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

NCT03480256 | Unknown Phase 1 DMC

• 1 other identifier: SHR6390-Id
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Keywords

SHR6390; Pyrotinib; gastric cancer; Her-2 positive

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD)

  42 days

Secondary Outcomes (2)

• Maximum Plasma Concentration

  42 days

• Area Under the Curve

  42 days

Study Arms (1)

SHR6390 combined with pyrotinib

EXPERIMENTAL

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

Drug: SHR6390

Interventions

SHR6390 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

SHR6390 combined with pyrotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (2)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Department of GI Oncology, Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 32898333 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Lin Shen

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jifang Gong

CONTACT

13683208528; goodjf@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Gastrointestinal Oncology,Peking University Cancer Hospital

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 29, 2018
• Study Start: July 27, 2018
• Primary Completion: November 1, 2019
• Study Completion: August 1, 2020
• Last Updated: March 14, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)