Last updated: 11/03/2018 12:10:49
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
Continuation study of lapatinib monotherapy or lapatinib in combination with other anti-cancer agents
GSK study ID
111767
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: An Open-Label Phase Ib Continuation Study of Lapatinib Monotherapy or Lapatinib in Combination with Other Anti-Cancer Treatment in Patients with Solid Tumors
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Safety and tolerability
Timeframe: Initiation of study treatment to discontinuation of study treatment
Secondary outcomes:
Efficacy
Timeframe: Initiation of study treatment to discontinuation of study treatment
Interventions:
Drug: Lapatinib
Drug: Lapatinib in combination with an anti-cancer agent as specified by parent protocol
Drug: Lapatinib in combination with an anti-cancer agent
Enrollment:
297
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Neoplasms, Breast
Product
lapatinib
Collaborators
Not applicable
Study date(s)
October 2008 to June 2016
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- 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.
- Permanent discontinuation of lapatinib in the previous study due to intolerance or treatment failure.
- Is a pregnant or lactating female.
Inclusion and exclusion criteria
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).
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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
Additional information
Not applicable
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