Study of an Investigational Drug, E7386 Plus Lenvatinib in People with Endometrial Cancer after Chemotherapy and Immunotherapy
Treatment
Treatment study for people with previously treated endometrial cancer
Clinicaltrials.gov identifier:NCT04008797
Study Contact Information:
For inquiries, please contact Eisai Inquiry Service:
This study is an , Phase 1b/2, study of the oral medication E7386 plus the oral medication lenvatinib in people with endometrial cancer who had disease progression with platinum-based chemotherapy and anti-PD-(L)1 .
The study’s goal is to determine the safety and effectiveness of the drug E7386 in combination with lenvatinib in participants with advanced or recurrent endometrial cancer that has progressed after platinum-based chemotherapy and anti-PD-(L)1 .
The key objectives are to:
- Find the best dose of E7386 when used with lenvatinib.
- See how much E7386 adds to the effectiveness of the drug combination.
- Compare the combination of E7386 plus lenvatinib against standard chemotherapy used for recurrent endometrial cancer.
This Study is Open To:
Some requirements for participation include the following:
- You must be an adult (18 years or older) who has advanced or recurrent endometrial cancer and must be willing to undergo a tumor biopsy.
- You must have previously received treatment for endometrial cancer with platinum-containing chemotherapy and (chemotherapy and could have been given together or separately).
- You should have no more than 3 prior lines of treatment (if you have had previous treatment with radiation or hormonal therapy, these will not be counted).
- You must have recovered from any side effects that were caused by your previous treatments for endometrial cancer (exceptions are made for hair loss and some cases of peripheral neuropathy).
- You must have adequately controlled blood pressure with or without antihypertensive medications.
- You must have adequate kidney, liver, and bone marrow function.
This Study is NOT Open To:
Some exclusions for this trial include the following:
- You have previously received treatment with lenvatinib or E7386.
- You have central nervous system (CNS) metastases that have not been previously treated.
- You are unable to take oral medication or have uncontrolled nausea, diarrhea, or vomiting.
- Certain bone conditions (eg. a fracture within 6 months prior to starting study treatment).
- You have had another cancer within the 2 years prior to starting study treatment.
- Please refer to clinicaltrials.gov for further details on the inclusion and exclusion criteria for Study 102.
Approximately 120 study participants will be to one of the following treatments:
- E7386 orally twice daily plus lenvatinib orally once daily
- Lenvatinib orally once daily
- Physician’s choice of chemotherapy (doxorubicin by intravenous injection every 3 weeks, or paclitaxel by intravenous injection weekly in a 3 weeks on/1 week off pattern)
The Dose Optimization part of the study involves the following:
- A Screening Period to determine your eligibility for the study. Consent to undergo a biopsy during screening is also required.
- A Treatment Period where you will receive your study treatment (treatment groups described above) and be carefully monitored for safety and changes to your disease. Treatment will continue until your disease gets worse, you have an unacceptable side effect, you change your mind and no longer wish to participate in the study, your physician determines that you should stop (eg. if they determine it is not safe or beneficial to continue treatment), or Eisai closes the study.
- A Follow-up Period where you will have a phone call every 3 months to assess your status.
Study procedures will include laboratory blood tests, urine analysis, vital signs, physical examinations, cardiac monitoring, scans to evaluate the extent of disease, bone scans to determine bone density.
