Last updated: 11/07/2018 03:34:55
A Study to Examine the Effects of Low and High-fat Meals on Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An Open Label Study to Examine the Effects of Low-Fat and High-Fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients
Trial description: This study will be a randomized 3-treatment, cross-over study to evaluate the bioavailability of lapatinib administered after a high or low-fat meal.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Protocol specified pharmacokinetic parameters
Timeframe: 3 weeks
Secondary outcomes:
Safety and tolerability as assessed by evaluation of adverse events (AEs), changes in laboratory values, and vital signs
Timeframe: 3 weeks
Interventions:
Drug: Lapatinib
Enrollment:
24
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
L.A. Devriese, K.M. Koch, M. Mergui-Roelvink, G.M. Matthys, W.W. Ma, A. Robidoux, J.J. Stephenson, Q.S.C. Chu, J.H.M. Schellens , K.W. Orford, L. Cartee, N.Arya, and J.D. Botbyl. lapatinib-1MS-00026591 EGF111582 - Effects of low-fat and high-fat meals on steady-state pharmacokinetics of lapatinib in patients with advanced solid tumors. Invest New Drugs. 2013;32(3):481-8
Medical condition
Neoplasms, Breast
Product
lapatinib
Collaborators
Not applicable
Study date(s)
March 2009 to March 2011
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- Metastatic, histologically confirmed breast cancer that over-expresses ErbB2 (3+ by IHC; FISH or CISH positive).
- Is at least 18 years of age and not greater than 65 years of age.
- Is pregnant or lactating.
- Has malabsorption syndrome, a disease affecting gastrointestinal function, or resection of the stomach or small bowel.
Inclusion and exclusion criteria
Inclusion criteria:
- Metastatic, histologically confirmed breast cancer that over-expresses ErbB2 (3+ by IHC; FISH or CISH positive).
- Is at least 18 years of age and not greater than 65 years of age.
- Is male or female. A female is eligible to enter and participate in the study if she is of: a. 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, or is post-menopausal (a demonstration of total cessation of menses for ≥ 1 year) or in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory. b. Childbearing potential, has a negative serum pregnancy test at Screening and agrees to one of the following: double-barrier contraception (condom with spermicidal jelly, foam, suppository, or film; diaphragm with spermicide; or male condom and diaphragm); complete abstinence from sexual intercourse from two weeks prior to administration of the study drug, throughout the active study treatment period; vasectomized partner who is sterile prior to the female subject’s entry and is the sole sexual partner for that female.
- Is able to swallow and retain oral medication.
- ECOG performance status 0 to 2.
- Adequate bone marrow function.
- Hemoglobin ≥ 9 gm/dL.
- Absolute granulocyte count ≥1,500/mm3 (1.5 x 109/L).
- Platelets ≥ 75,000/mm3 (75 x 109/L).
- Calculated creatinine clearance (CrCl) ≥ 50 ml/min based on Cockcroft and Gault
- Total bilirubin ≤ 1.5 X upper limit of normal of institutional values and INR ≤ 1.5.
- Alanine transaminase (ALT) ≤ three times the upper limit of the institutional values or ≤ five times ULN with documented liver metastases.
- Has a left ventricular ejection fraction (LVEF) within the normal institutional range based on ECHO or MUGA.
- Life expectancy of ≥12 weeks
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion criteria:
- Is pregnant or lactating.
- Has malabsorption syndrome, a disease affecting gastrointestinal function, or resection of the stomach or small bowel.
- Has 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).
- Has evidence of symptomatic or uncontrolled brain metastases or leptomeningeal disease. Subjects with brain metastases treated by surgery and/or radiotherapy are eligible if neurologically stable and do not require steroids or anticonvulsants.
- Is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations.
- Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the investigational product such as gefitinib [Iressa] and erlotinib [Tarceva].
- Has received treatment with any investigational drug in the previous four weeks.
- Has received chemotherapy, immunotherapy, biologic therapy or hormonal therapy for the treatment of cancer within the past 14 days, with the exception of mitomycin C which is restricted for the past six weeks.
- Is receiving any prohibited medication within the timeframe indicated on the prohibited medication list for this study.
- Has physiological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
- Has inadequate venous access for protocol-related blood draws.
- Clinically significant electrocardiogram (ECG) abnormality.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Has consumed red wine, seville oranges, grapefruit or grapefruit juice and/or kumquats, pummelos, exotic citrus fruit (i.e. star fruit, bitter melon), grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
Trial location(s)
Location
GSK Investigational Site
Buffalo, New York, United States, 14263
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29605
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2011-22-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 111582 can be found on the GSK Clinical Study Register.
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