Last updated: 11/07/2018 16:17:31
Genotyping Amendment for Genetic Research Conducted as part of Clinical Pharmacology Study EGF10004: An Open Label, Safety, Pharmacokinetic, and Pharmacodynamic Study of Multiple Doses of GW572016 to Examine the Inhibition of EGFR/erbB-2 Auto-phosphorylation in Cancer 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: Genotyping Amendment for Genetic Research Conducted as part of Clinical Pharmacology Study EGF10004: An Open Label, Safety, Pharmacokinetic, and Pharmacodynamic Study of Multiple Doses of GW572016 to Examine the Inhibition of EGFR/erbB-2 Auto-phosphorylation in Cancer Patients with Solid Tumors
Trial description: Genotyping Amendment for Genetic Research Conducted as part of Clinical Pharmacology Study EGF10004: An Open Label, Safety, Pharmacokinetic, and Pharmacodynamic Study of Multiple Doses of GW572016 to Examine the Inhibition of EGFR/erbB-2 Auto-phosphorylation in Cancer 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:
Burris HA III, Hurwitz HI, E. Dees C, et al. Phase I Safety, Pharmacokinetics, and Clinical Activity Study of Lapatinib (GW572016), a Reversible Dual Inhibitor of Epidermal Growth Factor Receptor Tyrosine Kinases, in Heavily Pretreated Patients With Metastatic Carcinomas. J Clin Oncol 23:5305-5313, 2005.
N.Spector, W. Xia, H. A. Burris, H. Hurwitz, et al. Modulation of Tumor Growth and Survival Pathways in Cancer Patients Treated with GW572016.Proc ASCO 2004;23:195 (Abs 3003).
S.S. Bacus, B. Smith, Y. Yarden, et al. Differences in Response of Breast Cancer Molecular Profiles of Patients Likely to Respond to Either Tyrosine Kinase Inhibitors or to erbB Targeted Therapies. Proc ASCO 2004;23:219 (Abs 3097).
Spector N, Raefsky E, Hurwitz H, et al. Safety, Clinical Efficacy, and Biologic Assessments from EGF10004: A randomized Phase IB study of GW572016 for Patients With Metastatic Carcinomas Overexpressing EGFR and ErbB2. Proc ASCO 2004;23:225 (Abs 3188).
Spector NL, Xia W, Burris HA III, et al. Study of the Biologic Effects of Lapatinib, a Reversible Inhibitor of ErbB1 and ErbB2 Tyrosine Kinases, on Tumor Growth and Survival Pathways in Patients With Advanced Malignancies. J Clin Oncol 23:2502-2512, 2005.
Medical condition
Neoplasms, Breast
Product
lapatinib
Collaborators
Not applicable
Study date(s)
March 2002 to August 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
2004-19-08
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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