Clinical trial • Phase II • Oncology
Cabozantinib for Neuroendocrine neoplasia | Neuroendocrine tumor
Phase II trial of Cabozantinib for Neuroendocrine neoplasia | Neuroendocrine tumor. None/Not specified-controlled. 45 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Neuroendocrine neoplasia | Neuroendocrine tumor
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 31-07-2024
- First CTIS Authorization Date
- 30-08-2024
Trial design
None/Not specified-controlled Phase II trial across 12 sites in Germany, Austria.
- Comparator
- None/Not specified
- Target Sample Size
- 45
Eligibility
Recruits 45 No vulnerable population selected (isVulnerablePopulationSelected: false). Patients without legal capacity are explicitly excluded: "Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial". Written informed consent is required: "Written informed consent obtained according to international guidelines and local laws"; participants must be able to understand and comply with trial procedures. Minors are excluded by age criterion (aged ≥ 18 years)..
- Pregnancy Exclusion
- Current or planned pregnancy, nursing period
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected: false). Patients without legal capacity are explicitly excluded: "Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial". Written informed consent is required: "Written informed consent obtained according to international guidelines and local laws"; participants must be able to understand and comply with trial procedures. Minors are excluded by age criterion (aged ≥ 18 years).
Inclusion criteria
- {"criterion_text":"- Patients with histologically confirmed diagnosis of neuroendocrine neoplasia\n- Tumor proliferation rate has to be > Ki67 20% and ≤ Ki67 60% (local assessment)\n- Male, female, or diverse patients aged ≥ 18 years without upper age limit\n- Patients with upto four different antitumoral therapies\n- At least one measurable tumor lesion in CT or MRI scan\n- Newly diagnosed or progressive disease assessed per RECIST criteria 1.1\n- Patients must have a performance status of ECOG 0-2\n- Patients must have a life expectancy of more than 3 months\n- Hb> 9 g/dl\n- Platelets >80T/µl\n- White blood cells >3T/μL\n- Total bilirubin <3mg/dl\n- AST and ALT <4xN\n- Serum creatinine <2mg/dl, eGFR >40mL/min/1.73m2\n- BUN <5xN\n- Lipase <3xN\n- Albumin ≥2.8 g/dL\n- PT/PTT ≤ 1.5 × ULN\n- Urine protein:creatinine ration ≤ 1 (Note: if proteinuria < 2g/l and increased proteinuria is ruled out by an urine teststick the protein:creatinine ratio does not need to be determined)\n- Written informed consent obtained according to international guidelines and local laws\n- Ability to understand the nature of the trial and the trial related procedures and to comply with them"}
Exclusion criteria
- {"criterion_text":"- Patients with Mixed Neuroendocrine-Non-neuroendocrine Neoplasia (MINEN)\n- Patients with former treatment with TKI or VEGF receptor antagonist\n- Patients with additional malignancy <5 years in medical history (exclusion: non-invasive skin cancer)\n- Patients with symptomatic brain metastases\n- Patients with known HIV infection, acute and chronic-active hepatitis (type A, B or C) or another uncontrolled infection\n- Patients with known hypersensitivity to Cabozantinib or contraindications for treatment with Cabozantinib according to Summary of Product Characteristics (SmPC)\n- Patients with class III or IV congestive heart failure\n- Patients with prolonged QTc (for woman more than 470 ms, for men 450 ms)\n- Patients with uncontrolled hypertension (despite anti-hypertensive medication RR:>160/110 mmHg)\n- Patients with severely impaired lung function\n- Patients with history of organ transplant (exclusion: cornea transplantation)\n- Patients with clinical apparent acute or chronic gastric ulceration\n- Patients with history of hemophilia\n- Patients with surgery at the GI tract within the last 12 weeks\n- Patients with uncontrolled inflammatory bowel disease\n- Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed\n- Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial\n- Previous participation in this trial\n- Concomitant use of therapeutic anticoagulation or strong CYP3A4 inducers or inhibitors (e.g. amiodarone)\n- Known or persistent abuse of medication, drugs or alcohol\n- Person who is in a relationship of dependence/employment with the sponsor or the investigator\n- Current or planned pregnancy, nursing period"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Disease control rate (DCR) 6 months after treatment start (Complete Response (CR) + Partial Response (PR) + Stable Disease (SD))","definition_or_measurement_approach":"DCR at 6 months after treatment start defined as CR + PR + SD (measured per RECIST criteria 1.1 as implied elsewhere in the protocol)"}
Secondary endpoints
- {"endpoint_text":"- Disease control rate 3 and 12 months after treatment start","definition_or_measurement_approach":"DCR at 3 and 12 months after treatment start (CR + PR + SD), assessed over specified timepoints"}
- {"endpoint_text":"- Objective response rate (ORR) 3 months after treatment start and best objective response rate","definition_or_measurement_approach":"ORR at 3 months and best overall response (likely assessed per RECIST 1.1)"}
- {"endpoint_text":"- Progression free survival (PFS) and overall survival (OS)","definition_or_measurement_approach":"Time-to-event endpoints; PFS and OS measured using standard survival analysis methods (dates of progression and death)"}
- {"endpoint_text":"- Time on drug (TOD)","definition_or_measurement_approach":"Duration on study drug (from treatment start to discontinuation)"}
- {"endpoint_text":"- EORTC QLQ-C30 Quality of Life Questionnaire monthly for 12 months after treatment start and after 15 months","definition_or_measurement_approach":"QoL assessed with EORTC QLQ-C30 monthly for 12 months and at 15 months"}
- {"endpoint_text":"- Serious adverse events and adverse events, Data Safety Monitoring Board (DSMB)","definition_or_measurement_approach":"Safety endpoints: collection and reporting of adverse events and serious adverse events; oversight by DSMB"}
Recruitment
- Planned Sample Size
- 45
- Recruitment Window Months
- 51
- Consent Approach
- Written informed consent obtained according to international guidelines and local laws; adults (≥18 years) provide consent. Subject information and informed consent form documents are available (e.g. 'L1 PIC_G_for pub', 'L1_CABONEN_PIC_A_for pub' and pregnancy parts 'L1 PICpregPart_G_for pub', 'L1_CABONEN_PICpregPart_A_for pub'). No assent process described (minors excluded).
