Clinical trialPhase 2Completed
Carfilzomib for the Treatment of Patients With Advanced Neuroendocrine Cancers
Phase II Study of Carfilzomib for the Treatment of Patients With Advanced Neuroendocrine Cancers
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 15 July 2015
- Expected end
- 15 May 2021
- Enrollment
- 62 participants
- Sites
- 10
- Primary outcomes
- Overall Response Rate (ORR)
- Sponsor
- Other
- Results posted
- 2022-07-01
- Last update
- 5 December 2023
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Brief summary public domain (ClinicalTrials.gov)
The purpose of this study is to determine if carfilzomib is safe and effective in the treatment of patients with advanced neuroendocrine tumors.
Detailed description public domain (ClinicalTrials.gov)
Neuroendocrine malignancies such as pancreatic neuroendocrine tumors (PNETs) and gastrointestinal (GI) carcinoids, are generally rare but their incidences are increasing. In vitro and in vivo studies have shown that proteasome inhibitors have activity against a variety of tumor types. Carfilzomib (Kyprolis®) is an irreversible proteasome inhibitor with a favorable safety profile that has been studied in a variety of hematologic and solid tumors. Carfilzomib received accelerated approval from the U.S. FDA in 2012, based on a favorable response rate, for the treatment of patients with multiple myeloma who received at least two prior therapies, and demonstrated disease progression within 60 days of completing the last therapy. In this multi-center study, the investigators propose to evaluate carfilzomib for the treatment of patients with advanced neuroendocrine cancers.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Overall Response Rate (ORR) [every 3 cycles (1 cycle= 28 days) until treatment discontinuation up to 4 years]. Number, percentage of participants (95% Confidence Interval). Carfilzomib (n=62): 3.226 (0.4 to 11.2).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Disease Control Rate (DCR) [every 3 cycles (1 cycle= 28 days) until treatment discontinuation up to 4 years]. Number, percentage of participants (95% Confidence Interval). Carfilzomib (n=62): 58 (44.8 to 70.5).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression Free Survival (PFS) [up to 4 years]. Median, months (95% Confidence Interval). Carfilzomib (n=62): 8 (2.9 to 11.1).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability [From the day of the first dose to 30 days after the last dose of study medication, up to 4 years]. Count Of Participants, Participants. Carfilzomib (n=62): 56.