Last updated: 11/07/2018 16:18:06
A Phase I, Open-Label, Three-Period, Randomized, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of GW572016 in Cancer Patients With a Continuation PHase to Evaluate the Safety of GW572016 Administered Once Daily
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase I, Open-Label, Three-Period, Randomized, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of GW572016 in Cancer Patients With a Continuation PHase to Evaluate the Safety of GW572016 Administered Once Daily
Trial description: A Phase I, Open-Label, Three-Period, Randomized, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of GW572016 in Cancer Patients With a Continuation PHase to Evaluate the Safety of GW572016 Administered Once Daily
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Koch KM, Reddy NJ, Cohen R, Lewis N, Whitehead B, Mackay K, Stead A, Beelen AP, Lewis LD.Effects of Food on the Relative Bioavailability of Lapatinib in Cancer Patients.J Clin Oncol.2009;27(8):1191-6
Medical condition
Neoplasms, Breast
Product
lapatinib
Collaborators
Not applicable
Study date(s)
January 2004 to December 2004
Type
Not applicable
Phase
1
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
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
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2004-10-12
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
Not applicable
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