Optimizing the Therapeutic Dose of Apatinib Mesylate Tablets in Patients With Lung Cancer by Dose Titration：A Real World Exploratory Study

NCT03594682 | Unknown

• 1 other identifier: HB-B001
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of two different administration methods of apatinib in NSCLC patients.

Conditions

NSCLC Stage IV; NSCLC Stage IIIB

Keywords

Apatinib,NSCLC,Dose titration

Outcome Measures

Primary Outcomes (1)

• duration of treatment

  time from take apatinib to withdrawal from experiment due to adverse reaction of apatinib

  two years

Study Arms (2)

dose titration group

EXPERIMENTAL

First of all, according to the patient's weight and ECOG score, patients were divided into three groups（the initial dose of 250 mg qd,250 mg/500 mg qd by turns, 500 mg qd）. in two weeks, if the patient who is intolerant of the initial dose,250mg qod,250mg qd ,250mg qd was selected. if the patient can tolerate the dose well,a high-dose was given,and the maximum dose does not exceeding 750mg qd.

Other: Intervention/treatment

non-titration group

ACTIVE COMPARATOR

Patients were given 750mg qd apatinib until disease progression or intolerance

Other: Intervention/treatment

Interventions

Intervention/treatment OTHER

experimentalgroup initial dose： 1. 250mg qod 2. 250mg qd/500mg qd by turn 3. 500mg qd control group： 750mg qd

dose titration group; non-titration group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18；
• Locally advanced/metastatic non-small lung cancer (IIIb / IV) confirmed by pathology with measurable lesions ；
• Patients with wild type EGFR/ALK must received two kinds of systemic chemotherapy before；Patients with EGFR mutation positive had experienced treatment failure with TKI in first line and Chemotherapy in second line ；
• ECOG：0-4；
• The subjects were treated with other drugs has been restored (NCI CTCAE version 4.0 class 1 or less), which accept nitroso urea or mitomycin interval 6 weeks or more; Accept other cytotoxic drugs, bevacizumab (Avastin) (except local palliative radiotherapy), radiotherapy or surgery four weeks or more. EGFR TKI ≥2 weeks; Main organs function is normal；
• Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib. For man, surgical sterilization should be performed, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib；
• Patients voluntarily entered the study and signed informed consent form (ICF).

You may not qualify if:

• brain MRI, CT or venography confirmed that there are brain hemorrhage symptoms；
• Tumor invade big vessels or close to big vessels (less than 5mm)；
• Patients with uncontrollable hypertension (systolic blood pressure\> 140 mmHg, diastolic blood pressure\> 90 mmHg, despite optimal drug therapy).；
• Patients with with grade Ⅱ myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male ≥ 450 ms, female ≥470 ms)；
• Abnormal coagulation (INR\>1.5 or PT\>ULN+4, or APTT\>1.5 ULN), bleeding tendency or receiving coagulation therapy
• Urine protein≥++, or urine protein in 24 hours≥1.0g
• CTCAE 2 degrees or more peripheral neuropathy, except the trauma;
• Unhealed bone fracture or wound for long time；
• Patients who received systemic antibiotic treatment of serious infections;
• Decompensated diabetes or high dose of glucocorticoid treatment other banned disease;
• Patients with active hepatitis B virus or hepatitis c virus infection；
• Patients with obvious factors affecting absorption of oral drugs, such as difficulties in swallowing, chronic diarrhea and intestinal obstruction, etc.
• Received big surgery, had bone fracture or ulcer in 4 weeks.
• Within 6 weeks before random severe weight loss (\> 10%);
• Patients who experienced bleeding symptoms of clinical significance within 3 months before screening, or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc；

Sponsors & Collaborators

• Beijing Chest Hospital: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Methods; Therapeutics

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Li Baolan

  Beijing Chest Hospital

  STUDY DIRECTOR

Central Study Contacts

Hu Ying

CONTACT

010-89509330; huying2004@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director,Department of oncology

Study Record Dates

• First Submitted: June 24, 2018
• First Posted: July 20, 2018
• Study Start: August 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2020
• Last Updated: July 20, 2018

Record last verified: 2018-06