NCT01340846 is a Phase 1 clinical trial of Warfarin in Cancer, sponsored by GlaxoSmithKline.

Who is sponsoring NCT01340846?

NCT01340846 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT01340846?

Interventions in NCT01340846: Warfarin, Ketoconazole, Gemfibrozil, GSK2118436 150mg, GSK2118436 75mg.

Is NCT01340846 still recruiting?

NCT01340846 is currently completed. Last updated 13 November 2017.

Last reviewed 2017-11-13 · How we verify

NCT01340846

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

A Pharmacokinetics Study of the Effects of GSK2118436 on Warfarin, the Effects of Ketoconazole and Gemfibrozil on GSK2118436, and the Effects of Repeat Doses of GSK2118436 in Subjects With BRAF Mutant Solid Tumors

Completed Phase 1 Last updated 13 November 2017

What this trial tests

Phase 1 trial testing Warfarin in Cancer in 48 participants. Completed in 14 November 2012.

Timeline

3 September 2012

Primary endpoint
14 November 2012

14 November 2012

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	3 September 2012
Primary completion	14 November 2012
Estimated completion	14 November 2012
Sites	11 locations across United Kingdom, United States, Australia

Drugs / interventions tested

Warfarin (warfarin) — full drug profile →
Ketoconazole (ketoconazole) — full drug profile →
Gemfibrozil (Gemfibrozil) — full drug profile →
GSK2118436 150mg
GSK2118436 75mg — full drug profile →

Conditions studied

Cancer — all drugs for Cancer →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

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

Sponsor's own description

GSK2118436 is an orally administered, potent and selective small molecule BRAF inhibitor that is being developed for the treatment of BRAF mutation-positive tumors. This is a 4-part study (in 4 separate cohorts of subjects) designed to examine the interaction potential of GSK2118436, either as a perpetrator (i.e., effect of GSK2118436 on warfarin; Part A) or victim (i.e., effect of other drugs on GSK2118436; Part B: ketoconazole and Part C: gemfibrozil), as well as to evaluate the single and repeat dose pharmacokinetic parameters of GSK2118436 (Part D). A sufficient number of subjects will be screened to obtain approximately 12 evaluable subjects each for Part A, Part B, Part C and Part D. Following completion of this study, subjects may continue dosing with GSK2118436 in the roll-over study, Protocol BRF114144.

Publications & conference data

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

The MAPK pathway across different malignancies: a new perspective.
Burotto M, Chiou VL, Lee JM, Kohn EC. · · 2014 · cited 773× · PMID 24948110 · DOI 10.1002/cncr.28864
Cotreatment of hairy cell leukemia and melanoma with the BRAF inhibitor dabrafenib.
Blachly JS, Lozanski G, Lucas DM, Grever MR, et al · · 2015 · cited 23× · PMID 25583765 · DOI 10.6004/jnccn.2015.0004
A comprehensive AI-driven analysis of large-scale omic datasets reveals novel dual-purpose targets for the treatment of cancer and aging.
Pun FW, Leung GHD, Leung HW, Rice J, et al · · 2023 · cited 21× · PMID 37888486 · DOI 10.1111/acel.14017

Verify or expand the search:

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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 NCT01340846 (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/NCT01340846.

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