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Loxo@Lilly aims to create medicines that make life better for all those affected by cancer around the world. Bringing together the focus and spirit of a biotech with the scale, resources, and heritage of Lilly, our team is focused on rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating oncology medicines that unequivocally show early signs of clinical activity and will matter to patients.
CAMPFIRE; NCT04145700
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 Synovial Sarcoma*
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 synovial sarcoma
- 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) that contains ifosfamide and/or doxorubicin, or any approved therapies for which they are eligible
- Discontinued all previous treatments for cancer or investigational agents ≥7 days prior to study entry and recovered from the 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 6 months following the last dose of docetaxel and gemcitabine
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
- Nonhealing wound, unhealed or incompletely healed fracture, or a compound bone fracture at the time of enrollment
- Known hypersensitivity to ramucirumab, gemcitabine, docetaxel, or agents formulated with polysorbate 80
- 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
- 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 gemcitabine and docetaxel
Contact the Lilly Oncology Clinical Trial Navigation Service
Visit www.clinicaltrials.gov for more information on this trial.
Need additional information or have a question:
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.