A Phase Ib Study of Selatinib Ditosilate Tablets in Patients With Advanced Breast Cancer
Primary Purpose
Advanced Breast Cancer
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
selatinib ditosilate tablets
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Breast Cancer
Eligibility 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.
Sites / Locations
- Cancer Institute and Hospital,Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Selatinib Ditosilate Tablets
Arm Description
Selatinib Ditosilate either at 450,750,1000,1250mg, p.o. once daily
Outcomes
Primary Outcome Measures
Dose-limiting toxicity(DLT)
Maximum tolerated dose(MTD)
Secondary Outcome Measures
Pharmacokinetics
Selatinib Ditosilate pharmacokinetic parameters , include AUC, Cmax, Tmax, and t1/2
Pharmacodynamics
The response of Salatinib Ditosilate on tumor measured by CT or MRI.
Full Information
NCT ID
NCT01931943
First Posted
August 25, 2013
Last Updated
August 27, 2013
Sponsor
Qilu Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01931943
Brief Title
A Phase Ib Study of Selatinib Ditosilate Tablets in Patients With Advanced Breast Cancer
Official Title
A Phase Ib Study to Evaluate the Tolerability and Pharmacokinetics of Selatinib Ditosilate Tablets in Patients With Advanced Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Pharmaceutical Co., Ltd.
4. Oversight
5. Study Description
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.
Detailed Description
To evaluate the safety and tolerability of oral Selatinib Ditosilate Tablets, and explore the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).
To determine the pharmacokinetic profile of single and multi oral Selatinib Ditosilate Tablets .
To determine preliminary dose and regimen for phase II study of oral Selatinib Ditosilate Tablets.
To assess preliminary antitumor activity .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Selatinib Ditosilate Tablets
Arm Type
Experimental
Arm Description
Selatinib Ditosilate either at 450,750,1000,1250mg, p.o. once daily
Intervention Type
Drug
Intervention Name(s)
selatinib ditosilate tablets
Primary Outcome Measure Information:
Title
Dose-limiting toxicity(DLT)
Time Frame
21 days
Title
Maximum tolerated dose(MTD)
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Pharmacokinetics
Description
Selatinib Ditosilate pharmacokinetic parameters , include AUC, Cmax, Tmax, and t1/2
Time Frame
21 days
Title
Pharmacodynamics
Description
The response of Salatinib Ditosilate on tumor measured by CT or MRI.
Time Frame
7 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Cancer Institute and Hospital,Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qing Li
Email
cheryliqing@aliyun.com
First Name & Middle Initial & Last Name & Degree
Qing Li
First Name & Middle Initial & Last Name & Degree
Binghe Xu
12. IPD Sharing Statement
Citations:
PubMed Identifier
27902470
Citation
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.
Results Reference
derived
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A Phase Ib Study of Selatinib Ditosilate Tablets in Patients With Advanced Breast Cancer
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