NCT00258050 is a Phase 1 clinical trial of Midazolam in Neoplasms, Breast, sponsored by GlaxoSmithKline.

Who is sponsoring NCT00258050?

NCT00258050 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00258050?

Interventions in NCT00258050: Midazolam, Lapatinib.

What condition does NCT00258050 study?

NCT00258050 studies Neoplasms, Breast.

Is NCT00258050 still recruiting?

NCT00258050 is currently completed. Last updated 6 December 2017.

Last reviewed 2017-12-06 · How we verify

NCT00258050

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

To Examine The Effects Of Lapatinib On Orally And Intravenously Administered Midazolam In Cancer Patients

Completed Phase 1 Last updated 6 December 2017

What this trial tests

Phase 1 trial testing Midazolam in Neoplasms, Breast in 24 participants. Completed in 8 February 2007.

Timeline

21 November 2005

Primary endpoint
8 February 2007

8 February 2007

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	21 November 2005
Primary completion	8 February 2007
Estimated completion	8 February 2007
Sites	2 locations across United States

Drugs / interventions tested

Midazolam (midazolam) — full drug profile →
Lapatinib (LAPATINIB) — full drug profile →

Conditions studied

Neoplasms, Breast — all drugs for Neoplasms, Breast →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 70, any sex, with Neoplasms, Breast. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To characterize the effect of repeat oral dose of lapatinib treatment on the pharmacokinetics of a single oral and single intravenous dose of midazolam in adult cancer patients. Also to assess the safety and tolerability of chronic oral lapatinib therapy in cancer patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Path to Clonal Theranostics in Luminal Breast Cancers.
Hajjaji N, Aboulouard S, Cardon T, Bertin D, et al · · 2021 · cited 7× · PMID 35096604 · DOI 10.3389/fonc.2021.802177

Verify or expand the search:

Other trials of Midazolam

Trials testing the same drug.

NCT05945147 — Ketamine and Midazolam Infusions for CRPS: Feasibility Study · Phase 2 · withdrawn
NCT07525544 — A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants · Phase 1 · not yet recruiting
NCT07426757 — An Open-Label Study to Evaluate PF-07994525 in Participants With Advanced Cancers · Phase 1 · not yet recruiting
NCT07435194 — A Clinical Trial in Healthy Participants to Learn How Itraconazole Affects MK-2828 Levels and How MK-2828 Affects Midazo · Phase 1 · recruiting
NCT07443254 — Prospective IR-led Sedation Feasibility · Phase 1, PHASE2 · recruiting

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 NCT00258050 (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: 6 December 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/NCT00258050.

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