VEGF Receptor-2 Antagonist
Ramucirumab
Phase
2
Not Enrolling
A Randomized, Open-Label Phase 1/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults With Relapsed, Recurrent, or Refractory Desmoplastic Small Round Cell Tumor*
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Key Inclusion Criteria
- If in the US, aged 12 months to 29 years. If in the EU, aged 36 months to 29 years and >11 kg at study entry
- Relapsed, recurrent, or refractory desmoplastic small round cell tumors
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Received at least one prior line of systemic treatment (including neoadjuvant/adjuvant chemotherapy), including approved therapies for which the patient is eligible
- Discontinued all previous treatments for cancer or investigational agents ≥7 days prior to study entry and recovered from select acute effects to grade ≤2 for alopecia and decreased tendon reflex, and to grade ≤1 for all other effects at the time of enrollment||
- Adequate hematologic and organ function for at least 7 days prior to first dose of study drug||
- Female participants of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to randomization. Male and female participants must agree to use highly effective contraception for the duration of the study and up to 3 months following the last dose of ramucirumab and vinorelbine, and 12 months following the last dose of cyclophosphamide
Key Exclusion Criteria
- Eligible for surgical resection at time of enrollment
- Active infections requiring therapy, including HIV or hepatitis A, B, or C
- Prior allogeneic bone marrow or solid organ transplant
- Major surgical, laparoscopic, or significant traumatic injury within 28 days prior to enrollment. Surgical or other wounds must be adequately healed prior to enrollment
- Evidence of active bleeding, a bleeding diathesis or vasculitis, or a history of significant (grade ≥3) bleeding event, hemoptysis or pulmonary hemorrhage, a DVT or PE requiring medical intervention, or esophageal varices within 3 months prior to enrollment
- History of central nervous system arterial/venous thromboembolic events, including transient ischemic attack or cerebrovascular accident within 6 months prior to study enrollment, myocardial infarction or unstable angina within the prior 6 months, New York Heart Association (NYHA) grade ≥2 congestive heart failure, serious and inadequately controlled cardiac arrhythmia, significant vascular disease, or clinically significant peripheral vascular disease
- History of fistula, gastrointestinal ulcer or perforation, or intra-abdominal abscess within 3 months of study enrollment
- History of hypertensive crisis or hypertensive encephalopathy within 6 months of study enrollment
- Known hypersensitivity to ramucirumab, cyclophosphamide, vinorelbine, or any of the excipients of the medicinal product
- Severe liver cirrhosis (Child-Pugh class B or worse), cirrhosis with a history of hepatic encephalopathy, clinically meaningful ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis, or history of hepatorenal syndrome
- Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection, Crohn's disease, ulcerative colitis, or chronic diarrhea
- Urinary outflow obstruction, grade 2 hematuria, or noninfectious cystitis at the time of screening
- Severe and/or uncontrolled concurrent medical disease or psychiatric illness/social situation that, in the opinion of the investigator, could cause unacceptable safety risks or compromise protocol compliance
- Prior treatment with/progression on combination cyclophosphamide and vinorelbine regimen; prior treatment with ramucirumab
*
This clinical trial is being conducted globally.
†
Ramucirumab is administered intravenously (IV).
‡
Cyclophosphamide is administered PO.
§
Vinorelbine is administered IV.
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Additional criteria apply.
