PK Study for Endostar Continuous Intravenous Infusion in NSCLC Patients With 1st-line Platinum Based Chemotherapy

NCT04942301 | Unknown Phase 1

• 1 other identifier: SIM-1904-04-ENDO-101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is an open-label, randomized, multicenter study to explore Endostar in combination with standard platinum-based chemotherapy with different methods in patients with advanced/metastatic non-small cell lung cancer (NSCLC)

Conditions

Advanced or Metastatic NSCLC

Outcome Measures

Primary Outcomes (10)

• peak time (Tmax)

  pharmacokinetic parameters

  At the end of the second cycle, each cycle is 21 days

• peak concentration (Cmax)

  pharmacokinetic parameters

  At the end of the second cycle, each cycle is 21 days

• area under curve (AUC, Including AUC0-t, AUC0-∞)

  pharmacokinetic parameters

  At the end of the second cycle, each cycle is 21 days

• terminal elimination half-life (T1/2)

  pharmacokinetic parameters

  At the end of the second cycle, each cycle is 21 days

• steady-state minimum blood concentration (CSS min)

  pharmacokinetic parameters

  At the end of the second cycle, each cycle is 21 days

• mean steady-state blood concentration (CSS AV)

  pharmacokinetic parameters

  At the end of the second cycle, each cycle is 21 days

• accumulation coefficient (RAC)

  pharmacokinetic parameters

  At the end of the second cycle, each cycle is 21 days

• mean residence time (MRT)

  pharmacokinetic parameters

  At the end of the second cycle, each cycle is 21 days

• apparent volume of distribution (VD)

  pharmacokinetic parameters

  At the end of the second cycle, each cycle is 21 days

• clearance rate (CL)

  pharmacokinetic parameters

  At the end of the second cycle, each cycle is 21 days

Secondary Outcomes (1)

• Adverse events (AE) incidence

  through study completion, an average of 1 year

Other Outcomes (3)

• The objective response rate (ORR)

  through study completion, an average of 1 year

• disease control rate (DCR)

  through study completion, an average of 1 year

• the progression-free survival

  through study completion, an average of 1 year

Study Arms (2)

Endostar pump for three days

EXPERIMENTAL

Group A: The first cycle, Endostar 7.5mg/m2/day, intravenous infusion for 4 hours, D1-14 First 2-4 cycles, Endo 105mg/m2/cycle D1 starts intravenous pump for 72 hours;

Drug: Endostar; Device: use the vein pump to pump drugs; Combination Product: combination therapy

Endostar pump for seven days

EXPERIMENTAL

Group B: Cycle 1, Endo 7.5mg/m2/day, intravenous infusion for 4 hours, D1-14 First 2-4 cycles, Endo 105mg/m2/cycle D1 starts intravenous pump injection for 168 hours;

Drug: Endostar; Device: use the vein pump to pump drugs; Combination Product: combination therapy

Interventions

Endostar DRUG

This product combined with other combined chemotherapeutics is used to treat patients with stage III/IV NSCLC who are newly treated or relapsed

Also known as: recombinant human endostatin injection

Endostar pump for seven days; Endostar pump for three days

use the vein pump to pump drugs DEVICE

During the first 14 days of the first cycle, the experimental drug was pumped daily with an intravenous pump. During cycles 2-4, subjects in group A were pumped with experimental drugs for 3 days and subjects in group B were pumped with experimental drugs for 7 days.

Also known as: vein pump

Endostar pump for seven days; Endostar pump for three days

combination therapy COMBINATION_PRODUCT

Combination therapy with chemotherapy drugs was used

Endostar pump for seven days; Endostar pump for three days

Eligibility Criteria

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

You may qualify if:

