Tracking Information
Start Date ICMJE | December 2007 |
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Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: March 26, 2009) | Progression-free survival at anytime. [ Time Frame: on going ] |
Original Primary Outcome Measures ICMJE (submitted: November 9, 2007) | Progression-free survival at anytime. [ Time Frame: survival at anytime ] |
Change History | Complete list of historical versions of study NCT00558103 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: March 26, 2009) | Overall Response Rate (ORR)Overall survival (OS)Safety and tolerabilityHealth Status Assessments [ Time Frame: on going ] |
Original Secondary Outcome Measures ICMJE (submitted: November 9, 2007) | Overall Response Rate (ORR) Overall survival (OS) Safety and tolerability Health Status Assessments [ Time Frame: Overall survival ] |
Descriptive Information
Brief Title ICMJE | Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Inflammatory Breast Cancer |
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Official Title ICMJE | 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 |
Brief 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. 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. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Inflammatory Breast Cancer |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 360 | ||||
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Estimated Completion Date | June 2012 | ||||
Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion criteria: 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:
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 Laboratoraties 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).
Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:
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:
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. Exclusion Criteria:
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.
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Gender | Female | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Australia, Belgium, Canada, Chile, China, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, Israel, Italy, Korea, Republic of, Morocco, Pakistan, Peru, Philippines, Romania, Russian Federation, Singapore, Spain, Taiwan, Thailand, Turkey, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00558103 | ||||
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Responsible Party | Study Director, GSK | ||||
Study ID Numbers ICMJE | VEG108838 | ||||
Study Sponsor ICMJE | GlaxoSmithKline | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | GlaxoSmithKline |