Phase II Study of Ibrutinib in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors
|ClinicalTrials.gov Identifier: NCT02575300|
Recruitment Status : Active, not recruiting
First Posted : October 14, 2015
Last Update Posted : April 25, 2019
This is a prospective phase II open-label trial, stratifying patients equally into two cohorts consisting of carcinoid tumors and pancreatic neuroendocrine tumors (pNETs). The purpose of this study is to test any good and bad effects of the study drug called Ibrutinib.
The study population will consist of adult patients with histologically confirmed low to intermediate grade NETs of the GI tract, lungs and unknown primary (carcinoid tumors) or pNETs. All patients must be confirmed to have advanced disease. The study will enroll up to 51 patients in two cohorts (30 carcinoid and 21 pNET patients).
|Condition or disease||Intervention/treatment||Phase|
|Carcinoid Tumors Pancreatic NET||Drug: Ibrutinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Ibrutinib in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors|
|Actual Study Start Date :||October 9, 2015|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2021|
Experimental: Ibrutinib Therapy
Ibrutinib Initial Dose 560 mg by mouth (PO) every day (QD)
Ibrutinib will be administered orally once daily and each cycle will be defined as 4 weeks duration. Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.
Other Name: IMBRUVICA®
- Overall Radiographic Response Rate (ORR) [ Time Frame: Up to 18 months ]
Response rate as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. For this study, measurable disease is defined as the presence of at least one measurable lesion.
Measurable lesions must be accurately measured in at least one dimension (longest diameter in the plane of measurement is to be recorded) with a minimum size of: 10 mm by CT scan (CT scan slice thickness no greater than 5 mm (when CT scans have slice thickness >5 mm, the minimum size should be twice the slice thickness); 10 mm caliper measurement by clinical exam (lesions which cannot be accurately measured with calipers should be recorded as non-measurable); 20 mm by chest X-ray.
Complete Response (CR): complete disappearance of all target lesions, confirmed by repeat assessments at no less than 4 weeks after the criteria for response are first met. Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameter.
- Progression Free Survival (PFS) [ Time Frame: 1 year ]Progression free survival at one year. PFS, determined as the time from administration of the initial dose of ibrutinib until objective tumor progression using RECIST, or death. Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm.
- Median Overall Survival (OS) [ Time Frame: Up to 18 months ]Median overall survival and overall survival at 1 year. OS, determined from the time of drug administration to death from any cause.
- Occurrence of Possibly Related Adverse Events (AEs) [ Time Frame: Up to 18 months ]Adverse events possibly related to study treatment with Ibrutinib. Safety and tolerability will be assessed according to the NIH/NCI Common Terminology Criteria for Adverse Events version 4 (CTCAE v4).
- Duration of Response [ Time Frame: Up to 18 months ]Duration of response, defined as time from first observation of an objective response which is subsequently confirmed, to first disease progression or death due to any cause.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02575300
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Jonathan Strosberg, M.D.||H. Lee Moffitt Cancer Center and Research Institute|