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Rh-Endostatin in Combination With Icotinib for Advanced NSCLC With EGFR Mutations

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ClinicalTrials.gov Identifier: NCT02375022
Recruitment Status : Unknown
Verified March 2015 by Qiong Zhao, Zhejiang University.
Recruitment status was:  Recruiting
First Posted : March 2, 2015
Last Update Posted : March 24, 2015
Sponsor:
Collaborators:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Beta Pharma, Inc.
Information provided by (Responsible Party):
Qiong Zhao, Zhejiang University

Tracking Information
First Submitted Date  ICMJE February 10, 2015
First Posted Date  ICMJE March 2, 2015
Last Update Posted Date March 24, 2015
Study Start Date  ICMJE March 2015
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2015)
Objective response rate [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2015)
  • Progression free survival [ Time Frame: 12 months ]
  • Safety: Number of Participants with Adverse Events [ Time Frame: 12 months ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rh-Endostatin in Combination With Icotinib for Advanced NSCLC With EGFR Mutations
Official Title  ICMJE A Study to Evaluate the Efficacy of Rh-Endostatin (Endostar®) in Combination With Icotinib for Advanced Non-Small Cell Lung Cancer With EGFR Mutations
Brief Summary This single-arm pilot study tries to invesitgate how well giving icotinib with rh-endostatin (Endostar®) works in treating patients with advanced stage non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations. Icotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Anti-angiogeneiss drug, such as rh-endostatin, can block tumor growth by inhibiting the ability of tumors to grow new blood vessels and spread. It is not yet known whether icotinib is more effective when given with rh-endostatin in NSCLC patients with EGFR activating mutations.
Detailed Description
  1. Open-label, single-arm, prospective pilot study.
  2. Definition of advanced non small cell lung cancer: stage IIIb or IV. EGFR mutation status: activating mutation (defined as deletion 19 or exon 21 L858R mutation).
  3. Before starting study treatment, computed tomography scans of the chest, B ultrasound of abdomen, 12-lead electrocardiogram, MRI scan of brain, and a bone scan are required.
  4. Tumor response, based on investigator-assessed Response Evaluation Criteria in Solid Tumors (RECIST v.1.1), will be evaluated every 6 weeks during treatment.
  5. Exploratory evaluation will be performed using dynamic contrast enhanced MRI (DCE-MRI).
  6. QoL will be assessed using the core module, which will be completed by patients at baseline and before each cycle during treatment.
  7. All patients who prematurely discontinue treatment for any reason will be followed for survival.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE Drug: Endostar and icotinib
Endostar and icotinib are used as combination therapy.
Other Names:
  • Recombinant Human Endostatin Injection
  • Icotinib Hydrochloride Tablets
Study Arms  ICMJE Experimental: Endostar and icotinib
Combination of drug: Endostar: 15mg CIV d1-9, Q3w and icotinib: 125mg TID po. If no progressive disease observed, combination treatment will continue until unacceptable toxicity or progressive disease.
Intervention: Drug: Endostar and icotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 27, 2015)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2016
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologic documentation of non small cell lung cancer, with activating epidermal growth factor receptor (defined as deletion 19 or exon 21 L858R mutation).
  • Stage IV disease according to the 7th Edition of the American Joint Committee on Cancer staging system -Measureable disease
  • Life expectancy of >= 12 months
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
  • Absolute neutrophil count (ANC) >= 1, 500/mm^3, platelet count >= 100,000/mm^3, hemoglobin >= 9.0 g/dL.
  • Total bilirubin =< 1.5 x upper limit of normal (ULN), serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x ULN in patients without liver or bone metastases; < 5 x ULN in patients with liver or bone metastases, cockcroft-Gault calculated creatinine clearance of >= 45 ml/min or creatinine =< 1.5 x ULN.
  • Prothrombin time (PT) =< 1.5 x ULN, partial thromboplastin time (PTT) =< ULN
  • Urine dipstick proteinuria < 2+. Patients discovered to have >= 2 + proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate < 1 g of protein in 24 hours.
  • Negative pregnancy test done =< 7 days prior to randomization, for women of childbearing potential only.
  • Provide informed written consent.
  • Willing to return to enrolling institution for follow-up.
  • Willing to provide tissue and blood samples for correlative research purposes.

Exclusion Criteria:

  • Evidence of bleeding diathesis or coagulopathy.
  • Evidence of central nervous system involvement or brain metastases confirmed by head CT or brain MRI within 28 days prior to being registered for protocol therapy.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration for protocol therapy.
  • Anticipation of need for major surgical procedure during the course of the study.
  • Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to registration for protocol therapy.
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to registration for protocol therapy.
  • Serious, non-healing wound, ulcer, or bone fracture.
  • History of hemoptysis.
  • Clinically significant infections as judged by the treating investigator.
  • Other active malignancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02375022
Other Study ID Numbers  ICMJE ZYTOP1501
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Qiong Zhao, Zhejiang University
Study Sponsor  ICMJE Zhejiang University
Collaborators  ICMJE
  • Jiangsu Simcere Pharmaceutical Co., Ltd.
  • Beta Pharma, Inc.
Investigators  ICMJE Not Provided
PRS Account Zhejiang University
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP