A Clinical Trial With Apatinib for Subjects With Refractory Malignant Ascites

A Phase II, Single-Arm, Open-Label, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Apatinib in Patients With Refractory Malignant Ascites

Malignant ascites is a severe complication of many types of human cancer. Animal and clinical analyses have shown that angiogenesis plays a critical role in the formation of malignant ascites. Therefore, drugs such as apatinib that target angiogenesis may control the development of malignant ascites. The study is to evaluate the efficacy and safety of apatinib in patients with refractory malignant ascites.

Study Overview

• Status: Unknown
• Conditions: Malignant Ascites; Apatinib
• Intervention / Treatment: Drug: Apatinib

Detailed Description

The study is to investigate the efficacy and safety of apatinib in patients with refractory malignant ascites. A total of 120 patients with performance status 0-2 were enrolled in this study and 500mg apatinib tablets were administered orally, once daily until disease progression or intolerable toxicity or patients withdrawal of consent.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Qiong Wu, M.D. Ph.D.; Phone Number: +86-552-3074480; Email: byzlnk@163.com

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China
      • Recruiting
      • Qiong Wu
      • Contact: Rui Wang, MD; Phone Number: +86-0552-3074480; Email: byzlnk@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Persistent or symptomatic ascites with positive cytology secondary to any histologically confirmed tumor type not amenable to cytoreductive surgery or additional chemotherapy
• Patients may enroll in this study irrespective of previous therapy including diuretics, surgery, chemotherapy, immunotherapy and radiation therapy
• Must have received a minimum of two paracentesis procedures and a trial of diuretic therapy within 60 days of study entry
• Age Restrictions: 18-75 years
• Life Expectancy: 12 weeks or more
• ECOG Performance Status: 0-2
• Able and willing to provide informed consent and comply with study and/or follow-up procedures
• Normal organ and marrow function as defined by: Leukocytes >/= 3,000/mcL; Absolute neutrophil count >/= 1,500/mcL; Platelets >/= 100,000/mcL; Total bilirubin within normal institutional limits; AST (SGOT)/ALT(SGPT) </= 2.5 X institutional upper limit of normal (ULN); Creatinine within normal institutional limits OR Creatinine clearance >/+ 60 mL/min for patients with creatinine levels above the institutional normal; Serum Potassium within normal institutional limits; Serum Sodium within normal institutional limits

Exclusion Criteria:

• Patients having received anti-angiogenic agents as part of the treatment of their malignancy within 60 days prior to study entry
• Current, recent (within 30 days of the first infusion of this study) or planned administration of chemotherapy (including all routes of administration), immunotherapy, biologic therapy, radiation therapy or any other anti-angiogenic therapy (e.g., bevacizumab, other tyrosine kinase inhibitors)
• Current, recent (within 30 days of the first infusion of this study), or planned participation in any other experimental drug study
• Pregnant women; A serum pregnancy test will be given to females of childbearing potential prior to study enrollment and the participant must agree to use adequate contraception (barrier or hormonal methods) prior to study entry and for the duration of study participation.
• Un-controlled hypertension (defined as systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg
• History of hypertensive crisis or hypertensive encephalopathy
• New York Heart Association (NYHA) Grade III or greater congestive heart failure
• History of myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months prior to study entry
• Known CNS disease, except for treated brain metastasis.
• Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to study entry
• History of gastrointestinal hemorrhage within 6 month prior to study entry
• Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study entry or anticipation of need for major surgical procedure during the course of the study
• Core biopsy or other minor surgical procedure, excluding placement of a vascular access device or paracentesis/thoracentesis, within 7 days prior to study entry
• History of abdominal fistula or gastrointestinal perforation within 6 months prior to study entry
• Any bowel obstruction that has not fully recovered despite medical or surgical intervention prior to study entry
• Evidence of bowel wall thickening outside the site of the known primary malignancy on baseline radiographs
• Serious, non-healing wound, active ulcer, or untreated bone fracture
• Proteinuria as demonstrated by a Urine Protein/Creatinine ration >/= 1.0 at screening
• Known hypersensitivity to any component of apatinib.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 500mg apatinib; Patients will receive 500mg of apatinib tablet orally, once daily.	Drug: Apatinib; Patients will take 500mg apatinib daily orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The repeat paracentesis response rate (proportion of subjects who have a doubling of baseline time to repeat paracentesis)	12 weeks after initiation of study treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
The time to the need for the first repeat abdominal paracentesis after the start of apatinib therapy as compared with historical control data.	12 weeks after initiation of study treatment
The mean number of paracentesis procedures required in each patient over the course of three months.	12 weeks after the initiation of study treatment
The effect of apatinib therapy on quality of life in patients with malignant ascites by using EORTC QLQ-C30 V3.0.	12 weeks after the initiation of study treatment

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Bengbu Medical College

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: January 11, 2017
• First Posted (Estimate): January 13, 2017

Study Record Updates

• Last Update Posted (Actual): May 31, 2017
• Last Update Submitted That Met QC Criteria: May 30, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ascites; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: BYEC20161201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No