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Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00558103 |
This 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.
Condition | Intervention | Phase |
---|---|---|
Inflammatory Breast Cancer |
Drug: pazopanib (GW786034) Drug: lapatinib (Tykerb) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy 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 |
Estimated Enrollment: | 320 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Note: It is not necessary that informed consent be obtained within the protocol-specified screening window.
Table 1 Definitions for Adequate Organ Function:
Urine Protein to Creatinine Ratio2(<1)
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:
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.
Exclusion Criteria:
Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Blood pressure must be re-assessed on two occasions that are separated by a minimum of 24 hours. 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 Sections 6.2 and 6.4.2 for details on blood pressure control and reassessment prior to study enrollment.
Note: Patients with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible.
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | VEG108838 |
Study First Received: | November 9, 2007 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00558103 |
Health Authority: | United States: Food and Drug Administration |
Inflammatory Breast Cancer Pazopanib Lapatinib Tykerb Her2 |
ErbB2 GW786034 GW572016 Skin Cutaneous Disease RECIST |
Inflammatory breast cancer Skin Diseases Breast Neoplasms Lapatinib Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |