Neoplasms, Breast
Conditions
Keywords
Cancer, lapatinib, Combination therapy, Chronic administration
Brief summary
This study is designed to provide continued access to lapatinib as monotherapy or as part of a combination regimen to cancer subjects who are currently participating in a phase I trial that has met its study objectives.
Interventions
DRUGLapatinib in combination with an anti-cancer agent
Lapatinib in combination with paclitaxel, letrozole, capecitabine, capecitabine/oxaliplatin, gemcitabine, docetaxel, trastuzumab, FOLFOX4, or FOLFIRI
DRUGLapatinib
Lapatinib monotherapy
DRUGLapatinib in combination with an anti-cancer agent as specified by parent protocol
Lapatinib in combination with an anti-cancer agent as specified by parent protocol
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participation in a Phase I lapatinib trial that has met its study objectives. * Ability to understand and provide written informed consent to participate in this study. * Male or female greater than or equal to 18 years of age. * A female subject is eligible to participate if she is of: * Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods stated in the protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least two to four weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method. * Child-bearing potential, has a negative serum pregnancy test at baseline, and agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception from two weeks prior to the administration of study drug and throughout the entire active study treatment period until four weeks after the last dose of study medication.
Exclusion criteria
* Permanent discontinuation of lapatinib in the previous study due to intolerance or treatment failure. * Is a pregnant or lactating female. * Is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or baseline investigations. * Currently receiving treatment with any medications listed on the prohibited medication listed in the protocol * Has Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system. * Have current active hepatic or biliary disease (with exception of subjects with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability | Initiation of study treatment to discontinuation of study treatment |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy | Initiation of study treatment to discontinuation of study treatment |
Countries
Canada, Netherlands, South Korea, Spain, United States
Outcome results
None listed