Who is sponsoring NCT01199367?

NCT01199367 is sponsored by Kyowa Kirin Co., Ltd..

What drugs are being tested in NCT01199367?

Interventions in NCT01199367: KW-2450 in combination with lapatinib and letrozole.

What condition does NCT01199367 study?

NCT01199367 studies Breast Cancer.

Is NCT01199367 still recruiting?

NCT01199367 is currently terminated. Last updated 23 April 2024.

Last reviewed 2024-04-23 · How we verify

NCT01199367

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

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of KW-2450 in Combination With Lapatinib and Letrozole in Subjects With Advanced or Metastatic Breast Cancer Whose Tumors Overexpress HER2

Terminated Phase 1 Last updated 23 April 2024

What this trial tests

Phase 1 trial testing KW-2450 in combination with lapatinib and letrozole in Breast Cancer in 11 participants. Terminated before completion.

Timeline

1 December 2010

Primary endpoint
1 December 2012

1 December 2012

Quick facts

Lead sponsor	Kyowa Kirin Co., Ltd.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	1 December 2010
Primary completion	1 December 2012
Estimated completion	1 December 2012
Sites	5 locations across United States

Drugs / interventions tested

KW-2450 in combination with lapatinib and letrozole — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

Kyowa Kirin Co., Ltd. — full company profile →

Who can join

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

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

To establish the safety, tolerability, and recommended Phase 2 dose of KW-2450 administered in combination with lapatinib and letrozole in subjects with previously treated or untreated advanced breast cancer.
Time frame: 30 Days

Sponsor's own description

This study will determine the highest dose of KW-2450 in combination with lapatinib and letrozole that can be administered safely to subjects with advanced or metastatic breast cancer and to evaluate its effectiveness. This study was terminated in Phase 1 and never proceeded to the Phase 2 portion of the study.

Publications & conference data

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

Insulin-Like Growth Factor (IGF) Pathway Targeting in Cancer: Role of the IGF Axis and Opportunities for Future Combination Studies.
Simpson A, Petnga W, Macaulay VM, Weyer-Czernilofsky U, et al · · 2017 · cited 127× · PMID 28815409 · DOI 10.1007/s11523-017-0514-5
Modulation of insulin-like growth factor-1 receptor and its signaling network for the treatment of cancer: current status and future perspectives.
Jin M, Buck E, Mulvihill MJ. · · 2013 · cited 15× · PMID 25992224 · DOI 10.4081/oncol.2013.e3
Preclinical and phase I clinical studies of KW-2450, a dual IGF-1R/IR tyrosine kinase inhibitor, in combination with lapatinib and letrozole.
Umehara H, Maekawa Y, Koizumi F, Shimizu M, et al · · 2018 · cited 2× · PMID 30083253 · DOI 10.1177/1758835918786858

Verify or expand the search:

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other Kyowa Kirin Co., Ltd. trials

Trials by the same sponsor.

NCT06926491 — Evaluate the Efficacy and Safety of KK8398 in Patients With Achondroplasia（AOBA Study） · Phase 3 · recruiting
NCT06812104 — Clinical Trial of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia · Phase 1 · recruiting
NCT06525636 — A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia · Phase 1, PHASE2 · recruiting
NCT06116890 — Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration · Phase 2 · active not recruiting
NCT06116916 — Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema · Phase 2 · active not 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 NCT01199367 (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 Kyowa Kirin Co., Ltd.
Last refreshed: 23 April 2024

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/NCT01199367.

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