NL-OMON55480
Withdrawn
Phase 2
A Randomized, Open-Label Phase 2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults with relapsed, Recurrent, or Refractory Synovial Sarcoma. - J1S-MC-JV02
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Eli Lilly
- Enrollment
- 1
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial never started
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Patients with either relapsed, recurrent, or refractory SS., \- Patients must
- •be 36 months to \<\=29 years of age at the time of study enrolment., \- Patients
- •must have received at least one prior line of systemic treatment, have
- •measurable disease by RECIST 1\.1, and must not be eligible for surgical
- •resection at time of enrolment., \- Patients who have a Lansky (\<16 years of
- •age; Lansky et al. 1987\) or Karnofsky (\>\=16 years of age; Karnofsky et al. 1948\)
- •performance score, of at least 50\., \- Patient with adequate hematologic,
- •coagulation, liver, cardiac and renal function, and adequate blood pressure
- •(BP) control as per protocol.
Exclusion Criteria
- •\- Patients who have had allogeneic bone marrow or solid organ transplant are
- •excluded., \- Patients who have active infections requiring therapy., \- Patients
- •who have a history of fistula, gastrointestinal (GI) ulcer or perforation, or
- •intra\-abdominal abscess within 3 months of study enrolment are not eligible., \-
- •Patients with a bowel obstruction, extensive intestinal resection or history or
- •presence of inflammatory enteropathy or other GI pathology as per protocol. , \-
- •Patients with a history of hepatorenal syndrome., \- Patients with evidence of
- •active bleeding or a history of significant (\>\= Grade 3\) bleeding event, deep
- •vein thrombosis requiring medical, intervention (including pulmonary embolism),
- •hemoptysis or other signs of pulmonary haemorrhage, or esophageal varices
Outcomes
Primary Outcomes
Not specified
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