Last updated: 11/07/2018 16:17:20
A Phase I, Open-label, Multiple-dose, Dose-escalation Study of GW572016 in Patients with Solid Tumors
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, Multiple-dose, Dose-escalation Study of GW572016 in Patients with Solid Tumors
Trial description: A Phase I, Open-label, Multiple-dose, Dose-escalation Study of GW572016 in Patients with Solid Tumors
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:
DA Smith, KM Koch, D Lee, S Mangum, A Stead, M Versola, T DeBerardinis, HA Burris III, S Jones, N Spector. The effect of food on the pharmacokinetics of GW572016. Eur J Cancer 2003, 1(Suppl 5), 558.
KM Koch, D Lee, S Mangum, A Stead, M Versola, HA Burris III, G Wilding, C Taylor, N Spector, DA Smith. Pharmacokinetics of GW572016 in an ascending dose tolerability study of phase I cancer subjects. Eur J Cancer 2003, 1(Suppl 5), 559.
L Pandite, HA Burris III, S Jones, G Wilding, C Taylor, M Versola, DA Smith, A Stead, KM Koch, N Spector. A safety, tolerability, and pharmacokinetic (PK) study of GW572016 in patients with solid tumors. Proc Amer Soc Clin Oncol 2004, 23:239(3179)
M Versola, HA Burris III, S Jones, G Wilding, C Taylor, L Pandite, DA Smith, A Stead, NL Spector. Clinical Activity of GW572016 in EGF10003 in patients with solid tumors. Proc Amer Soc Clin Oncol 2004, 22:3047
Medical condition
Neoplasms, Breast
Product
lapatinib
Collaborators
Not applicable
Study date(s)
September 2001 to October 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
2004-07-10
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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