Study Contact Information:
For inquiries, please contact Eisai Inquiry Service:
Locations:
Arkansas
City: Little Rock RECRUITING
Facility: UAMS
Contact Info:
California
City: La Jolla RECRUITING
Facility: University of California San Diego (UCSD) - Moores Cancer Center(All)
Contact Info:
No contact info provided
City: San Francisco RECRUITING
Facility: California Pacific Medical Center
Contact Info:
City: Walnut Creek RECRUITING
Facility: John Muir Clinical Research
Contact Info:
Colorado
City: Aurora RECRUITING
Facility: University of Colorado Cancer Center - Anschutz Medical Campus
Contact Info:
Florida
City: Miami RECRUITING
Facility: Uni. Of Miami- Sylvester Cancer Centre
Contact Info:
City: Sarasota RECRUITING
Facility: Florida Cancer Specialists - South
Contact Info:
City: West Palm Beach RECRUITING
Facility: Florida Cancer Specialists - East
Contact Info:
Louisiana
City: Covington RECRUITING
Facility: Women's Cancer Care - Covington, LA
Contact Info:
Mississippi
City: Jackson RECRUITING
Facility: University Of Mississippi Medical Center
Contact Info:
New York
City: New York RECRUITING
Facility: Perlmutter Cancer Center- NYU Langone Health
Contact Info:
No contact info provided
City: New York RECRUITING
Facility: Memorial Sloan Kettering Cancer Center
Contact Info:
City: The Bronx RECRUITING
Facility: Montefiore Medical Center (MMC) - Jack D. Weiler Hospital
Contact Info:
Ohio
City: Cleveland RECRUITING
Facility: MetroHealth Medical Center
Contact Info:
City: Sylvania RECRUITING
Facility: ProMedica Flower Hospital
Contact Info:
Oklahoma
City: Oklahoma City RECRUITING
Facility: University of Oklahoma Health Science Center
Contact Info:
South Carolina
City: Charleston RECRUITING
Facility: Medical University of South Carolina
Contact Info:
No contact info provided
South Dakota
City: Sioux Falls RECRUITING
Facility: Sanford Cancer Centre
Contact Info:
Tennessee
City: Nashville RECRUITING
Facility: Tennessee Oncology
Contact Info:
City: Nashville RECRUITING
Facility: Vanderbilt University Medical Center (VUMC) - Vanderbilt-Ingram Cancer Center (VICC) - Nashville
Contact Info:
Texas
City: Dallas RECRUITING
Facility: University of Texas Southwestern Medical
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City: Houston RECRUITING
Facility: MD Anderson Cancer Center
Contact Info:
Washington
City: Seattle RECRUITING
Facility: Fred Hutchinson/University of Washington Cancer Consortium
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Other Countries
Country: Canada
City: Montreal RECRUITING
Facility: CHUM, Unit for Innovative Therapies
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Country: Canada
City: Montreal RECRUITING
Facility: McGill University Health Centre
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Country: Canada
City: Toronto RECRUITING
Facility: Sunnybrook Research Institute
Contact Info:
Country: China
City: Beijing RECRUITING
Facility: Beijing Cancer Hospital
Contact Info:
Country: China
City: Beijing RECRUITING
Facility: Peking Union Medical College Hospital
Contact Info:
Country: China
City: Changchun RECRUITING
Facility: The First Bethune Hospital of Jilin University
Contact Info:
Country: China
City: Fuzhou RECRUITING
Facility: Fujian Provincial Cancer Hospital
Contact Info:
No contact info provided
Country: China
City: Guangzhou RECRUITING
Facility: Sun Yan-sen University Cancer Center
Contact Info:
Country: China
City: Guangzhou RECRUITING
Facility: Sun Yat-Sen Memrial Hospital, Sun Yat-Sen University
Contact Info:
Country: China
City: Jinan RECRUITING
Facility: Cancer Hospital of Shandong First Medical University
Contact Info:
Country: China
City: Kunming RECRUITING
Facility: Yunnan Cancer Hospital
Contact Info:
No contact info provided
Country: China
City: Shanghai RECRUITING
Facility: Fudan University Cancer Center
Contact Info:
No contact info provided
Country: China
City: Shanghai RECRUITING
Facility: The Tenth People's Hospital; Shanghai Tongji University
Contact Info:
No contact info provided
Country: China
City: Shenzhen RECRUITING
Facility: Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
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Country: China
City: Tianjin RECRUITING
Facility: Tianjin Cancer Hospital
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Country: China
City: Wenzhou RECRUITING
Facility: The First Affiliated Hospital of Wenzhou Medical University
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Country: Denmark
City: Odense RECRUITING
Facility: Odense University Hospital
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Country: France
City: Bordeaux RECRUITING
Facility: CHU Bordeaux
Contact Info:
Country: France
City: Brest RECRUITING
Facility: CHU Cavale Blanche
Contact Info:
No contact info provided
Country: France
City: Caen RECRUITING
Facility: Centre François Baclesse
Contact Info:
Country: France
City: Clermont-Ferrand RECRUITING
Facility: Centre Jean Perrin
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Country: France
City: Dijon RECRUITING
Facility: Centre Georges-François Leclerc
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Country: France
City: La Tronche RECRUITING
Facility: Grenoble University Hospital (Centre Hospitalier Universitaire Grenoble Alpes)
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Country: France
City: Lyon RECRUITING
Facility: Centre Léon Bérard
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Country: France
City: Nice RECRUITING
Facility: Centre Antoine Lacassagne
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Country: France
City: Paris RECRUITING
Facility: Institut Curie - Centre de Recherche
Contact Info:
No contact info provided
Country: France
City: Paris RECRUITING
Facility: AP-HP Université de Paris, Port Royal
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Country: France
City: Paris RECRUITING
Facility: Hopital Europeen Georges-Pompidou (HEGP)
Contact Info:
Country: France
City: Paris RECRUITING
Facility: Hopital de la Croix Saint-Simon
Contact Info:
Country: France
City: Poitiers RECRUITING
Facility: Centre Hospitalier Universitaire (CHU) de Poitiers
Contact Info:
No contact info provided
Country: France
City: Saint-Herblain RECRUITING
Facility: Insitute de Cancérologie de l'Ouest - Centre René Gauducheau
Contact Info:
Country: France
City: Strasbourg RECRUITING
Facility: ICANs
Contact Info:
Country: France
City: Villejuif RECRUITING
Facility: Gustave Roussy Institute (IGR)
Contact Info:
No contact info provided
Country: Italy
City: Ancona RECRUITING
Facility: Clinica Oncologica AOU (Azienda Ospedaliero Universitaria) delle Marche
Contact Info:
Country: Italy
City: Milan RECRUITING
Facility: Istituto Clinico Humanitas, Rozzano
Contact Info:
Country: Italy
City: Rome RECRUITING
Facility: Fondazione Policlinico Gemelli IRCCS
Contact Info:
Country: Japan
City: Akashi RECRUITING
Facility: Eisai site #13
Contact Info:
Country: Japan
City: Chuo-Ku RECRUITING
Facility: Eisai Trial Site #1
Contact Info:
Country: Japan
City: Kashiwa RECRUITING
Facility: Eisai Trial Site #2
Contact Info:
Country: Japan
City: Koto-ku RECRUITING
Facility: Eisai Trial Site #6
Contact Info:
Country: Japan
City: Kurume RECRUITING
Facility: Eisai Trial Site #7
Contact Info:
Country: Japan
City: Minato-ku RECRUITING
Facility: Eisai Site 15
Contact Info:
Country: Japan
City: Niigata RECRUITING
Facility: Eisai site #14
Contact Info:
Country: Japan
State: Aichi-ken
City: Nagoya RECRUITING
Facility: Eisai Trial Site #5
Contact Info:
No contact info provided
Country: Japan
State: Saitama
City: Hidaka RECRUITING
Facility: Eisai Trial Site #9
Contact Info:
No contact info provided
Country: Republic of Korea
City: Guro-gu RECRUITING
Facility: Korea University Guro Hospital
Contact Info:
Country: Republic of Korea
City: Ilsandong-gu RECRUITING
Facility: National Cancer Center
Contact Info:
Country: Republic of Korea
City: Jongno-gu RECRUITING
Facility: Seoul National University Hospital
Contact Info:
Country: Republic of Korea
City: Seocho-Gu RECRUITING
Facility: Seoul St. Mary's Hospital
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Country: Republic of Korea
City: Seodaemun RECRUITING
Facility: Severance Hospital (Yonsei University Medical Center)
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Country: Republic of Korea
City: Seoul RECRUITING
Facility: Samsung Medical Center
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Country: Republic of Korea
City: Songpa-Gu RECRUITING
Facility: Asan Medical Centre
Contact Info:
Country: Spain
City: Barcelona RECRUITING
Facility: Fundació Privada Institut d'Investigació Oncològica de Vall-Hebron (VHIO)
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Country: Spain
City: Coruna RECRUITING
Facility: University Hospital A Coruña
Contact Info:
Country: Spain
City: Jaén RECRUITING
Facility: Hospital Universitario de Jaén
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Country: Spain
City: Madrid RECRUITING
Facility: H. Clinico San Carlos
Contact Info:
Country: Spain
City: Madrid RECRUITING
Facility: Clínica Universidad de Navarra
Contact Info:
Country: Spain
City: Madrid RECRUITING
Facility: Hospital Universitario 12 de Octubre
Contact Info:
Country: Taiwan
City: Taichung RECRUITING
Facility: Taichung Veterans General Hospital
Contact Info:
No contact info provided
Treatment
Treatment study for people with previously treated endometrial cancer
Clinicaltrials.gov identifier:NCT04008797
Study Contact Information:
For inquiries, please contact Eisai Inquiry Service: