A One-Arm Exploratory Clinical Trial of Apatinib Plus Gemcitabine in Patients With Advanced Metastatic Pancreatic Cancer

NCT02863367 | Unknown Phase 2 DMC

• 1 other identifier: AHEAD-HBP001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluate the efficacy and safety of Apatinib (500mg/d) with gemcitabine(1000mg/m2) in advanced metastatic pancreatic cancer.

Conditions

Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  1 years

Secondary Outcomes (5)

• progression-free survival (PFS)

  1 years

• Overall Survival (OS)

  1 years

• Life Quality Score (QoL)

  1 years

• Disease Control Rate (DCR)

  1 years

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  1 years

Study Arms (1)

Treatment group

EXPERIMENTAL

Apatinib：500 mg，po，qd, d1-14, every 3 week Gemcitabine：1000mg/m²，vein input 30-40，d1，d8，every 3 week

Drug: Apatinib; Drug: Gemcitabine

Interventions

Apatinib DRUG

Apatinib：500 mg，po，qd, d1-14, every 3 week

Also known as: YN968D1

Treatment group

Gemcitabine DRUG

Gemcitabine：1000mg/m²，vein input 30-40，d1，d8，every 3 week

Treatment group

Eligibility Criteria

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

You may qualify if:

• Age of patients ranges from 18 to 75 years old.
• Must not received radiotherapy, chemotherapy or experimental treatment for advanced metastatic pancreatic cancer. Transfer of postoperative recurrence of patients with advanced pancreatic cancer can also be into the group.
• Karnofsky Performance Status Scale (KPS) ≥70.
• The first confirmed date of advanced metastatic pancreatic cancer not more than 6 weeks before starting treatment.
• No jaundice symptoms. Obviously abdominal water or have symptoms, need a drainage in advance. Don't need to adjust the analgesic therapy.
• Adequate hematologic functions :Hemoglobin (HGB) ≥ 90g/dL, Platelets (PLT) ≥ 100×10\^9/L, the absolute number of Neutrophil (ANC) ≥ 1.5×10\^9/L.
• Adequate hepatic, renal, heart functions :Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×the upper limit of normal (ULN).If liver metastases, AST and ALT ≤5.0×the ULN. Total bilirubin within the ULN. Serum Creatinine within the ULN, or creatinine clearance ≥ 60 mL/min.
• Blood coagulation test results: Prothrombin Time (PT) and Partial Thromboplastin Time (PPT) within ±15% of the normal.
• No clinically significant abnormal urine analysis results.
• Women with pregnancy or lactation, or fertility but during treatment and 6 months after treatment of termination unwilling or unable to use effective contraception to avoid pregnancy patients with male or female
• Signed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
• Patient consent and well compliance, scheduled to accept the visits, treatment, laboratory tests and other study procedures

You may not qualify if:

• Patients with the known brain metastases.
• Patients with locally advanced disease only.
• Decline in serum albumin (ALB) ≥ 20% from the screening visit to cycle 1 day 1 prior to the 72 hours.
• Over the past five years has a history of malignant tumors (including chronic leukemia). Patients with carcinoma in situ or basal cell carcinoma or squamous cell skin cancer can be selected.
• With need of systemic treatment activity, unable to control bacterial, viral or fungal infections
• Known HIV infection, or active hepatitis B or hepatitis C virus (HCV) infection.
• A major surgery (not include the diagnostic surgery) not more than 4 weeks before starting treatment.
• In the period of 6 months before starting treatment, Patients with myocardial infarction, severe or unstable angina, coronary artery and peripheral artery bypass grafting, New York heart association (NYHA) three - four level cardiac failure, out of control of high blood pressure, Patients with clinical significance of arrhythmia or abnormal electrocardiogram (ECG), cerebrovascular accident, transient ischemic attack, epilepsy, or with clinical significance of arrhythmia or a history of abnormal electrocardiogram (ECG).
• Has any study drug or its accessories history of allergies or allergic reactions, or patients showed this product or controlled drug prescribing information "contraindications or special warnings and precautions" section Outlines of events.
• The history of connective tissue disease (such as lupus, scleroderma, nodular arteritis).
• Has a history of interstitial pneumonia, slowly progressive dyspnea and cough, sarcoidosis, and silicosis, idiopathic pulmonary fibrosis, hypersensitivity pneumonitis, or a variety of allergies.
• Could damage patient safety or the integrity of the data to any situation, including severe medical risk factors, medical events and laboratory abnormalities or mental illness;
• Enter any other clinical study, some involved in drug test, or may interfere with the study in the program evaluation;
• The patient is not willing to or cannot meet research program, or plans for vacation during the research and treatment more than 7 days or seven days;
• The investigator think that the person doesn't fit into the study.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

apatinib; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Hao Ji Hui, PhD

  National Clinical Research Center for Cancer of China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Ji Hui, PhD

CONTACT

022-23340123; renhe@tjmuch.com

Ren He, PhD

CONTACT

022-23340123; renhe@tjmuch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: August 11, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 11, 2016

Record last verified: 2016-07