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A Study Comparing the Combination of the Best Supportive Care Plus E7080 Versus Best Supportive Care Alone, in Patients With Advanced Lung Cancer or Lung Cancer That Has Spread, Who Have Been Previously Treated, Unsuccessfully, With at Least 2 Different Treatments

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01529112
First received: January 6, 2012
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to compare the overall survival of patients receiving E7080 + Best Supportive Care with those receiving placebo + Best Supportive Care.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Lenvatinib (E7080)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Oral E7080 in Addition to Best Supportive Care (BSC) Versus BSC Alone in Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Who Have Failed at Least Two Systemic Anticancer Regimens

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: 16.5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 6 month and 1-year survival rates [ Time Frame: 6 months, 1 year until disease progression or death ] [ Designated as safety issue: No ]
  • Progression-Free Survival (PFS) [ Time Frame: Every 8 weeks until disease progression or death ] [ Designated as safety issue: No ]
  • Overall response rate (ORR), response duration, and disease control rate [ Time Frame: Every 8 weeks until disease progression or death ] [ Designated as safety issue: No ]
    ORR is the proportion of patients with complete response [CR] or partial response [PR]. Response duration and disease control rate are defined as the proportion of patients with CR, PR, or stable disease [SD] for greater than or equal to 1


Estimated Enrollment: 135
Study Start Date: November 2011
Estimated Study Completion Date: July 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Lenvatinib (E7080)
A 24 mg oral daily dose, each day of a 28 day treatment cycle
Other Name: E7080, HOPE
Placebo Comparator: Arm 2 Drug: Lenvatinib (E7080)
A 24 mg oral daily dose, each day of a 28 day treatment cycle
Other Name: E7080, HOPE

Detailed Description:

This double-blind, placebo-controlled, multicenter, randomized Phase II study will consist of a 2-arm design, comparing E7080 + BSC (Arm 1) with placebo + BSC (Arm 2). Approximately 135 patients will be randomized 2:1 to receive either E7080 or placebo in a blinded manner.

Patients may continue to receive study treatment until progression, unacceptable toxicity, withdrawal of consent, or withdrawal by Investigator.

All patients will receive BSC. Patients will be randomized in a 2:1 ratio to receive either E7080 or placebo. Patients will be stratified according to Eastern Cooperative Oncology Group (ECOG) Performance Status (PS; 0 to 1 versus 2).

Patients will receive study treatment (E7080 or placebo) administered once daily, continuously, plus best supportive care until disease progression, unacceptable toxicity, withdrawal of consent, or withdrawal by Investigator.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Age greater than or equal to 18 years;
  2. Patients with histologically or cytologically confirmed non-squamous NSCLC with locally advanced or metastatic disease, who have failed at least 2 lines of systemic anticancer therapy for advanced or metastatic NSCLC (does not include adjuvant chemotherapy)In countries where erlotinib is approved and marketed for the treatment of NSCLC, patients must have received erlotinib treatment for their NSCLC. In countries where crizotinib is approved and marketed, patients must have received crizotinib treatment for NSCLC that is anaplastic lymphoma kinase (ALK)-positive;
  3. Patients must have at least 1 site of measurable disease by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1);
  4. ECOG PS of 0 to 2;
  5. Patients must have adequate renal function as evidenced by serum creatinine less than or equal to 1.5 X upper limit of normal (ULN) or calculated creatinine clearance greater than or equal to 30 mL/min per the Cockcroft and Gault formula;
  6. Blood pressure must be well-controlled (less than or equal to140/90 mm Hg at Screening) with or without antihypertensive medication. Patients must have no history of hypertensive crisis or hypertensive encephalopathy;
  7. Patients must have adequate bone marrow function as evidenced by absolute neutrophil count (ANC) greater than or equal to 1.5 X 109/L, hemoglobin greater than or equal to 9.0 g/dL, and platelet count greater than or equal to 100 X 109/L;
  8. Patients must have adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the ULN, and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 X ULN (in the case of liver metastases, less than or equal to 5 X ULN).
  9. Patients must have adequate coagulation system function as defined by prothrombin time/International normalized ratio (INR) less than or equal to 1.5 X ULN.
  10. Male or female patients of child-producing potential must agree to use double barrier contraception, oral contraceptives, or avoidance of pregnancy measures during the study and for 90 days after the last day of treatment;
  11. Females of childbearing potential must have a negative serum pregnancy test;
  12. Females may not be breastfeeding;
  13. Ability to understand and willingness to sign a written informed consent.

Exclusion Criteria

  1. Prior therapy with E7080 or other small molecule vascular endothelial growth factor inhibitors;
  2. Presence of brain metastases, unless the patient has received adequate treatment at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 4 weeks prior to randomization;
  3. Meningeal carcinomatosis;
  4. Received chemotherapy, targeted therapy, radiotherapy, surgery, or immunotherapy within the 21 days prior to commencing study treatment or have not recovered from all treatment-related toxicities to Grade less than or equal to 2, except for alopecia;
  5. Received treatment with another investigational agent within the 30 days prior to commencing study treatment or patients who have not recovered from side effects of an investigational drug to Grade less than or equal to 2, except for alopecia;
  6. Patients with proteinuria greater than 1+ on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Patients with 24-hour urine protein greater than or equal to 1 g/24 hours will be ineligible;
  7. Serious non-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury within the 28 days prior to commencing study treatment.
  8. Major surgery scheduled during the projected course of the study;
  9. History of bleeding diathesis or coagulopathy;
  10. Active hemoptysis (defined as bright red blood of 1/2 teaspoon or more) within the 30 days prior to study entry;
  11. Refractory nausea and vomiting, malabsorption, significant bowel resection, or any other medical condition that would preclude adequate absorption or result in the inability to take oral medication;
  12. Other malignancy within 3 years of randomization, with the exception of adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer, with no subsequent evidence of recurrence and/or malignancies diagnosed at a stage where definitive therapy results in near certain cures.
  13. Significant cardiovascular impairment (history of congestive heart failure New York Heart Association [NYHA] Class >II, unstable angina or myocardial infarction within the past 6 months, or serious cardiac arrhythmia);
  14. Any history of cerebral vascular accident (CVA), transient ischemic attack (TIA), or Grade greater than or equal to 2 peripheral vascular disease unless they have had no evidence of active disease for at least 6 months prior to randomization;
  15. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the 6 months prior to enrollment;
  16. Patients with organ allografts requiring immunosuppression;
  17. Known positive human immunodeficiency virus (HIV), known hepatitis B surface antigen, or hepatitis C positive;
  18. Hypersensitivity to E7080 or any of the excipients;
  19. Any history of or concomitant medical condition that, in the opinion of the Investigator, would compromise the patient's ability to safely complete the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529112

  Show 50 Study Locations
Sponsors and Collaborators
Eisai Inc.
Quintiles
Investigators
Study Director: Harish Dave PharmaBio Development Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01529112     History of Changes
Other Study ID Numbers: E7080-703
Study First Received: January 6, 2012
Last Updated: July 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Locally Advanced
Metastatic Non-Squamous Non-Small Cell Lung Cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014