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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01931943
• Other study ID #: QLSLTN-102
• Status: Recruiting
• Phase: Phase 1
• First received: August 25, 2013
• Last updated: August 27, 2013
• Start date: April 2013

Study information

• 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

Clinical Trial 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.

Description:

1. To evaluate the safety and tolerability of oral Selatinib Ditosilate Tablets, and explore the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).

2. To determine the pharmacokinetic profile of single and multi oral Selatinib Ditosilate Tablets .

3. To determine preliminary dose and regimen for phase II study of oral Selatinib Ditosilate Tablets.

4. To assess preliminary antitumor activity .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• selatinib ditosilate tablets

Locations

Country	Name	City	State
China	Cancer Institute and Hospital,Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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