ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of E7080 Alone, and in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Renal Cell Carcinoma Following One Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01136733
Recruitment Status : Unknown
Verified August 2016 by Eisai Inc..
Recruitment status was:  Active, not recruiting
First Posted : June 3, 2010
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is an open-label, multicenter, Phase 1b/2 study of lenvatinib alone and in combination with everolimus in subjects with unresectable advanced or metastatic renal cell carcinoma following one prior VEGF-targeted treatment.

Condition or disease Intervention/treatment Phase
Metastatic Renal Cell Carcinoma Drug: Lenvatinib Drug: Everolimus Phase 1 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Phase 1b/2 Study of E7080 Alone, and in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Renal Cell Carcinoma Following One Prior VEGF-Targeted Treatment
Study Start Date : August 2010
Actual Primary Completion Date : June 2014
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Lenvatinib Drug: Lenvatinib
taken orally,once a day
Other Name: E7080
Experimental: Lenvatinib plus Everolimus Drug: Lenvatinib
taken orally,once a day
Other Name: E7080

Drug: Everolimus
orally once a day
Active Comparator: Everolimus Drug: Everolimus
orally once a day


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Phase 1b=Dose-limiting toxicity (DLT) [ Time Frame: first dose to first documentation of disease progression or death measured every 8 weeks, safety cycle 1 (days 1,8,15) subsequent cycles (days 1 and 15) ]
  2. Phase 1b= Maximally tolerated dose (MTD) [ Time Frame: first dose to first documentation of disease progression or death measured every 8 weeks, safety cycle 1 (days 1,8,15) subsequent cycles (days 1 and 15) ]
  3. Phase 1b= Recommended Phase 2 (RP2) dose [ Time Frame: first dose to first documentation of disease progression or death measured every 8 weeks, safety cycle 1 (days 1,8,15) subsequent cycles (days 1 and 15) ]
  4. Phase 2=Progression-free survival (PFS) [ Time Frame: first dose to first documentation of disease progression or death measured every 8 weeks, safety cycle 1 (days 1,8,15) subsequent cycles (days 1 and 15) ]

Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Time is from Baseline to first evidence of disease progression.Assessments are performed every 2 months ]
  2. Overall Survival (OS) [ Time Frame: Time is from Baseline to first evidence of disease progression. Assessments are performed every 2 months ]
  3. Objective Response Rate (ORR) [ Time Frame: Time is from Baseline to first evidence of disease progression. Assessments are performed every 2 months ]
  4. Disease Control Rate (DCR) [ Time Frame: Time is from Baseline to first evidence of disease progression. Assessments are performed every 2 months ]
  5. Durable Stable Disease (SD) [ Time Frame: Time is from Baseline to first evidence of disease progression. Assessments are performed every 2 months ]
    The portion of subjects whose best over all response is SD and the the duration of of SD >23 weeks.

  6. Clinical Benefit Rate (CBR) [ Time Frame: Time is from Baseline to first evidence of disease progression. Assessments are performed every 2 months ]
  7. Pharmacokinetic (PK) and pharmacodynamic (PD) profile. [ Time Frame: Time is from Baseline to first evidence of disease progression. Assessments are performed every 2 months ]
    Plasma concentrations of lenvatinib and whole blood concentrations of everolimus at Cycle 1 days 1 and 15, Cycle 2 day 1 Cycle 3 Day 1


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Select Inclusion Criteria:

  • Histologically confirmed diagnosis of renal cell carcinoma.
  • Phase 2: Histological or cytological confirmation of predominant clear cell RCC (original tissue diagnosis of RCC is acceptable).
  • Documented evidence of unresectable advanced or metastatic RCC. Phase 2: Radiographic evidence of disease progression according to modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
  • Phase 2: One prior vascular endothelial growth factor (VEGF)-targeted treatment (for example, but not limited to, sunitinib, sorafenib, pazopanib, bevacizumab, axitinib, vatalanib, AV951/tivozanib) for unresectable advanced or metastatic RCC.
  • Phase 2: Measurable disease meeting the following criteria: a.) at least 1 lesion of greater than or equal to 1.5 cm in the longest diameter for a non-lymph node or greater than or equal to 1.5 cm in the short axis diameter for a lymph node which is serially measurable according to Modified RECIST 1.1 using computerized tomography/magnetic resonance imaging (CT/MRI) or photography. Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than or equal to 150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the Screening Visit.

Select Exclusion Criteria:

Phase 1b or Phase 2 specific per below:

  • Phase 1b only: Subjects with untreated or unstable metastasis to the central nervous system (CNS) are excluded. Subjects who have completed local therapy and have discontinued the use of steroids for this indication at least 4 weeks prior to commencing treatment and in whom stability has been proven by at least 2 CT or MRI scans obtained at least 4 weeks apart are eligible for Phase 1b only. Phase 2 only: Subjects with CNS (e.g., brain or leptomeningeal) metastasis are excluded.
  • Phase 2 only: More than one prior VEGF-targeted treatment for unresectable advanced or metastatic RCC.

Phase 1b or Phase 2 specific per below:

  • Phase 1b only: Prior exposure to lenvatinib. Phase 2 only: Prior exposure to lenvatinib or mammalian target of rapamycin (mTOR) inhibitor.
  • Subjects should not have received any anti-cancer treatment within 21 days or any investigational agent within 30 days prior to the first dose of study drug and should have recovered from any toxicity related to previous anti-cancer treatment. Major surgery within 3 weeks prior to the first dose of study drug.
  • Subjects having greater than 1+ proteinuria on urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria.
  • Subjects with urine protein greater than or equal to 1 g/24-hour will be ineligible. Uncontrolled diabetes as defined by fasting serum glucose at 1.5 x ULN.
  • Phase 2 only: Active malignancy (except for renal cell carcinoma, melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 24 months.
  • Known intolerance to any of the study drugs (or any of the excipients) and/or known hypersensitivity to rapamycins (e.g., sirolimus, everolimus, temsirolimus) or any of the excipients.
  • Phase 1b only: Subjects who discontinued prior tyrosine kinase inhibitor due to toxicity will be ineligible.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01136733


  Show 37 Study Locations
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Eisai Medical Services Eisai Limited
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01136733     History of Changes
Other Study ID Numbers: E7080-G000-205
First Posted: June 3, 2010    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: August 2016

Keywords provided by Eisai Inc.:
Unresectable advanced or metastatic renal cell carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Lenvatinib
Everolimus
 Sirolimus
Endothelial Growth Factors
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Growth Substances