Telatinib in Combination With Capecitabine/ Oxaliplatin in 1st Line Gastric or GEJ Cancer

NCT03817411 | Unknown Phase 2 FDA Drug

• 1 other identifier: EOC315B2101
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the trial is to compare the combination regimen of Telatinib and Capecitabine and Oxaliplatin vs. Capecitabine and Oxaplatin to explore superiority of the Telatinib combination in terms of progression-free survival (PFS) in patients previously untreated for advanced HER2 negative advanced gastric or Gastroesophageal Junction adenocarcinoma.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  the proportion of patients with complete response (CR) or partial response (PR) among all patients assessed per RESIST v1.1.

  24 months

Secondary Outcomes (3)

• PFS

  24 months

• CBR

  24 months

• DCR

  24 months

Study Arms (2)

Telatinib+Capecitabine+Oxaliplatin

ACTIVE COMPARATOR

Patients receive Telatinib orally (PO) twice daily (bid) on days 1-21 and Capecitabine PO on days 1-14, then stopped for 7 days, and Oxaliplatin by intravenous injection on day 1 of every cycle. Courses repeat every 21 days.

Drug: Telatinib; Drug: Capecitabine; Drug: Oxaliplatin

Placebos+Capecitabine+Oxaliplatin

PLACEBO COMPARATOR

Patients receive placebo orally (PO) twice daily (bid) on days 1-21 and Capecitabine PO on days 1-14, then stopped for 7 days, and Oxaliplatin by intravenous injection on day 1 of every cycle. Courses repeat every 21 days.

Drug: Capecitabine; Drug: Oxaliplatin; Drug: Placebos

Interventions

Telatinib DRUG

300 mg tablets, 900 mg twice daily (BID) at 12h-intervals.

Also known as: EOC315

Telatinib+Capecitabine+Oxaliplatin

Capecitabine DRUG

1000 mg/m²,twice daily for 14 days followed by a 7-day rest period (14 days on/7 days off schedule).

Placebos+Capecitabine+Oxaliplatin; Telatinib+Capecitabine+Oxaliplatin

Oxaliplatin DRUG

130 mg/m2, administered intravenously over 2 hours, on Day 1 every 3 weeks (one administration per cycle) for a maximum of 6 cycles.

Placebos+Capecitabine+Oxaliplatin; Telatinib+Capecitabine+Oxaliplatin

Placebos DRUG

300 mg tablets, 900 mg twice daily (BID) at 12h-intervals.

Placebos+Capecitabine+Oxaliplatin

Eligibility Criteria

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

You may qualify if:

• Male or female at least 18 and \<75 years old at the time of screening.
• Histologically or cytologically confirmed unresectable locally advanced or metastatic HER2 negative (or HER2 status unknown), gastric or gastro-oesophageal junction adenocarcinoma.
• Measurable or evaluable lesion as defined by RECIST v1.1.
• No prior treatment for advanced disease. Adjuvant or neoadjuvant chemotherapy must be stopped at least for 6 months.
• Prior surgery and/or radiotherapy stopped for at least 4 weeks.
• ECOG Performance Status 0-1.
• Life expectancy of at least 3 months.
• Adequate bone marrow function as evidenced by meeting all of the following requirements:
• Absolute neutrophil count \> 1.5 × 10 E+9/L without the use of hematopoietic growth factors
• Platelet count \> 90 ×10 E+9/L without the need for transfusion in the 2 weeks prior the first dose
• Hemoglobin \>90 g/L without the need for transfusion in the 2 weeks prior the first dose
• Adequate hepatic function as evidenced by meeting all of the following requirements:
• Serum total bilirubin ≤1.5 x upper limit of normal (ULN) (biliary drainage is allowed for biliary obstruction)
• Serum albumin levels ≥3.0 g/dL
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) and and alkaline phosphatase (ALP): ≤3.0 x upper limit of normal (ULN) (≤5 x ULN if liver metastases are present and if liver and/or bone metastases ALP ≤ 5 × ULN.)

You may not qualify if:

• Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure \> 150 mmHg, diastolic blood pressure \> 100 mmHg).
• Active and uncontrolled central nervous system (CNS) metastases .
• During the screening and study period, standard dose of anticoagulant or thrombolytic drugs are used for treatment;
• History of any second malignancy in the last 5 years; patients with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they have been continuously disease free for at least 5 years.
• Evidence of tumor invasion of major blood vessels by images(including complete proximity, surrounding or extending into the main vascular lumen, such as the pulmonary artery or the superior vena cava), and the investigator judged that it was not suitable for enrollment.
• A significant thrombotic or hemorrhagic event ≤ 6 months prior to Screening (includes hemoptysis, gastrointestinal bleeding, hematemesis, CNS hemorrhage, severe epistaxis or vaginal bleeding, cerebral infarction, transient ischemic attacks, myocardial infarction, angina, and uncontrolled coronary artery disease).
• History of active gastroduodenal ulcer, abdominal fistula as well as nongastrointestinal fistula, gastrointestinal perforation or intraabdominal abscess within 6 months prior to screening.
• Significant cardiac conduction abnormalities, including a history of long QTc syndrome and/or pacemaker.New York Heart Association Class III or IV congestive heart failure, ventricular arrhythmias
• Exposure to any other investigational or commercial anticancer agents or therapies (Chinese herbal medicines e.g) administered with the intention to treat malignancy within 28 days.
• Active infection or an unexplained fever during screening visits or on the first scheduled day of dosing (at the discretion of the Investigator, patients with tumor fever may be enrolled), which in the investigator's opinion might compromise the patient's participation in the trial or affect the trial outcome.
• Positive test or known history of for human immunodeficiency virus (HIV), active hepatitis B (HBsAg) or hepatitis C (anti-HCV antibody) or syphilis (syphilis antibody)
• If female, the patient is pregnant or lactating at the time of enrollment.
• Known hypersensitivity to any of the components of fluoropyrimidines or platinum cmpounds.

Sponsors & Collaborators

• Taizhou EOC Pharma Co., Ltd.: lead
• Shanghai East Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator

Study Sites (1)

Shanghai Easter Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

telatinib; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Jin Li, M.D.

  Shanghai Easter Hospital, Dpt. of Clinical Oncology

  STUDY CHAIR

• Tian Shu Liu, M.D.

  Shanghai Fudan Zhongshan Hospital, Dpt. of Clinical Oncology

  STUDY CHAIR

Central Study Contacts

Peng Wang, M.S.

CONTACT

18606193900; peng.wang@eocpharma.com

Jie Li, M.S.

CONTACT

18951813306; jie.li@eocpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 25, 2019
• Study Start: January 25, 2019
• Primary Completion: March 30, 2020
• Study Completion: January 25, 2021
• Last Updated: May 7, 2019

Record last verified: 2019-01

Locations

CN (1)