Eribulin and Lenvatinib in Advanced Solid Tumors
|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: NCT02640508|
Recruitment Status : Active, not recruiting
First Posted : December 29, 2015
Last Update Posted : April 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cancer Solid Tumor||Drug: Eribulin Drug: Lenvatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS# 15-2139)|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
Experimental: Combination Eribulin and lenvatinib
Eribulin will be given on days 1 and 8. Lenvatinib will be given daily in each 28 day cycle.
Will be given by I.V. at 1.4 mg/m2 on day 1 and day 8.
Other Name: Halaven
Will be taken orally at 20-24 mg daily in each 21 day cycle.
Other Name: Lenvima
- Overall response rate of lenvatinib and eribulin [ Time Frame: The overall response rate will be assessed after two cycles of therapy (1 cycle = 3 weeks) until the date of first documentation of disease progression or death (whichever occurs first) over an average of 18 months. ]
- Lenvatinib and eribulin toxicities will be graded using NCI CTCAE version 4.03 [ Time Frame: Safety will be evaluated from the time of registration until 30 days after last dose of treatment, resolution of the related AE or death. ]
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): NCT02640508
|United States, Texas|
|Cancer Therapy and Research Center University of Texas Health Science Center San Antonio|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Virginia Kaklamani, MD||University of Texas Health Science Center San Antonio|