NCT00359190 is a Phase 1 clinical trial of lapatinib in Neoplasms, Breast, sponsored by GlaxoSmithKline.

Who is sponsoring NCT00359190?

NCT00359190 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00359190?

Interventions in NCT00359190: lapatinib.

What condition does NCT00359190 study?

NCT00359190 studies Neoplasms, Breast.

Is NCT00359190 still recruiting?

NCT00359190 is currently completed. Last updated 13 November 2017.

Last reviewed 2017-11-13 · How we verify

NCT00359190

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pharmacokinetics And Pharmacodynamics Of Lapatinib In Two Dosing Regimens In Treatment-naive Patients With Breast Cancer

Completed Phase 1 Last updated 13 November 2017

What this trial tests

Phase 1 trial testing lapatinib in Neoplasms, Breast in 28 participants. Completed in 9 January 2008.

Timeline

29 June 2004

Primary endpoint
9 January 2008

9 January 2008

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	29 June 2004
Primary completion	9 January 2008
Estimated completion	9 January 2008
Sites	10 locations across United States, Israel

Drugs / interventions tested

lapatinib (LAPATINIB) — full drug profile →

Conditions studied

Neoplasms, Breast — all drugs for Neoplasms, Breast →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Neoplasms, Breast. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will examine the inhibition of ErbB1 and ErbB2 phosphorylation and downstream mediators of tumor cell growth and survival tumor tissue in treatment-naive breast cancer patients for three dosing schedules of lapatinib.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Deregulating MYC in a model of HER2+ breast cancer mimics human intertumoral heterogeneity.
Risom T, Wang X, Liang J, Zhang X, et al · · 2020 · cited 42× · PMID 31763993 · DOI 10.1172/jci126390
Lapatinib Plasma and Tumor Concentrations and Effects on HER Receptor Phosphorylation in Tumor.
Spector NL, Robertson FC, Bacus S, Blackwell K, et al · · 2015 · cited 24× · PMID 26571496 · DOI 10.1371/journal.pone.0142845

Verify or expand the search:

Other trials of lapatinib

Trials testing the same drug.

NCT01891357 — Phase II Trial to Validate Markers for a Response Evaluation of a Combined Therapy in Patients With HER2+ Breast Cancer · Phase 2 · terminated
NCT01875666 — Defining the HER2 Positive (+) Breast Cancer Kinome Response to Trastuzumab, Pertuzumab, Combination Trastuzumab +Pertuz · EARLY_PHASE1 · completed
NCT01808573 — A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cance · Phase 3 · completed
NCT00996762 — A Study in Cancer Patients to Evaluate the Bioequivalence of Alternative Formulations of Lapatinib · Phase 1 · completed
NCT00953576 — Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer · Phase 1, PHASE2 · terminated

Other recruiting trials for Neoplasms, Breast

Currently open trials in the same condition.

NCT06819215 — Phase I/II Clinical Study to Evaluate VB15010 Tablets in Patients With Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT04915755 — Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HE · Phase 3 · active not recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00359190 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 13 November 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00359190.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing