Lenvatinib for Neuroendocrine Tumors

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Michigan Health System, Ann Arbor, MI
Neuroendocrine Tumors+2 More
Lenvatinib - Drug
Eligibility
18+
Male
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of lenvatinib and pembrolizumab is safe and effective in treating patients with advanced solid tumors.

See full description

Eligible Conditions

  • Neuroendocrine Tumors
  • refractory, metastatic hormone-refractory Prostate cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Neuroendocrine Tumors

Study Objectives

This trial is evaluating whether Lenvatinib will improve 2 primary outcomes and 4 secondary outcomes in patients with Neuroendocrine Tumors. Measurement will happen over the course of 2 years.

2 years
Duration of Response (DoR)
Frequency and Severity of adverse events
Objective Response Rate (ORR)
Overall Survival (OS)
Radiologic Progression Free Survival (rPFS) for bone lesions
Radiologic Progression Free Survival (rPFS) for soft tissue lesions

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Neuroendocrine Tumors

Trial Design

1 Treatment Group

Study Treatment Arm
1 of 1
Experimental Treatment

This trial requires 50 total participants across 1 different treatment group

This trial involves a single treatment. Lenvatinib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Study Treatment ArmLenvatinib 20 mg Orally Day1-21 with Pembrolizumab 200 mg Intravenously (IV) over 30 minutes Day 1. Each cycle = 21 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Closest Location

University of Michigan Health System - Ann Arbor, MI

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Age ≥ 18 years at the time of consent.
You are eligible for the study if you are a female and have not had a prior history of breast cancer. show original
Small-cell or NEPC morphology (determined by the enrolling center) on the basis of tissue sample. show original
Prostate adenocarcinoma with greater than 50% IHC staining for neuroendocrine markers (e.g., chromogranin and synaptophysin).
Presence of visceral metastases or high volume disease (> 4 sites of metastases) with a PSA of ≤ 5. show original
Serum chromogranin A level ≥ 5× upper limit of normal (ULN) and/or serum neuron specific enolase (NSE) ≥ 2× ULN.
RBI deletions or mutations noted on genomic testing.
You have a trans-differentiated carcinoma or poorly-differentiated carcinoma. show original
Subject has adequate organ function as defined in the table below; all screening labs to be obtained within 10 days prior to Cycle 1 Day 1.

Patient Q&A Section

How many people get neuroendocrine tumors a year in the United States?

"About 50% more people get neuroendocrine cancers a year than get tumors of the non-neuroendocrine organs. In total, over 1,500 cases of neuroendocrine tumor will be diagnosed, mostly gastrointestinal lesions in women and men. The greatest risk of death from neuroendocrine cancer is for patients with small bowel or gastrinoma." - Anonymous Online Contributor

Unverified Answer

What are common treatments for neuroendocrine tumors?

"Neuroendocrine tumors typically can be treated by surgery, medication, radiotherapy or radioimmunotherapy if the tumor is well differentiated, resectable and locally advanced. Chemotherapy has become an alternative in patients with tumors in which more intensive surgical and medical management is not possible. Adjuvant radiotherapy can also improve survival, provided that the patient is well-selected. Finally, targeted treatments such as targeted therapies (such as sunitinib for GIST) or antiangiogenic agents (such as bevacizumab, aflibercept, sorafenib, sunitinib for GIST) are being utilized to treat metastatic or unresectable tumors." - Anonymous Online Contributor

Unverified Answer

What is neuroendocrine tumors?

"Neuroendocrine tumors arise from cells that line the nerves or the endocrine glands. They often produce hormones that regulate hormone signaling from other cells in the body. Neuroendocrine tumors may also arise from cells that do not line nerve or endocrine cells but are derived from these cells as they mature. Examples of neuroendocrine tumors are medullary thyroid carcinoma which arises from cells that line the lining of the thyroid follicle, and parathyroid adenoma which arises from parathyroid cells that line the parathyroid gland. They are the most common tumors in all cancers of the endocrine system." - Anonymous Online Contributor

Unverified Answer

What are the signs of neuroendocrine tumors?

"These patients with nonfunctional, well-differentiated NET in various organs are asymptomatic and are diagnosed by biopsy. Many patients suffer from severe headaches, and some may present with features suggestive of functional gastrointestinal or renal tumors or may suffer from anemia." - Anonymous Online Contributor

Unverified Answer

What causes neuroendocrine tumors?

"Neuroendocrine tumor type is influenced by patient sex, age, and location. In particular, the presence and type of co-existent endocrine disease, the age of patient at diagnosis, and local site can affect site-specific tumor behavior and prognosis." - Anonymous Online Contributor

Unverified Answer

Can neuroendocrine tumors be cured?

"Although rare, a subset of PNET have a remarkable potential for cure. In particular, patients with "intermediate" or "high-grade" type are at high risk. These patients require a full surgical staging procedure and, for high-grade patients, some chemotherapeutic adjuvant protocols." - Anonymous Online Contributor

Unverified Answer

How quickly does neuroendocrine tumors spread?

"These data reveal that neuroendocrine tumors typically spread to extrapancreatic sites. However, the sites to which tumors metastasize varies depending on particular tumor types and patients." - Anonymous Online Contributor

Unverified Answer

What is the latest research for neuroendocrine tumors?

"There's a lot of research on neuroendocrine tumors to support the research of medical professionals for treatment and prevention of neuroendocrine tumors. You can find the most recent research from [Power(http://www.withpower.com/clinictrials)] and [ScienceWatch"" - Anonymous Online Contributor

Unverified Answer

Has lenvatinib proven to be more effective than a placebo?

"In this first randomized phase III trial in this population, a 20% increase in median PFS was noted compared to a placebo with lenvatinib monotherapy. Median PFS, OS, and ORRs with lenvatinib were comparable to a placebo for patients with advanced NETs." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of neuroendocrine tumors?

"Although neuroendocrine tumors usually develop from endocrine cells, neuroendocrine tumors may alternatively arise de novo or persist as the neoplasm of a benign precursor cell; neuroendocrine tumor subtypes can arise de novo or develop from other neoplasms. Genetic and epigenetic alterations may play an important role in either de novo development or persistence of neuroendocrine tumors." - Anonymous Online Contributor

Unverified Answer

How does lenvatinib work?

"Lenvatinib has been shown to reduce or eliminate the expression of IGF1R, PDGFR-alpha, PDGFR-beta, and EGFR in cultured tumor cell lines. In mice, lenvatinib reduces tumor growth, causes regression of established tumors, lowers tumor vascularity, inhibits angiogenesis, and reduces intratumoral macrophage populations that are associated with angiogenesis. All of these findings suggest that lenvatinib may be effective for treating malignant tumors in humans regardless of the tumor subtype." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving lenvatinib?

"Lenvatinib is being evaluated in clinical trials for several different indications, and the drug's mode of action is similar to gandertsartan, in the sense that the drug inhibits VEGFR2." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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