Clinical trialPhase 2Completed
Regorafenib in Treating Patients With Advanced or Metastatic Neuroendocrine Tumors
Phase II Study of Single Agent Regorafenib in Patients With Advanced/Metastatic Neuroendocrine Tumors
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 16 August 2016
- Expected end
- 20 August 2020
- Enrollment
- 3 participants
- Sites
- 5
- Primary outcomes
- PFS
- Sponsor
- Other
- Results posted
- 2021-12-15
- Last update
- 15 December 2021
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Brief summary public domain (ClinicalTrials.gov)
This phase II trial studies regorafenib in treating patients with neuroendocrine tumors that have spread from the primary site (place where it started) to other places in the body. Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed description public domain (ClinicalTrials.gov)
PRIMARY OBJECTIVES: I. To assess progression-free survival (PFS) in advanced/metastatic in patients with carcinoid or pancreatic islet cell tumors. SECONDARY OBJECTIVES: I. To assess overall survival and response rate in advanced/metastatic poor prognosis in patients with carcinoid or pancreatic islet cell tumors. II. To assess the toxicity of patients treated with regorafenib. III. To explore markers of angiogenesis as they relate to outcome in carcinoid and pancreatic islet cell tumors. OUTLINE: Patients receive regorafenib orally (PO) once daily (QD) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
PFS [Time from start of treatment to time of progression or death on study whichever comes first, assessed at 6 months].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Tumor Response Rate, Evaluated Using the New International Criteria Proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [Up to 4 years].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival [From start of treatment until death due to any cause, assessed up to 4 years].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Incidence of Adverse Events, Assessed According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [Up to 4 years].