Advanced Digestive System Neuroendocrine Neoplasm Clinical Trial
Official title:
A Phase II Study of LEE011 (Ribociclib) in Patients With Advanced Neuroendocrine Tumors of Foregut Origin
This phase II trial studies how well ribociclib works in treating patients with neuroendocrine tumors of the foregut, which includes the thymus, lung, stomach, and pancreas, that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced tumors). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. To estimate the Response Evaluation Criteria in Solid Tumors (RECIST) (per version 1.1) objective response rate of LEE011 (ribociclib) among patients with advanced foregut neuroendocrine tumors (NETs). SECONDARY OBJECTIVES: I. To evaluate the progression free survival duration of LEE011 among patients with advanced foregut NETs. II. To evaluate the safety and tolerability of LEE011 in patients with advanced foregut NETs. III. To determine clinic benefit rate at 6 months (defined as complete response plus partial response plus stable disease) with LEE011 among patients with advanced foregut NETs. EXPLORATORY OBJECTIVES: I. To determine baseline molecular markers (mutations, deletions, and amplifications in multiple endocrine neoplasia [MEN]1, p27, p16 and cyclin D1 [CCND1]) in archival tumor that may predict clinical benefit at 6 months from LEE011. II. To determine potential mechanisms/markers of resistance. III. To determine early chromogranin and neuron specific enolase responses in patients with elevated levels at baseline. IV. To determine the pharmacodynamic changes including proliferation-related Ki-67 antigen (Ki-67) and phosphorylated retinoblastoma (pRb) upon treatment with LEE011 in patients with advanced foregut NETs. OUTLINE: Patients receive ribociclib orally (PO) once daily (QD) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03891784 -
Abemaciclib in Treating Patients With Advanced, Refractory, and Unresectable Digestive System Neuroendocrine Tumors
|
Phase 2 |