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

NCT ID: NCT03480256

Last Updated: 2019-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-27
• Study Completion Date: 2020-08-31

Brief 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.

Conditions

Gastric Cancer

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR6390 combined with pyrotinib

Group A:pyrotinib 400mg qd combined with SHR 6390 100mg qd Group B: pyrotinib 400mg qd combined with SHR 6390 125mg qd Group C: pyrotinib 400mg qd combined with SHR 6390 150mg qd Group D: pyrotinib 400mg qd combined with SHR 6390 175mg qd Group E: pyrotinib 320mg qd combined with SHR 6390 100mg qd

Group Type: EXPERIMENTAL

SHR6390

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Shen Lin

Head of Department of Gastrointestinal Oncology,Peking University Cancer Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lin Shen

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Department of GI Oncology, Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Jifang Gong

Role: CONTACT

goodjf@163.com

13683208528

Facility Contacts

Shen Lin, Professor

Role: primary

Linshenpku@163.com

010-88196561

Jifang Gong, MD

Role: primary

gongjifang@gmail.com

861088196561

References

Chen Z, Xu Y, Gong J, Kou F, Zhang M, Tian T, Zhang X, Zhang C, Li J, Li Z, Lai Y, Zou J, Zhu X, Gao J, Shen L. Pyrotinib combined with CDK4/6 inhibitor in HER2-positive metastatic gastric cancer: A promising strategy from AVATAR mouse to patients. Clin Transl Med. 2020 Aug;10(4):e148. doi: 10.1002/ctm2.148.

Reference Type: DERIVED

PMID: 32898333 (View on PubMed)

Other Identifiers

SHR6390-Id

Identifier Type: -

Identifier Source: org_study_id