A Trial of Cabozantinib in Patients With Advanced, Low Proliferative NEN G3

NCT04524208 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 02679
• Study Type: interventional
• Target: 45
• Locations: 2 countries
• Sites: 15

Brief Summary

The main objective of this clinical trial represents the evaluation of efficacy of the tyrosine kinase inhibitor Cabozantinib in patients with NEN G3 with a proliferation rate of Ki67 20 - 60%.

Conditions

Neuroendocrine Tumors; Neuroendocrine Carcinoma

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy of Cabozantinib treatment via DCR after 6 months.

  Disease control rate (DCR) 6 months after treatment start .

  6 months

Secondary Outcomes (6)

• Evaluate short- and long term efficacy of Cabozantinib treatment via DCR.

  12 months

• Evaluate short- and long term efficacy of Cabozantinib treatment via ORR.

  12 months

• Evaluate short- and long term efficacy of Cabozantinib treatment via PFS.

  24 months

• Evaluate short- and long term efficacy of Cabozantinib treatment via OS.

  24 months

• Evaluate exposure time.

  12 months

Other Outcomes (1)

• Safety of Cabozantinib via AE and SAE assessment.

  24 months

Study Arms (1)

Treatment-Arm

EXPERIMENTAL

Drug: Cabozantinib

Interventions

Cabozantinib DRUG

Cabozantinib is administered orally at the dose of 60 mg per day..

Treatment-Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with histologically confirmed diagnosis of neuroendocrine neoplasia;
• Tumor proliferation rate has to be between Ki67 20% to 60% (local assessment);
• Male, female, or diverse patients aged \> 18 years without upper age limit;
• At least one measurable tumor lesions in CT or MRI scan;
• Newly diagnosed or progressive disease assessed per RECIST criteria 1.1;
• Patients must have a performance status of ECOG 0-2;
• Patients must have a life expectancy of more than 3 months;
• Hb\> 9 mg/dl;
• platelets \>80T/µl;
• white blood cells \>3T/μL;
• total bilirubin \<3mg/dl;
• AST and ALT \<4xN;
• Serum creatinine \<2mg/dl, eGFR \>40mL/min/1.73m2;
• BUN \<5xN;
• lipase \<3xN;

You may not qualify if:

• Patients younger than 18 years;
• Patients with Mixed Neuroendocrine-Non-neuroendocrine Neoplasia (MINEN);
• Patients with former treatment with TKI or VEGF receptor antagonist;
• Patients with symptomatic brain metastases;
• Patients with Known HIV infection, infectious hepatitis (type A, B or C) or another uncontrolled infection;
• Patients with Known hypersensitivity to Cabozantinib or contraindications for treatment with Cabozantinib according to Summary of Product Characteristics (SmPC);
• Patients with class III or IV congestive heart failure;
• Patients with QTc more than 500 ms or 140% of normal range according to age;
• Patients with uncontrolled hypertension;
• Patients with severely impaired lung function;
• Patients with clinical apparent acute or chronic gastric ulceration;
• Patients with history of hemophilia;
• Patients with surgery at the GI tract within the last 12 weeks;
• Patients with patients with uncontrolled inflammatory bowel disease;
• Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed

Sponsors & Collaborators

• Karsten Gavenis: lead

Study Sites (15)

Medizinische Universität Wien

Vienna, Austria

Location

University Medical Center Göttingen

Göttingen, Lower Saxony, 37075, Germany

Location

Zentralklinik Bad Berka GmbH

Bad Berka, 99437, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

Universitätsklinikum Erlangen

Erlangen, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitätsklinikum Halle

Halle, Germany

Location

Asklepios St. Georg

Hamburg, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Klinikum Heidelberg

Heidelberg, Germany

Location

Universitätsmedizin Mannheim

Mannheim, Germany

Location

Universitätsklinikum Gießen und Marburg GmbH

Marburg, 35043, Germany

Location

Johannes-Wesling-Klinikum Minden

Minden, Germany

Location

Klinikum Ulm

Ulm, Germany

Location

Universitätsklinik Würzburg

Würzburg, Germany

Location

MeSH Terms

Conditions

Neuroendocrine Tumors; Carcinoma, Neuroendocrine

Interventions

cabozantinib

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

Study Officials

• Alexander König, PD Dr.

  University Medical Center Göttingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Project Manager

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 24, 2020
• Study Start: March 1, 2021
• Primary Completion: September 30, 2024
• Study Completion: October 31, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (14); AU (1)