Advanced Breast Cancer Clinical Trial
Official title:
A Phase Ib Study to Evaluate the Tolerability and Pharmacokinetics of Selatinib Ditosilate Tablets in Patients With Advanced Breast Cancer
NCT number | NCT01931943 |
Other study ID # | QLSLTN-102 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 1 |
First received | August 25, 2013 |
Last updated | August 27, 2013 |
Start date | April 2013 |
Verified date | August 2013 |
Source | Qilu Pharmaceutical Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Cancer Institute and Hospital,Chinese Academy of Medical Sciences | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Qilu Pharmaceutical Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose-limiting toxicity(DLT) | 21 days | Yes | |
Primary | Maximum tolerated dose(MTD) | 21 days | Yes | |
Secondary | Pharmacokinetics | Selatinib Ditosilate pharmacokinetic parameters , include AUC, Cmax, Tmax, and t1/2 | 21 days | No |
Secondary | Pharmacodynamics | The response of Salatinib Ditosilate on tumor measured by CT or MRI. | 7 weeks | No |
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