Abemaciclib in Treating Patients With Advanced, Refractory, and Unresectable Digestive System Neu… (NCT03891784) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Abemaciclib in Treating Patients With Advanced, Refractory, and Unresectable Digestive System Neuroendocrine Tumors
United States20 participantsStarted 2019-10-31
Plain-language summary
This phase II trial studies how well abemaciclib works in treating patients with digestive system neuroendocrine tumors that have spread to other places in the body, do not respond to treatment, and cannot be removed by surgery. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed GEP NET, radiographically progressed on at least one line of standard therapy within the past 12 months
* Primary tumors may be in: pancreas, foregut (esophagus, stomach, duodenum), midgut (small intestine, appendix), hindgut (large intestine, rectum), or unknown origin
* Tumors may be functional (associated with clinical symptoms of hormone secretion) or non-functional
* Well-differentiated NET with low grade (Ki67 index \< 3% or mitotic index \< 2 mitoses/10 high power field \[HPF\]), intermediate grade (Ki67 index 3-20% or mitotic index 2-20 mitoses/10 HPF), or high grade (Ki67 21% to ≤ 55% of mitotic index 21-55% mitoses/10 HPF). In cases where pathology reports call out only a "high grade neuroendocrine carcinoma", such patients are eligible only if well differentiated status is confirmed by a board-certified pathologist AND Ki-67 is ≤ 55%
* Metastatic or locally advanced unresectable disease
* Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1
* Prior or concurrent therapy with somatostatin analogs (SSAs) is allowed. If concurrent therapy, dose must be stable for at least 2 months
* Patients with carcinoid syndrome must have symptoms controlled with stable doses of SSAs for at least 2 months
\* Telotristat is not allowed
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 t…
What they're measuring
1
Objective response rate (ORR)
Timeframe: Up to 1 year after completion of study treatment