BridgeMD
Tests treatment safety and results for Lung Neuroendocrine Neoplasm
Official title A Trial Evaluating the Activity and Safety of Combination Between Cabozantinib and Temozolomide in Lung and GEP-NENS Progressive After Everolimus, Sunitinib or PRRT (CABOTEM)
ClinicalTrials.gov ID: NCT04893785
What this study is testing
What is Cabozantinib and Temozolomide?
Cabozantinib and Temozolomide is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for lung neuroendocrine neoplasm.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The aim of CABOTEM study is to demonstrate the safety and activity of the Cabozantinib and Temozolomide combination in Lung and GEP-NENs patients, progressing after a first line therapy, including target therapies (everolimus, sunitinib) and / or chemotherapy, in the approved setting.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18 years and older patients.
- Signed informed consent prior to initiation of any study-specific procedures or treatment, as confirmation of the patient's awareness and willingness...
- Documented histological or cytological diagnosis of well differentiated Lung and GEP-NENs (NET G1, NET G2, NET G3 in WHO 2017 classification)...
- people must have evidence of progressed disease, radiologically documented in the 12 months previous study entry.
- people must have evidence of measurable disease as determined by the investigator. Target lesions must have shown evidence of disease progression by...
You likely can't join if
- Receipt of any type of anticancer therapy within 4 weeks before study entry.
- Previous treatment with Temozolomide or cabozantinib
- Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before recruitment.
- Previous PRRT treatment: Systemic treatment with radionuclides within 6 months before study entry.
- people with clinically relevant ongoing complications from prior radiation therapy and/or surgery are not eligible.
- Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before...
See the full eligibility criteria
- 18 years and older patients.
- Signed informed consent prior to initiation of any study-specific procedures or treatment, as confirmation of the patient's awareness and willingness to comply with the study requirements.
- Documented histological or cytological diagnosis of well differentiated Lung and GEP-NENs (NET G1, NET G2, NET G3 in WHO 2017 classification) progressing after a first line of therapy with SSAs, sunitinib, everolimus...
- people must have evidence of progressed disease, radiologically documented in the 12 months previous study entry.
- people must have evidence of measurable disease as determined by the investigator. Target lesions must have shown evidence of disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1...
- Subject must have adequate swallowing capacity.
- people with functional (associated with a clinical hormone syndrome) and non functional tumors are eligible for the study.
- The concurrent use of somatostatin analogues is allowed provided that the patient has been on a stable dose for at least two months.
- At least 4 weeks of wash-out from previous targeted therapies.
- At least 6 months of wash-out from previous PRRT treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
- people must have adequate organ function, including the following:
- Bone marrow reserve consistent with: absolute neutrophil count (ANC) ≥1.5 x109/L; platelet count ≥ 100 x 109/L; haemoglobin ≥ 9 g/dL;
- Hepatic: total bilirubin ≤ 1.5 x upper limit of normal (ULN), transaminases (aspartate aminotransferase/serum glutamic oxaloacetic transaminase [AST/SGOT] and alanine aminotransferase/serum glutamic pyruvic transaminase...
- Renal: normal serum creatinine or calculated creatinine clearance ≥ 60 mL/min (Cockroft-Gault formula);
- Recovery from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
- Estimated life expectancy of ≥12 weeks
- Sexually active fertile female people must agree to use effective contraceptive methods during the course of the study and for 4 months after the last dose of study treatment. While sexually active fertile male people...
- For women of child-bearing potential, negative serum pregnancy test within 14 days prior to the first study drug administration;
- Ability to understand and willingness to sign informed consent form prior to initiation of any study procedures and willingness to comply with the study requirements.
- Receipt of any type of anticancer therapy within 4 weeks before study entry.
- Previous treatment with Temozolomide or cabozantinib
- Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before recruitment.
- Previous PRRT treatment: Systemic treatment with radionuclides within 6 months before study entry.
- people with clinically relevant ongoing complications from prior radiation therapy and/or surgery are not eligible.
- Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before study entry
- Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors.
- Chronic hepatitis B infection (both active or not).
- Chronic treatment with corticosteroids or other immuno-suppressive agents.
- Serious illness other than cancer including, but not limited to, the following conditions:
- Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation: i.e. Tumors invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (eg, Crohn's...
- Cavitating pulmonary lesion(s) or endobronchial disease
- Lesion invading a major blood vessel including, but not limited to: inferior vena cava, pulmonary artery, or aorta. people with lesions invading the portal vasculature are eligible.
- Clinically significant bleeding risk including the following within 3 months of recruitment: hematuria, hematemesis, hemoptysis of \>0.5 teaspoon (\>2.5 mL) of red blood, or other signs indicative of pulmonary...
- Other clinically significant disorders such as: I. Active infection requiring systemic treatment, known infection with human immunodeficiency virus (HIV), or known acquired immunodeficiency syndrome (AIDS)-related...
- Uncontrolled congestive heart failure (NYHA II, III, IV). Patients with history of congestive heart failure who do not violate this exclusion criterion will undergo an evaluation of their cardiac ejection fraction prior...
- QTcF \> 470 msec for females and QTcF \> 450 msec for males or congenital long QT syndrome.
- Patients with rare hereditary problems of galattose intolerance, congenital lactase deficiency or glucose - galattose malabsorption.
- Major surgery within 3 months before study entry. Complete wound healing from major surgery must have occurred 1 month before study entry and from minor surgery at least 10 days before study entry.
- Pregnant or lactating females.
- History of another malignancy within 2 years before study entry, except for superficial skin cancers.
- Serious and/or unstable pre-existing medical or psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.
- Patients on chronic treatment with drugs that are contraindicated to with cabozantinib and temozolomide treatment according to the SmPC of each product.
The study team makes the final eligibility decision.
Where it's taking place
- Naples, Campania, Italy
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Naples, Campania, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.