Nintedanib in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors (NCT02399215) | Clinical Trial Compass
CompletedPhase 2
Nintedanib in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors
United States32 participantsStarted 2015-05-15
Plain-language summary
This phase II trial studies how well nintedanib works in treating patients with neuroendocrine tumors that have spread from where they started to nearby tissue or lymph nodes (locally advanced) or have spread from the primary site (place where they started) to other places in the body (metastatic). Nintedanib may stop the growth of tumor cells by slowing or stopping a certain type of receptor called vascular endothelial growth factor receptor (VEGFR) from attaching to its target. This may stop the growth of neuroendocrine tumors by blocking the growth of new blood vessels necessary for tumor growth.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient must be on a stable dose of octreotide (Sandostatin®) long-acting release (LAR) or lanreotide for 3 months prior to study enrollment
* Patient must have histologically or cytologically confirmed well differentiated or moderately differentiated (low grade or intermediate grade) neuroendocrine tumor that is locally advanced or metastatic and not of pancreatic origin
* Measurable disease determined by computed tomography (CT) or magnetic resonance imaging (MRI)
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Life expectancy greater than 3 months
* Leukocytes \>= 3,000/uL
* Absolute neutrophil count \>= 1,500/uL
* Total bilirubin =\< 2 mg/dL
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 1.5 x upper limit of normal (ULN) and bilirubin =\< ULN for patients without liver metastases
* AST/ALT =\< 2.5 x ULN and bilirubin =\< ULN for patients with liver metastases
* Patients with Gilbert syndrome and bilirubin \< 2 x ULN and normal AST/ALT
* Creatinine =\< 1.5 mg/dl
* Prior treatment will be permitted including surgery (\>= 4 weeks), cytotoxic chemotherapy (maximum of 2 prior regimens); radiation, interferon, targeted growth factors (\>= 4 weeks); and prior treatment with octreotide, will be allowed
* Ability to swallow and retain oral medication
* Participants of child-bearing potential (both male and female) must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PFS
Timeframe: Time interval from initiation of therapy, to its cessation for documentation of PD or death, assessed up to 2 years