NCT00034281 is a Phase 1 clinical trial of TAK-165 in Breast Neoplasm, sponsored by Takeda.

Who is sponsoring NCT00034281?

NCT00034281 is sponsored by Takeda.

What drugs are being tested in NCT00034281?

Interventions in NCT00034281: TAK-165.

What condition does NCT00034281 study?

NCT00034281 studies Breast Neoplasm, Pancreatic Neoplasm, Lung Neoplasm, Ovarian Neoplasm, Renal Neoplasm.

Is NCT00034281 still recruiting?

NCT00034281 is currently completed. Last updated 31 January 2012.

Last reviewed 2012-01-31 · How we verify

NCT00034281

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

A Phase I, Open-Label, Dose Escalating, Multiple Dose Study to Determine the Safety, Tolerability, Maximum Tolerated Dose and Pharmacokinetics of Oral TAK-165 Administered Once Daily to Subjects With Tumors Known to Express HER2.

Completed Phase 1 Last updated 31 January 2012

What this trial tests

Phase 1 trial testing TAK-165 in Breast Neoplasm in 16 participants. Completed in 1 September 2003.

Timeline

1 June 2002

Primary endpoint
1 September 2003

1 September 2003

Quick facts

Lead sponsor	Takeda
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	1 June 2002
Primary completion	1 September 2003
Estimated completion	1 September 2003
Sites	4 locations across United States

Drugs / interventions tested

TAK-165 — full drug profile →

Conditions studied

Breast Neoplasm — all drugs for Breast Neoplasm →
Pancreatic Neoplasm — all drugs for Pancreatic Neoplasm →
Lung Neoplasm — all drugs for Lung Neoplasm →
Ovarian Neoplasm — all drugs for Ovarian Neoplasm →

Sponsor

Takeda — full company profile →

Who can join

18 and older, any sex, with Breast Neoplasm or Pancreatic Neoplasm. 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.

Dose Limiting Toxicity
Time frame: Days 8, 15, 22, 28 and every 14 days thereafter to Final Visit
Maximum Tolerated Dose
Time frame: Days 8, 15, 22, 28 and every 14 days thereafter to Final Visit
Optimal Dosing for Phase II Studies.
Time frame: End of Study.

Sponsor's own description

The purpose of this study is to investigate a safe dose of TAK-165, once daily (QD), in patients with HER2-tumor expression.

Publications & conference data

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

Targeting of promising transmembrane proteins for diagnosis and treatment of pancreatic ductal adenocarcinoma.
Mashayekhi V, Mocellin O, Fens MHAM, Krijger GC, et al · · 2021 · cited 16× · PMID 34522225 · DOI 10.7150/thno.60350
Feasibility and Safety of Targeting Mitochondria Function and Metabolism in Acute Myeloid Leukemia.
Firmanty P, Chomczyk M, Dash S, Konopleva M, et al · · 2024 · cited 3× · PMID 40756330 · DOI 10.1007/s40495-024-00378-8

Verify or expand the search:

Other recruiting trials for Breast Neoplasm

Currently open trials in the same condition.

NCT07054723 — Surviving Daily Life · recruiting
NCT06839001 — CRYoablation for Small Tumors As Local Treatment - SIX Trial · Phase 3 · recruiting
NCT06672302 — A Prospective Study to Develop and Clinically Validate an in Vitro Diagnostic Medical Device That Uses Blood to Classify · recruiting
NCT06255808 — Development of Assist Tool for Breast Examination Using the Principle of Ultrasonic Sensor · active not recruiting
NCT06622967 — KNUCH CadAI-B-1(KCB-1) · NA · active not recruiting

Other Takeda trials

Trials by the same sponsor.

NCT05669729 — A Survey to Assess Participants', Caregivers', and Nurses' Use and Understanding of Educational Material on Velagluceras · not yet recruiting
NCT07403968 — A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease · Phase 2 · not yet recruiting
NCT07293364 — A Study to Learn About the C1-Inhibitor Function as Diagnosis for Hereditary Angioedema · NA · not yet recruiting
NCT07218393 — A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt · not yet recruiting
NCT07445087 — A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea · 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 NCT00034281 (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 Takeda
Last refreshed: 31 January 2012

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/NCT00034281.

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