A Phase Ib Study of Selatinib Ditosilate Tablets in Patients With Advanced Breast Cancer

NCT01931943 | Unknown Phase 1

• 1 other identifier: QLSLTN-102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity(DLT)

  21 days

• Maximum tolerated dose(MTD)

  21 days

Secondary Outcomes (2)

• Pharmacokinetics

  21 days

• Pharmacodynamics

  7 weeks

Study Arms (1)

Selatinib Ditosilate Tablets

EXPERIMENTAL

Selatinib Ditosilate either at 450,750,1000,1250mg, p.o. once daily

Drug: selatinib ditosilate tablets

Interventions

selatinib ditosilate tablets DRUG

Selatinib Ditosilate Tablets

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women aged 18-65.
• Patients with ECOG performance status of 0 or 1.
• Expected life-expectancy of more than 3 months.
• Patients must have histologically or cytologically confirmed breast cancer. Either the primary breast tumor or the metastasis must overexpress HER2; acceptable methods of measurement of HER2 expression include immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH); tumors tested by IHC must be 3+ positive for HER2 overexpression immunohistochemistry ; tumors tested by FISH must be positive.
• Prior Herceptin therapy is discontinued because of disease progression or patients can not afford for Herceptin therapy.
• patients with at least one measurable lesion (RECIST1.1 criteria).
• Hematology： WBC≥3.5×109/L, ANC≥1.5×109/L, PLT≥100×109/L，HB≥90g/L;
• Biochemistry： Serum bilirubin≤1.5 times upper limit of normal (ULN),AST and ALT ≤1.5 times ULN; creatinine and urea nitrogen≤1.5 times ULN; LVEF≥50%, ECG normal, and Fridericia corrected QT(QTcF)\<470ms.
• patients receiving damage caused by other therapeutic has been restored, the interval more than six weeks since the last receiving nitroso or mitomycin; more than 4 weeks since last receiving radiotherapy, other cytotoxic drugs or surgery.
• Subjects can swallow and have normal gastrointestinal function.
• Female subjects should agree to take contraceptives during the study and within 6 months after the study (such as intrauterine device \[IUD\], contraceptive drugs or condoms); within 7 days before they enter the study, their serum or human chorionic gonadotropin should be negative, and must be in the non-lactation period.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Patients have uncontrolled large pleural effusion and ascites.
• Patients have received steroid for more than 50 days, or requiring for steroid therapy for a long time.
• Requirement for the therapeutic drugs prolonging QT interval(such as anti-arrhythmia drugs), and can not interrupt them.
• Patients with a history of symptomatic brain metastases.
• Patients have received small molecule targeted drug therapy of inhibition of HER-2 or EGFR.
• Patients have participated in other drug clinical research in the past 4 weeks.
• Pregnant or lactating women are excluded from this study.
• Patients with a history of allergic reactions attributed to compounds of similar chemical composition to the agents used in the study are ineligible;
• Patients with active infection ;
• Patients with cardiac disease including Angina, any significant or need to be treated arrhythmia，Myocardial infarction, Heart failure, LVEF\<45%, other heart diseases that are not suitable for participating in the study judged by investigator.
• Patients with other concurrent severe and/or uncontrolled medical conditions （including hypertension, severe diabetes, thyroid disease, etc.) that could cause unacceptable safety risks or compromise compliance with study requirements are ineligible.
• Patients with a history of mental disorders, including epilepsy or dementia are ineligible.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Cancer Institute and Hospital,Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (1)

• Zhang T, Li Q, Chen S, Luo Y, Fan Y, Xu B. Phase I study of QLNC120, a novel EGFR and HER2 kinase inhibitor, in pre-treated patients with HER2-overexpressing advanced breast cancer. Oncotarget. 2017 May 30;8(22):36750-36760. doi: 10.18632/oncotarget.13581.

  PMID: 27902470 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2013
• First Posted: August 30, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2013
• Last Updated: August 30, 2013

Record last verified: 2013-08

Locations

CN (1)