Geography
- Total Number Of Sites
- 12
- Total Number Of Participants
- 45
Germany
- Earliest CTIS Part Ii Submission Date
- 22-08-2024
- Latest Decision Or Authorization Date
- 30-08-2024
- Processing Time Days
- 8
- Number Of Sites
- 11
- Number Of Participants
- 40
Sites
- Site Name
- Zentralklinik Bad Berka GmbH
- Department Name
- Klinik für Innere Medizin/Gastroenterologie und Endokrinologie
- Contact Person Name
- Dieter Hörsch
- Contact Person Email
- dieter.hoersch@zentralklinik.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik für Gastroenterologie, Hepatologie, Infektiologie und Endokrinologie
- Contact Person Name
- Thomas Wirth
- Contact Person Email
- Wirth.Thomas@mh-hannover.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Medizinische Klinik I
- Contact Person Name
- Marianne Pavel
- Contact Person Email
- marianne.pavel@uk-erlangen.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- ENET, Medizinische Klinik II, Gastroenterologie
- Contact Person Name
- Alexander Weich
- Contact Person Email
- weich_a@ukw.de
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Gastroenterologie, Endokrinologie, Stoffwechsel und klinische Infektiologie
- Contact Person Name
- Michael Quante
- Contact Person Email
- michael.quante@uniklinik-freiburg.de
- Site Name
- Philipps-Universitaet Marburg
- Department Name
- Gastroenterologie, Endokrinologie, Stoffwechsel und klinische Infektiologie
- Contact Person Name
- Anja Rinke
- Contact Person Email
- gastro@med.uni-marburg.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Klinik für Medizinische Onkologie
- Contact Person Name
- Leonidas Apostolidis
- Contact Person Email
- leonidas.apostolidis@med.uni-heidelberg.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Medizinische Klinik I
- Contact Person Name
- Anke Kröcher
- Contact Person Email
- oncostudy@ukdd.de
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Klinik für Gastroenterologie, gastrointestinale Onkologie und Endokrinologie
- Contact Person Name
- Alexander König
- Contact Person Email
- christa.lichte-adelski@med.uni-goettingen.de
- Site Name
- Universitaetsklinikum Halle (Saale) AöR
- Department Name
- Klinik für Innere Medizin I, (Gastroenterologie, Pneumologie)
- Contact Person Name
- Jonas Rosendahl
- Contact Person Email
- jonas.rosendahl@uk-halle.de
- Site Name
- Universitaetsklinikum Mannheim GmbH
- Department Name
- Gastroenterologie, Hepatologie, Infektiologie, Ernährungsmedizin
- Contact Person Name
- Nadine Schulte
- Contact Person Email
- nadine.schulte@umm.de
Austria
- Earliest CTIS Part Ii Submission Date
- 22-08-2024
- Latest Decision Or Authorization Date
- 02-09-2024
- Processing Time Days
- 11
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Universitaet Wien
- Department Name
- Universitätsklinik f. Innere Medizin I
- Contact Person Name
- Markus Raderer
- Contact Person Email
- markus.raderer@meduniwien.ac.at
Sponsor
Primary sponsor
- Full Name
- Universitaetsmedizin Goettingen
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- CABOMETYX 20 mg film-coated tablets
- Active Substance
- Cabozantinib
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation present (EU marketing authorisation number listed)
- Dose Levels
- 20 mg
- Maximum Dose
- 20 mg
- Investigational Product Name
- CABOMETYX 40 mg film-coated tablets
- Active Substance
- Cabozantinib
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation present (EU marketing authorisation number listed)
- Dose Levels
- 40 mg
- Maximum Dose
- 40 mg
- Investigational Product Name
- CABOMETYX 60 mg film-coated tablets
- Active Substance
- Cabozantinib
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation present (EU marketing authorisation number listed)
- Dose Levels
- 60 mg
- Maximum Dose
- 60 mg
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