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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.