Ribociclib in Treating Patients With Advanced Neuroendocrine Tumors of Foregut Origin

Conditions

• Advanced Digestive System Neuroendocrine Neoplasm
• Duodenal Neuroendocrine Tumor G1
• Functional Pancreatic Neuroendocrine Tumor
• Gastric Neuroendocrine Tumor
• Intermediate Grade Lung Neuroendocrine Neoplasm
• Low Grade Lung Neuroendocrine Neoplasm
• Nonfunctional Pancreatic Neuroendocrine Tumor
• Thymus Neoplasm

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Pharmacological Study — OTHER
  Correlative studies
• Ribociclib — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Aug 25, 2015

Status verified

Oct 2020

Primary completion

Jun 5, 2019

Completion

Jun 5, 2019

Study Design

Enrollment

21 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (ribociclib)
  Patients receive ribociclib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Participants With Response Rate Per Response Evaluation Criteria in Solid Tumors Version 1.1 [ Time Frame: 3 years 10 months ]

Locations (1)

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