A study to investigate the efficacy of ramucirumab in combination with dacarbazine in patients with progressive well-differentiated metastatic neuroendocrine tumors of the pancreas
EU CTIS ID: 2024-515045-42-00
What this study is testing
The aim of this study is to investigate whether ramucirumab in combination with dacarbacine has an effect on the disease-control in patients with progressive pancreatic neuroendocrine tumors
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - Histologically confirmed unresectable metastatic G1-G2 differentiated pancreatic neuroendocrine tumor (non-functional and functional NET) excluding neuroendocrine carcinomas - Age: 18-75 years - Measurable disease (RECIST 1.1) - Progressive disease under treatment with either non-DTIC-based chemotherapy, SSA analogues, everolimus or sunitinib. No prior therapy with DTIC or temozolomide. Prior TACE and SIRT allowed with a minimum of 3 months before study entry, prior PRRT with a minimum of 12 months before study entry - ECOG 0-1 - Life expectancy > 12 weeks - Adequate renal, hepatic, bone marrow and coagulation function - Sexually active patiens: postmenopausal, surgically sterile, or use of effective contraception (Pearl Index <1). Female patients of childbearing potential: negative serum pregnancy test within 7 days prior to first dose of protocol therapy. - Written informed consent
You likely can't join if
- - Pregnancy or lactation. - Secondary malignancy in patient's history with the exception of: disease-free period > 5 years before randomization or non-melanoma skin cancer or curatively treated cervical carcinoma in situ or other noninvasive in situ neoplasm. - Allergy against dacarbazine or ramucirumab - Current enrolment or participation within the last 4 weeks in a clinical drug trial - Any arterial thromboembolic events within 6 months prior to first dose of protocol therapy. Insufficient liver function - Uncontrolled or poorly-controlled hypertension (>160 mmHg systolic or > 100 mmHg diastolic for >4 weeks) despite standard medical management - Chronic antiplatelet therapy, once-daily aspirin use (maximum dose 325 mg/day) permitted - Grade 3-4 GI bleeding within 3 months prior to first dose of protocol therapy. - History of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant") during the 3 months prior to first dose of protocol therapy - Uncontrolled severe physical or mental disorders - Pathological condition present that carries a high risk of bleeding - History of gastrointestinal perforation/fistula (within 6 months of first dose of protocol therapy) or risk factors for perforation. - Major surgery within 28 days prior to first dose of protocol therapy, or minor surgery/subcutaneous venous access device placement within 7 days prior to first dose of protocol therapy. Elective or planned major surgery to be performed during the course of the clinical trial. - Serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to first dose of protocol therapy. - officially and/or legally accomodated persons
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.