

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45122

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60596

  • GSK Investigational Site

    Herne, North Rhine-Westphalia, 44623

  • GSK Investigational Site

    Lohsa, Saxony, 02999

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55131

  • GSK Investigational Site

    Mannheim, Baden-Wurttemberg, 68161

  • GSK Investigational Site

    Munich, Bavaria, 80637

  • GSK Investigational Site

    Pinneberg, Schleswig-Holstein, 25421

  • GSK Investigational Site

    Rosenheim, Bavaria, 83022

  • GSK Investigational Site

    Troisdorf, North Rhine-Westphalia, 53840

  • GSK Investigational Site

    Ulm, Baden-Wurttemberg, 89075

  • GSK Investigational Site

    Velbert, North Rhine-Westphalia, 42551

  • GSK Investigational Site

    Witten, North Rhine-Westphalia, 58452

  • GSK Investigational Site

    Zwickau, Saxony, 08060

Other trials in Germany

United States17 sites

  • GSK Investigational Site

    Charleston, South Carolina, 29425

  • GSK Investigational Site

    Chicago, Illinois, 60637

  • GSK Investigational Site

    Denver, Colorado, 80205

  • GSK Investigational Site

    Detroit, Michigan, 48201

  • GSK Investigational Site

    Durham, North Carolina, 27710

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Long Beach, California, 90806

