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A Clinical Trial of Fruquintinib in Patients With Advanced Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT02590965
Recruitment Status : Completed
First Posted : October 29, 2015
Last Update Posted : February 23, 2018
Sponsor:
Collaborator:
Shanghai Chest Hospital
Information provided by (Responsible Party):
Hutchison Medipharma Limited

Brief Summary:
This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial to evaluate the efficacy and safety of Fruquintinib plus best supportive care in patients with advanced non-squamous non-small cell lung cancer who failed to second-line standard chemotherapy.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Fruquintinib Drug: Placebo Phase 2

Detailed Description:

Approximately 90 subjects will be randomized to Fruquintinib plus best supportive care or placebo plus best supportive care at a 2:1 ratio.

Randomization will be stratified by EGFR (epidermal growth factor receptor) gene status: mutant vs. wild type vs. unknown.

All subjects will receive Fruquintinib/placebo for consecutive 3 weeks, followed by one-week rest. A treatment cycle consists of 4 weeks. Tumor assessment will be performed every 4 weeks in the first 3 cycles, and every 8 weeks since the 4th cycle, until disease progression. Further treatment and survival follow-up after progression will be recorded.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multi-center Phase II Clinical Trial to Evaluate the Efficacy and Safety of Fruquintinib Plus Best Supportive Care in Patients With Advanced Non-squamous Non-small Cell Lung Cancer
Actual Study Start Date : May 29, 2014
Actual Primary Completion Date : August 7, 2015
Actual Study Completion Date : February 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Placebo Comparator: Control Group
Placebo is a capsule in the form of 1mg and 5 mg, orally, once daily, 3 weeks on/1week off with best supportive care.
Drug: Placebo
Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/1 week off
Other Name: HMPL-013-placebo

Experimental: Treatment Group
The subjects will receive oral Fruquintinib at fasting state 5mg+best supportive care, once daily for the first 3 consecutive weeks and dose holiday for 1 week according to their dose regimens until the occurrence of disease progression, unacceptable toxicity, or withdrawal of consent
Drug: Fruquintinib
After checking eligibility criteria, subjects will be randomized into Fruquintinib plus best supportive care group (treatment group) or placebo plus best supportive care group (control group) in a ration of 2:1.
Other Name: HMPL-013




Primary Outcome Measures :
  1. Progressive free survival (PFS) [ Time Frame: measured every 4 weeks at first 2 cycles and every 8 weeks since the third cycle from randomization to disease progression, assessed up to one year ]
    To compare the Progressive Free Survival (PFS) of Fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients advanced non-squamous NSCLC patients who failed to standard second-line chemotherapy according to RECIST 1.1


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: measured every 4 weeks at first 2 cycles and every 8 weeks since the third cycle from randomization to disease progression, assessed up to one year ]
    To evaluate objective response rate (ORR) in the two groups according to RECIST 1.1

  2. Disease control rate (DCR) [ Time Frame: measured every 4 weeks at first 2 cycles and every 8 weeks since the third cycle from randomization to disease progression, assessed up to one year ]
    To evaluate disease control rate (DCR) in the two groups according to RECIST 1.1

  3. Overall survival (OS) [ Time Frame: every 2 months from randomization to death, assessed up to one year ]
    To evaluate overall survival (OS) in the two groups

  4. safety and tolerability by incidence, severity and outcome of adverse events [ Time Frame: From randomization to 30 days after last dose ]
    To evaluate the safety and tolerability in the two groups by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 4.0.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Fully understand the study and sign the informed consent form voluntarily;
  2. Histologically and/or cytologically diagnosed with local advanced and/or metastatic stage IIIB/IV non-squamous NSCLC;
  3. Previously failed to two chemotherapy regimens(treatment failure is defined as disease progression or intolerable toxicity), patients with positive EGFR mutation permitted to treated by EGFR-TKI previously; patients with EGFR wild type or unknown whether or not treated by EGFR-TKI previously;
  4. Aged 18-75 years (inclusive);
  5. Body weight ≥40 kg;
  6. Evident measurable lesion(s) (according to RECIST1.1);
  7. ECOG Performance Status 0-1;
  8. Expected survival >12 weeks

Exclusion Criteria:

  1. Treatment in another clinical trials in the past 3 weeks; or treatment with systemic anti-tumor chemotherapy, radiotherapy or biotherapy within 3 weeks prior to administration of the study drug;
  2. Previous therapy with VEGF/VEGFR inhibitors;
  3. Unrecovered from toxicity caused by previous anti-cancer treatment (CTCAE >grade 1), or not completely recovered from previous surgery;
  4. Previous active brain metastasis (without radiotherapy previously, or symptoms stable < 4 weeks, or with clinical symptoms, or with medication to control symptoms);
  5. Other malignancies except basal cell carcinoma or cervical carcinoma in situ in the past 5 years;
  6. Uncontrolled clinical active infection, e.g. acute pneumonia and active hepatitis B;
  7. Dysphagia or known drug malabsorption;
  8. Present active duodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases or other conditions that may lead to gastrointestinal bleeding or perforation according to the investigators' judgment; or with a history of intestinal perforation or intestinal fistula;
  9. Have evidence or a history of thrombosis or bleeding tendency, regardless of seriousness;
  10. Stroke and/or transient ischemic attack within 12 months prior to enrollment;
  11. Appropriate organ function. Patients with any of the following conditions will be excluded:

    • Absolute neutrophil count (ANC) <1.5×109/L, platelet <100×109/L or hemoglobin <9 g/dL within 1 week prior to enrollment;
    • Serum total bilirubin >1.5 upper limit of normal (ULN), alanine transaminase and aspartate transferase >1.5×ULN; ALT and AST > 3×ULN in patients with liver metastasis;
    • Electrolyte abnormality of clinical significance;
    • Blood creatinine >ULN and creatinine clearance <60 ml/min;
    • Urine protein 2+ or above, or 24 h urine protein quantification ≥1.0 g/24 h;
    • Activated partial thromboplastin time (APTT) or/and INR and prothrombin time (PT) >1.5×ULN (according to reference range in each clinical study center);
  12. Uncontrolled hypertension, systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg with medication; or heart failure NYHA classification ≥ grade 2;
  13. Heart function evaluation: left ventricular ejection fraction <50% (echocardiography);
  14. Acute myocardial infarction, severe/unstable angina or coronary bypass surgery within 6 months prior to enrollment; history of arterial thrombosis or deep venous thrombosis;
  15. Skin wound, surgical site, wound site, severe mucosal ulcer or fracture without complete healing;
  16. Female subjects who are pregnant or lactating or of child bearing potential with positive pregnancy test result before the first dose;
  17. Patients with child bearing potential who or whose sexual partners are not willing to take contraceptive measures;
  18. Any clinical or laboratory abnormalities unfit to participate in this clinical trial according to the investigator's judgment;
  19. Serious psychological or psychiatric disorders which may affect subject compliance in this clinical study;
  20. Allergy to Fruquintinib and/or excipient contained in trial drugs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02590965


Locations
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China, Beijing
307 Hospital of PLA
Beijing, Beijing, China, 100071
Beijing Cancer Hospital
Beijing, Beijing, China, 100142
Beijing Chest Hospital
Beijing, Beijing, China, 101149
China, Chongqing
Xi Nan Hospital, Third Military Medical University
Chongqing, Chongqing, China, 400038
China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
China, Jiangsu
Nantong Tumor Hospital
Nantong, Jiangsu, China, 226000
China, Jilin
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
China, Shandong
Linyi Tumor Hospital
Linyi, Shandong, China, 276001
China, Shanghai
The Cancer Hospital of Fudan University
Shanghai, Shanghai, China, 200000
Shanghai Chest Hospital
Shanghai, Shanghai, China, 200030
China, Sichuan
West China Hospital
Chengdu, Sichuan, China, 610041
China, Zhejiang
The First Affiliated Hosptial of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Sponsors and Collaborators
Hutchison Medipharma Limited
Shanghai Chest Hospital
Investigators
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Study Director: Ye Hua, MD Huchison Medipharma Limited

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT02590965     History of Changes
Other Study ID Numbers: 2014-013-00CH1
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms