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

• Status: Completed
• Trial end date: 2017-02-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hutchison Medipharma Limited
• Collaborator: Shanghai Chest Hospital

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.