  • GSK Investigational Site

    Memphis, Tennessee, 38138

  • GSK Investigational Site

    Ogden, Utah, 84403

  • GSK Investigational Site

    Omaha, Nebraska, 68114

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19111

  • GSK Investigational Site

    Sacramento, California, 95816

  • GSK Investigational Site

    Scarborough, Maine, 4074

  • GSK Investigational Site

    Seattle, Washington, 98109

  • GSK Investigational Site

    Voorhees Township, New Jersey, 08043

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20010

  • GSK Investigational Site

    Zion, Illinois, 60099

Other trials in United States

France13 sites

  • GSK Investigational Site

    Bayonne, 64100

  • GSK Investigational Site

    Bordeaux, 33076

  • GSK Investigational Site

    Clermont-Ferrand, 63011

  • GSK Investigational Site

    Lille, 59020

  • GSK Investigational Site

    Lyon, 69008

  • GSK Investigational Site

    Marseille Cedex BP 156, 13273

  • GSK Investigational Site

    Mulhouse, 68070

  • GSK Investigational Site

    Paris, 75248

  • GSK Investigational Site

    Paris, 75970

  • GSK Investigational Site

    Saint-Cloud, 92210

  • GSK Investigational Site

    Saint-Herblain, 44805

  • GSK Investigational Site

    Tours, 37044

  • GSK Investigational Site

    Valenciennes, 59322

Other trials in France

Spain9 sites

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Madrid, 28033

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    Seville, 41013

  • GSK Investigational Site

    Valencia, 46009

  • GSK Investigational Site

    Valencia, 46010

Other trials in Spain

Russia6 sites

  • GSK Investigational Site

    Chelyabinsk, 454087

  • GSK Investigational Site

    Kazan', 420111

  • GSK Investigational Site

    Moscow, 115478

  • GSK Investigational Site

    Ryazan, 390011

  • GSK Investigational Site

    Saint Petersburg, 197022

  • GSK Investigational Site

    Saint Petersburg, 197758

Other trials in Russia

Belgium4 sites

  • GSK Investigational Site

    Brussels, 1000

  • GSK Investigational Site

    Edegem, 2650

  • GSK Investigational Site

    Jette, 1090

  • GSK Investigational Site

    Wilrijk, 2610

Other trials in Belgium

China4 sites

  • GSK Investigational Site

    Beijing, 100021

  • GSK Investigational Site

    Beijing, 100071

  • GSK Investigational Site

    Shanghai, 200032

  • GSK Investigational Site

    Tianjin, 300060

Other trials in China

Israel4 sites

  • GSK Investigational Site

    Petah Tikva, 49100

  • GSK Investigational Site

    Ramat Gan, 52621

  • GSK Investigational Site

    Rehovot, 76100

  • GSK Investigational Site

    Zrifin, 70300

Other trials in Israel

Philippines4 sites

  • GSK Investigational Site

    Cebu, 6000

  • GSK Investigational Site

    Manila, 1000

  • GSK Investigational Site

    Quezon City, 1101

  • GSK Investigational Site

    Sampaloc Manila, 1008

Other trials in Philippines

Thailand4 sites

  • GSK Investigational Site

    Bangkok, 10330

  • GSK Investigational Site

    Khon Kaen, 40000

  • GSK Investigational Site

    Lampang, 52000

  • GSK Investigational Site

    Phitsanulok, 65000

Other trials in Thailand

United Kingdom4 sites

  • GSK Investigational Site

    Bebington, Wirral, CH63 4JY

  • GSK Investigational Site

    London, SW3 6JJ

  • GSK Investigational Site

    Northwood, Middlesex, HA6 2RN

  • GSK Investigational Site

    Sutton, SM2 5PT

Other trials in United Kingdom

Chile3 sites

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500921

  • GSK Investigational Site

    Temuco, Región de La Araucania, 481-0469

  • GSK Investigational Site

    Viña del Mar, Valparaiso, 254-0364

Other trials in Chile

Czechia3 sites

  • GSK Investigational Site

    Brno, 656 53

  • GSK Investigational Site

    Hradec Králové, 500 05

  • GSK Investigational Site

    Prague, 180 00

Other trials in Czechia

Hong Kong3 sites

  • GSK Investigational Site

    Hong Kong

  • GSK Investigational Site

    Sheung Wan

  • GSK Investigational Site

    Tuenmen

Other trials in Hong Kong

Italy3 sites

  • GSK Investigational Site

    Milan, Lombardy, 20141

  • GSK Investigational Site

    Prato (PO), Tuscany, 59100

  • GSK Investigational Site

    Sassari, Sardinia, 07100

Other trials in Italy

Morocco3 sites

  • GSK Investigational Site

    Casablanca

  • GSK Investigational Site

    Hassan Rabat

  • GSK Investigational Site

    Rabat

Other trials in Morocco

Pakistan3 sites

  • GSK Investigational Site

    Lahore, 53400

  • GSK Investigational Site

    Lahore, 54600

  • GSK Investigational Site

    Multan, 60000

Other trials in Pakistan

Romania3 sites

  • GSK Investigational Site

    Bucharest, 022328

  • GSK Investigational Site

    Cluj-Napoca, 400015

  • GSK Investigational Site

    Iași, 700106

Other trials in Romania

South Korea3 sites

  • GSK Investigational Site

    Incheon, 400-711

  • GSK Investigational Site

    Seodaemun-gu, Seoul, 120-752

  • GSK Investigational Site

    Songpa-gu, Seoul, 138-736

Other trials in South Korea

Taiwan3 sites

  • GSK Investigational Site

    Changhua, 500

  • GSK Investigational Site

    Taipei, 112

  • GSK Investigational Site

    Tao-Yuan County, 333

Other trials in Taiwan

Tunisia3 sites

  • GSK Investigational Site

    Ariana, Tunis, 2080

  • GSK Investigational Site

    Sfax, 3000

  • GSK Investigational Site

    Sousse, 4000

Other trials in Tunisia

Canada2 sites

  • GSK Investigational Site

    Montreal, Quebec, H2L 4M1

  • GSK Investigational Site

    Montreal, Quebec, H4J 1C5

Other trials in Canada

Turkey (Türkiye)2 sites

  • GSK Investigational Site

    Istanbul, 34390

  • GSK Investigational Site

    Izmir

Other trials in Turkey (Türkiye)

Australia1 site

  • GSK Investigational Site

    Perth, Western Australia, 6000

Other trials in Australia

Egypt1 site

  • GSK Investigational Site

    Cairo, 11796

Other trials in Egypt

Greece1 site

  • GSK Investigational Site

    Athens, 185 47

Other trials in Greece

Peru1 site

  • GSK Investigational Site

    Lima, Lima Province, Lima 34

Other trials in Peru

Singapore1 site

  • GSK Investigational Site

    Singapore, 169610

Other trials in Singapore

About this study

Official title: A Randomized, Multicenter, Phase III Study Comparing the Combination of Pazopanib and Lapatinib Versus Lapatinib Monotherapy in Patients With ErbB2 Over-expressing Inflammatory Breast Cancer

The double blind part of the study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone in subjects with inflammatory breast cancer whose tumors overexpress the ErbB2 protein. There is also an Open-label pazopanib arm to this study designed to test whether pazopanib given alone and lapatinib given alone would be safe and effective to treat patients with inflammatory breast cancer.

Being tested
lapatinib, Pazopanib
Keywords
GW572016, Breast Cancer, RECIST, Inflammatory Breast Cancer, Pazopanib, ErbB2, Cutaneous Disease, Tykerb, Inflammatory, Skin, Her2, Lapatinib, GW786034
Medical subject headings
Breast Neoplasms, Inflammatory Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lapatinibDrug

    Also called Tykerb

    Oral administration

  • PazopanibDrug

    Also called Votrient

    Oral administration

Study groups in NCT00558103
Study groupRoleWhat they receive
arm 1Active comparatorLapatinib
Receives: Drug: lapatinib
arm2Active comparatorPazopanib monotherapy (open label)
Receives: Drug: Pazopanib
arm3ExperimentalLapatinib+ pazopanib
Receives: Drug: lapatinib; Drug: Pazopanib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Overall Response (OR), Defined as Those Participants Achieving Complete Response (CR) or Partial Response (PR), Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 and Cutaneous Lesions

    RECIST-based response assessment was done at Weeks (Wks) 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, CR is the disappearance of all target and non-target lesions; PR is at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools.

    Measured: Baseline until disease progression/recurrence was documented, assessed for up to 66 weeks

Secondary outcomes (3)

  1. Median Duration of Response,Defined as the First Documented Evidence of CR or PR Until the First Documentation of Disease Progression

    RECIST-based response assessment was done at Wks 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, PD is >=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools.

    Measured: From the date of the first documented evidence of CR or PR until the date of the first documented disease progression or death, assessed for up to 62 weeks

  2. Progression-free Survival, Defined as the Interval Between the Date of Randomization and the Earliest Date of Disease Progression (PD) or Death Due to Any Cause (Defined by an Investigator Review of Lesions Based on RECIST and Cutaneous Disease)

    RECIST-based response assessment was done at Wks 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, PD is >=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools.

    Measured: From the date of the randomization until the earliest date of disease progression or death due to any cause, assessed for up to 66 weeks

  3. Overall Survival

    Overall survival is defined as the time from randomization until death due to any cause. For participants who did not die, time to death was censored at the time of last contact.

    Measured: From the date of randomization until the date of death due to any cause, assessed for up to 163 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionMay 2011
  4. Study completionDec 2011

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00558103
Sponsor's protocol ID
VEG108838
Status last verified
Jan 2013
First submitted
9 Nov 2007
Last updated
4 Feb 2013
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lapatinib and Pazopanib in people with Neoplasms, Breast, run by GlaxoSmithKline at 126 sites in 28 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 42 inclusion and 38 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 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 126 sites in Germany, United States, France, Spain, Russia and 23 more countries. 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 18 Jul 2012). 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?

Number of Participants With Overall Response (OR), Defined as Those Participants Achieving Complete Response (CR) or Partial Response (PR), Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 and Cutaneous Lesions (time frame: Baseline until disease progression/recurrence was documented, assessed for up to 66 weeks). 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 NCT00558103.

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 4 Feb 2013.

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