Oncology Pipeline

For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. In 2019 Lilly created Loxo Oncology at Lilly, with the goal of rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating new medicines that work in early clinical development and will matter to patients.

Phase 2  | ENROLLING

CAMPFIRE; NCT04145349

Pediatric Cancer

VEGF Receptor-2 Antagonist


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*

NCT04145349
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 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.
Additional criteria apply.
Contact the Lilly Oncology Clinical Trial Navigation Service

Visit www.clinicaltrials.gov for more information on this trial.

The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.