LEE011 in Neuroendocrine Tumors of Foregut Origin
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|ClinicalTrials.gov Identifier: NCT02420691|
Recruitment Status : Active, not recruiting
First Posted : April 20, 2015
Last Update Posted : September 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Cancer||Drug: LEE011||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of LEE011 (Ribociclib) in Patients With Advanced Neuroendocrine Tumors of Foregut Origin (CLEE011 XUS02T)|
|Actual Study Start Date :||August 2015|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2019|
Patients treated with LEE011 600 mg by mouth daily 3 weeks on/1 week off in 28 day cycles. Participants allowed to remain on study until disease progression or unacceptable toxicities
600 mg by mouth daily on Days 1 - 21 of a 28 day cycle.
- Overall Response of LEE011 in Participants With Foregut Neuroendocrine Tumors (NETs) [ Time Frame: After 3, 21 day cycles ]Overall response is best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Participant's response assignment depends on achievement of both measurement and confirmation criteria. Progressive disease (PD) defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Response and progression evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) (per version 1.1).
- Clinic Benefit Rate of LEE011 in Participants With Foregut Neuroendocrine Tumors (NETs) [ Time Frame: 6 months ]Clinic benefit rate defined as complete response plus partial response plus stable disease with LEE011 among patients with advanced foregut NETs. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
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): NCT02420691
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Nageshwara V. Dasari, MBBS||M.D. Anderson Cancer Center|