Study to Evaluate SHR6390 Combined With Pyrotinib in Patients With HER2 Positive Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Phase Id Trial to Evaluate SHR6390 Combined With Pyrotinib in Patients With HER2 Positive Advanced Stage Gastric Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03480256
• Other study ID #: SHR6390-Id
• Status: Recruiting
• Phase: Phase 1
• Start date: July 27, 2018
• Est. completion date: August 2020

Study information

• Verified date: March 2019
• Source: Peking University
• Contact: Jifang Gong
• Phone: 13683208528
• Email: goodjf[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to assess the safety and tolerability of SHR6390 combined with pyrotinib in the patients with Her-2 positive advanced gastric cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients definitely diagnosed by pathology as Her2 positive stage III/IV gastric cancer

• 18-75 years old, ECOG PS:0-1,Life expectancy of more than12 weeks;

• Patients treated with systematic treatment to metastatic disease then experienced progressive disease

• Patients with at least one evaluable or measurable disease per RECIST v1.1

• Main organs function is normal;

• Patients should be voluntary and sign the informed consent before taking part in the study;

Exclusion Criteria:

• • Patients who have uncontrollable effusion with clinical symptoms such as severe pleural effusion and peritoneal effusion;

• A variety of factors that affect oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.)

• Patients who have steroid treatment for more than 30 days or need long-term steroid treatment;

• Patients who had previously received chemotherapy,radiotherapy, hormonotherapy,surgery,targeted therapy(including Trastuzumab) within 2 weeks ;patients who had previously received nitrosourea or Mitomycin with 6 weeks;

• Previous treatment-related adverse events did not recover to less than 2 levels except hair loss or other conditions that did not affect the enrollment according to investigators;

• Patients who have participated in other anticancer drug clinical trials within 4 weeks except that trial is observational or at follow up stage;

• Patients who have uncontrollable hypomagnesemia or hypokalemia;

• Patients with untreated or symptomatic brain metastasis;

• Patients with malignant tumors within 5 years, except for basal cell carcinoma,squamous skin cancer and cervical carcinoma in situ;

• Patients who are being treated with any other anticancer strategies;

• Patients with allergic constitution or being allergic to any element in the study drugs;

• Patients with definite gastrointestinal bleeding tendency, including: active ulcer lesions with OB(++);melena or haematemesis history within 2 months; patients with OB(+) but without tumor resection need gastroscopy. If there is active bleeding, it's not suitable for this trial;

• Patients with active infection, including tuberculosis;

• Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history;

• Patients who have had severe cardiac disease within six months, including acute coronary syndrome, arrhythmias that require medication or with clinical significance, or need continuous medication that may cause QT extension, acute myocardial infarction,heart failure,and any other condition that is not suitable for this experiment according to the investigators;

• Patients who are pregnant or breast feeding;

• Patients who don't agree on contraception; Patients with concomitant diseases which could seriously endanger themselves or those who won't complete the study according to investigators such as hypertension, severe diabetes and thyroid diseases;

• Patients with bad addiction such as excessive drinking or smoking;

• Patients with definite mental disorder, including epilepsy and dementia.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• SHR6390
SHR6390 is a novel small molecule inhibitor specifically targeting the CDK4/6 pathway.Pyrotinib is an irreversible pan-ErbB inhibitor which shows promising antitumour activity in patients with HER2-positive metastatic gastric cancer

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Department of GI Oncology, Peking University Cancer Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD)		42 days
Secondary	Maximum Plasma Concentration		42 days
Secondary	Area Under the Curve		42 days