• Volunteer to participate in clinical trials and sign an informed consent form.
• Age ≥ 18 years old, including gender.
• Advanced or metastatic NSCLC confirmed by histology and/or cytology: Have not received Systemic chemotherapy for advanced disease (Patients with sensitive mutations such as EGFR and ALK have received corresponding standard alternative treatments, But patients who have not received chemotherapy can be included in the group; have received single-agent PD-L 1 and other immune checkpoint inhibitors Patients, but patients who have not received chemotherapy can enter the group).
• At least one measurable lesion (based on RECIST 1.1).
• ECOG scores 0\~1.
• Expected survival time ≥ 3 months.
• The functions of major organs are basically normal, and the laboratory test values during the screening period meet the following standards:
• System Laboratory Inspection Standard hematology Absolute neutrophil count \>1.5 ×109/L Platelet \>100×109/L Hemoglobin \>90g/L kidney Serum creatinine or Creatinine clearance rate (CrCl) or glomerular filtration rate (GFR) (Cockcroft-Gault formula) \<1.5 × ULN or \>60 mL/min1.73m2 (for patients with creatinine level ≥ 1.5 × ULN) liver Total bilirubin (serum) \<2.5 × ULN or Direct bilirubin \<ULN (for patients with total bilirubin level ≥ 1.5×ULN) AST and ALT \<2.5 × ULN or ≤5 × ULN (for patients with liver metastases) Blood clotting International normalized ratio (INR) or prothrombin time (PT) \<1.5 × ULN, unless the patient is receiving anticoagulation therapy
• Urine routine Urine protein ≤+ (For patients with urine protein ≥++, 24-hour urine protein quantification is required, and 24-hour urine protein needs to be less than 1g)
• · Women of childbearing age during the screening period had negative blood pregnancy test results. The patient agrees to self-sign and know Consent to use reliable contraceptive methods within 90 days after the end of treatment.

You may not qualify if:

• Patients with uncontrolled primary central nervous system tumors, brain metastases, or meningeal metastases. Patients who were asymptomatic or had their symptoms under treatment (stable and asymptomatic at least 4 weeks after treatment) were allowed to join the group.
• Imaging (CT, PET-CT, or MRI) shows tumors invading large blood vessels.
• It is first clear that pulmonary hemorrhage/hemoptysis (\> 1/2 teaspoon about 2.5ml bright red blood) or other clinically significant bleeding symptoms or obvious bleeding possibility occurred in the first 3 months.
• Severe uncontrollable hypertension (defined as systolic blood pressure\> 150mmHg and/or diastolic blood pressure\> 100mg, or accompanied by hypertensive crisis, hypertensive encephalopathy).
• The QTcF interval of ECG\> 480ms within 6 months before the first first time.
• Severe infections within 4 weeks before the first administration require intravenous antibiotics or hospitalization.
• Before the first dose, the adverse events caused by any intervention have not recovered to normal or ≤1 grade. Patients with alopecia (any grade) and sensory neuropathy (≤2 grade) at both ends can be included in the group.
• Received other major surgery besides diagnosis or biopsy within 4 weeks before the first definition.
• weeks or 5 half-lives before the first time (for investigational drugs with known half-lives) internally as a patient Received experimental drug treatment.
• Previously received anti-angiogenic drug treatment.
• Received systemic anti-tumor therapy within 4 weeks before the first dose, including chemotherapy, macromolecular targeting, immunotherapy, and endocrine therapy; within 2 weeks before the first dose or within 5 half-lives of the drug (whichever is longer) ) Receiving small-molecule targeted drug therapy; receiving Chinese/herbal medicine with anti-tumor indications within 2 weeks before the first dose.
• Patients who have received adjuvant chemotherapy within 6 months before the first dose and the disease recurs within 6 months after the start of adjuvant therapy.
• Obvious gastrointestinal bleeding (such as esophageal or gastric varices) or a clear bleeding tendency occurred within 4 weeks before the first dose.
• Those who are allergic to any active or inactive ingredients of Endo or the combined chemotherapeutics.
• Known acute or active hepatitis B, or chronic hepatitis C, or syphilis infection, or human immunodeficiency virus (HIV) infection.

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Lan Mu

Shanghai, Shanghai Municipality, 210000, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

endostar protein; Endostatins; Combined Modality Therapy

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)

Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors; Therapeutics

Study Officials

• xiaojian zhang

  the director of the IRB

  PRINCIPAL INVESTIGATOR

Central Study Contacts

qingxia fan

CONTACT

13939039058; fqx2243@126.com

wei he

CONTACT

18638553286

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 28, 2021
• Study Start: July 30, 2021
• Primary Completion: December 25, 2021
• Study Completion: October 15, 2022
• Last Updated: June 30, 2021

Record last verified: 2021-06

Locations

CN (1)