Lenvatinib and Everolimus in Treating Patients With Advanced, Unresectable Carcinoid 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03950609|
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : March 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced Carcinoid Tumor Digestive System Neuroendocrine Neoplasm Multiple Endocrine Neoplasia Type 1 Neuroendocrine Neoplasm Unresectable Carcinoid Tumor||Drug: Everolimus Drug: Lenvatinib||Phase 2|
I. To estimate the Response Evaluation Criteria in Solid Tumors (RECIST) (per version 1.1) objective response rate of lenvatinib in combination with everolimus among patients with advanced carcinoid tumors.
I. To evaluate the progression free survival duration of lenvatinib in combination with everolimus among patients with advanced carcinoids.
II. To evaluate the safety and tolerability of lenvatinib in combination with everolimus among patients with advanced carcinoid tumors.
I. To determine clinic benefit rate at 6 months (defined as complete response plus partial response plus stable disease) with lenvatinib + everolimus among patients with advanced carcinoid tumors.
II. To determine early CgA and neuron-specific enolase (NSE) response rates.
Patients receive lenvatinib orally (PO) daily and everolimus PO daily on days 1-28. Treatments repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Lenvatinib in Combination With Everolimus in Patients With Advanced Carcinoid Tumors|
|Actual Study Start Date :||July 30, 2019|
|Estimated Primary Completion Date :||May 7, 2021|
|Estimated Study Completion Date :||May 7, 2021|
Experimental: Treatment (lenvatinib, everolimus)
Patients receive lenvatinib PO daily and everolimus PO daily on days 1-28. Treatments repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Radiographic response rate [ Time Frame: Up to 30 days after completion of study treatment ]Graded with Response Evaluation Criteria in Solid Tumors version 1.1
- Objective response rate [ Time Frame: Up to 30 days after completion of study treatment ]
- Progression-free survival [ Time Frame: Up to 30 days after completion of study treatment ]
- Incidence of adverse events [ Time Frame: Up to 30 days after completion of study treatment ]Toxicity evaluations will be conducted every 2 weeks for the first 2 cycles and every cycle thereafter. Toxicity will be monitored using the Bayesian approach.
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): NCT03950609
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Nageshwara V. Dasari 713-792-2828 firstname.lastname@example.org|
|Principal Investigator: Nageshwara V. Dasari|
|Principal Investigator:||Nageshwara V Dasari||M.D. Anderson Cancer Center|