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
Study complete
Study complete
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:
Enrollment:
24
Primary completion date:
Not applicable
Observational study model:
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
Study complete
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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