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

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 |
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- Progression-Free Survival (PFS) [ Time Frame: Time is from Baseline to first evidence of disease progression.Assessments are performed every 2 months ]
- Overall Survival (OS) [ Time Frame: Time is from Baseline to first evidence of disease progression. Assessments are performed every 2 months ]
- Objective Response Rate (ORR) [ Time Frame: Time is from Baseline to first evidence of disease progression. Assessments are performed every 2 months ]
- Disease Control Rate (DCR) [ Time Frame: Time is from Baseline to first evidence of disease progression. Assessments are performed every 2 months ]
- 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.
- Clinical Benefit Rate (CBR) [ Time Frame: Time is from Baseline to first evidence of disease progression. Assessments are performed every 2 months ]
- 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

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

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

Study Director: | Eisai Medical Services | Eisai Limited |
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 |