Clinical trialPhase 2Completed
Phase II Study of Ibrutinib in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors
- Outcome
- Results posted; single-arm, no comparison
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 9 October 2015
- Ended
- 4 November 2019
- Enrollment
- 20 participants
- Sites
- 1
- Primary outcomes
- Overall Radiographic Response Rate (ORR)
- Sponsor type
- Academic / other
- Results posted
- 2 October 2019
- Last update
- 11 September 2020
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
Results
- Primary endpoint
- Results posted; single-arm, no comparisonAs posted on ClinicalTrials.gov ↗, registry record of 11 September 2020
- ORR
- Overall Radiographic Response Rate (ORR)Ibrutinib Therapy: 0 of 20Values: ParticipantsTime frame: Up to 18 monthsNo analysis posted for this outcome (outcome 1)
- Participants
- Ibrutinib Therapy: 20 started, 20 completed
- Serious adverse events
- Ibrutinib Therapy: 2 of 20Participants with at least one serious adverse event, of those at risk, as posted
4 secondary outcomes, the first 3 shown
- PFS · Progression Free Survival (PFS)
- Ibrutinib Therapy 3.0 (2.8 to 5.8), n=20 [median months, 95% Confidence Interval]
- OS · Overall Survival (OS)
- Ibrutinib Therapy 24.1 (16.5 to NA), n=20 [median months, 95% Confidence Interval]
- Occurrence of Possibly Related Adverse Events (AEs)
- Ibrutinib Therapy 19/20 [Participants]
Every value is copied from the trial’s results record at ClinicalTrials.gov. “Statistically significant” describes the posted test only: it does not say which group did better, and nothing here is read from a paper.
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Brief summary public domain (ClinicalTrials.gov)
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).
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Overall Radiographic Response Rate (ORR) [Up to 18 months]. Count Of Participants, Participants. Ibrutinib Therapy (n=20): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression Free Survival (PFS) [1 year]. Median, months (95% Confidence Interval). Ibrutinib Therapy (n=20): 3.0 (2.8 to 5.8).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) [Up to 24 months]. Median, months (95% Confidence Interval). Ibrutinib Therapy (n=20): 24.1 (16.5 to NA) [The high end of the range was not reached at time of analysis.].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Occurrence of Possibly Related Adverse Events (AEs) [Up to 18 months]. Count Of Participants, Participants. Ibrutinib Therapy (n=20): 19.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Duration of Response [Up to 18 months].