Rh-Endostatin (Endostar®) Continuous Intravenous Infusion

• ClinicalTrials.gov Identifier: NCT03706703
• Recruitment Status: Unknown
• First Posted: October 16, 2018
• Last Update Posted: October 17, 2018
• Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
• Information provided by (Responsible Party): Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Study Description

Brief Summary:

Endostar is a anti-angiogenesis product and has been launched in China . The efficacy and safety have been defined. However, the compliance is unsatisfactory since routine i.v of Endostar is needed for 3 to 4 hours daily during one cycle of 14 days. The continuous intravenous infusion by using venous pump can improve the compliance.

Condition or disease	Intervention/treatment	Phase
Lung Cancer	Drug: Endostar; Drug: Docetaxel; Drug: Carboplatin; Drug: Pemetrexed	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Safety and Efficacy of Rh-Endostatin (Endostar®) Continuous Intravenous Infusion in Combination With Docetaxel/Carboplatin or Pemetrexed/Carboplatin (DC/PC) Regimens for Untreated Stage IIIB/IV Non-small-cell Lung Cancer (NSCLC)
• Actual Study Start Date: October 1, 2018
• Estimated Primary Completion Date: April 1, 2020
• Estimated Study Completion Date: September 1, 2020

Arms and Interventions

Arm

Intervention/treatment

Experimental: Endostar continuous intravenous infusion; Endostar continuous intravenous infusion in combination with docetaxel/carboplatin or pemetrexed/carboplatin

Drug: Endostar; continuous intravenous infusion Endostar,7.5mg/m2, continuous intravenous infusion for 14 days each cycle, 21 days as one cycle, 4 cycles in total.; Drug: Docetaxel; docetaxel is 75 mg/m2 intravenously over 1 hour on Day 1 of each 21-day cycle; Drug: Carboplatin; carboplatin is administered on Day 1 of each 21-day，followed by docetaxol or pemetrexed; Drug: Pemetrexed; pemetrexed is 500 mg/m2 intravenously on Days 1 of each 21-day cycle

Outcome Measures

Primary Outcome Measures :

1. ORR [ Time Frame: 8 weeks ]
   objective response rate based on Recist 1.1 edition

Secondary Outcome Measures :

1. PFS [ Time Frame: 8 weeks ]
   progress free survival

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion criteria:

Primary non-small cell lung cancer confirmed by cytology and histology, excluding sputum examination;

Phase IIIB/IV based on TNM criteria (8th);

At least one measurable tumor based on RECIST 1.1;

Without the known active mutation of EGFR/ALK/ROS1/RET;

Male or female, age≥18 or ≤70 years old;

ECOG PS: 0 or 1;

Estimated time of survival: ≥ 3 months;

Suitable hematologic function: ANC≥2×109/L, PLC≥100×109/L and Hb≥9 g/dL;

Suitable liver function: Total bilirubin≤ normal ULN, AST and ALT≤2.5×normal ULN, ALP≤ 5×normal ULN;

Suitable renal function: Cr≤normal ULN,or Ccr≥60 ml/min;

EKG normal;

Without healing wound;

No history of anti-cancer therapy, or adjuvant/neo-adjuvant chemotherapy for non-metastatic tumor finished for more than 6 months before enrollment;

For the female subject with productive ability, urine pregnancy test must be done and is negative within 7 days before enrollment;

No history of serious allergic to biologic agents, especially E.Coli products;

The authorized ICF must be signed.

Exclusion Criteria:

Woman in pregnancy and breast-feeding, or having productive ability without contraception;

Having the serious acute infection uncontrolled or purulent/chronic infection with unhealed wound;

Having the serious heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, valvular disease, and refractory hypertension;

Having uncontrolled nervous or mental disease with low compliance and reluctance to description of response; uncontrolled primary brain tumor or other metastatic brain cancer with obvious intracranial hypertension or mental symptoms;

Having the tendency of bleeding, such as FIB≤2G/L;

Being receiving adjuvant chemotherapy;

On other conditions investigator considers, the subject is not fitful to participate the trial.

Contacts and Locations

Locations

China, Guangdong

Affiliated Cancer Hospital & Institute of Guangzhou Medical University; Recruiting

Guangzhou, Guangdong, China, 510000

Contact: Chuan Jin, post-graduate 020-66673666 18302078099@163.com

Sponsors and Collaborators

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

More Information

• Responsible Party: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
• ClinicalTrials.gov Identifier: NCT03706703
• Other Study ID Numbers: ENDOSTAR
• First Posted: October 16, 2018
• Last Update Posted: October 17, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carboplatin; Docetaxel; Pemetrexed; Endostar protein; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors