Who is sponsoring NCT01931943?

NCT01931943 is sponsored by Qilu Pharmaceutical Co., Ltd..

What drugs are being tested in NCT01931943?

Interventions in NCT01931943: selatinib ditosilate tablets.

What condition does NCT01931943 study?

NCT01931943 studies Advanced Breast Cancer.

Is NCT01931943 still recruiting?

NCT01931943 is currently status unknown. Last updated 27 August 2013.

Last reviewed 2013-08-27 · How we verify

NCT01931943

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

A Phase Ib Study to Evaluate the Tolerability and Pharmacokinetics of Selatinib Ditosilate Tablets in Patients With Advanced Breast Cancer

Status unknown Phase 1 Last updated 27 August 2013

What this trial tests

Phase 1 trial testing selatinib ditosilate tablets in Advanced Breast Cancer in 24 participants. Status unknown.

Timeline

1 April 2013

Primary endpoint
1 December 2013

Quick facts

Lead sponsor	Qilu Pharmaceutical Co., Ltd.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	1 April 2013
Primary completion	1 December 2013
Sites	1 location across China

Drugs / interventions tested

selatinib ditosilate tablets — full drug profile →

Conditions studied

Advanced Breast Cancer — all drugs for Advanced Breast Cancer →

Sponsor

Qilu Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 18 to 65, female only, with Advanced 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.

Dose-limiting toxicity(DLT)
Time frame: 21 days
Maximum tolerated dose(MTD)
Time frame: 21 days

Sponsor's own description

Brief Description: This study is designed to evaluate the safety and tolerability of oral Selatinib Ditosilate Tablets, and explore the maximum tolerated dose (MTD) and dose-limiting toxicity in patients with advanced breast cancer.

Publications & conference data

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

Phase I study of QLNC120, a novel EGFR and HER2 kinase inhibitor, in pre-treated patients with HER2-overexpressing advanced breast cancer.
Zhang T, Li Q, Chen S, Luo Y, et al · · 2017 · cited 3× · PMID 27902470 · DOI 10.18632/oncotarget.13581

Verify or expand the search:

Other recruiting trials for Advanced Breast Cancer

Currently open trials in the same condition.

NCT07408089 — Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer · Phase 1 · recruiting
NCT07318805 — A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors · Phase 1 · recruiting
NCT07259226 — Optimal Methods to Characterize ADC Resistance in Solid Tumors and Identify Clinically Useful Biomarkers · Phase 2 · recruiting
NCT06982521 — Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PI · Phase 3 · recruiting
NCT07428655 — Acceptability and Feasibility of PSC Model of Serious Illness Communication · NA · active not recruiting

Other Qilu Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT07511647 — A Phase 3 Clinical Study of QL2106 Injection · Phase 3 · not yet recruiting
NCT07467629 — QLS5212 for Participants With Advanced Solid Tumors · Phase 1 · not yet recruiting
NCT07455006 — Safety and Efficacy Study of QL0911 to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients · Phase 3 · not yet recruiting
NCT07463573 — QLC5508 vs. Chemotherapy in Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma · Phase 3 · not yet recruiting
NCT07444086 — QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia · Phase 3 · 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 NCT01931943 (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 Qilu Pharmaceutical Co., Ltd.
Last refreshed: 27 August 2013

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/NCT01931943.

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