A Study Evaluating Ramucirumab in Children and Young Adults with Synovial Sarcoma.

Phase 1

• Conditions: Synovial Sarcoma; MedDRA version: 20.0Level: PTClassification code 10042863Term: Synovial sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-004243-23-FR
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-15
• Last Update Posted: 17 May 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

- Patients with either relapsed, recurrent, or refractory SS.
- Patients must be 12 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 within 3 months of enrollment are not eligible.
- Patients with a bleeding diathesis or vasculitis are not eligible.
- Patients with a history of central nervous system (CNS) arterial/venous thromboembolic events (VTEs) including transient ischemic attack (TIA) or cerebrovascular accident (CVA) within 6 months of study enrolment are not eligible.
- Patients with myocardial infarction or unstable angina within the prior 6 months.
- Patients with significant vascular disease or peripheral vascular disease.
- Patients with a history of hypertensive crisis or hypertensive encephalopathy within 6 months of study enrolment are not eligible.
- Patients who have non-healing wound, unhealed or incompletely healed fracture, or a compound (open) bone fracture at the time of
enrolment are not eligible.
- Patients previously treated and progressed on combination gemcitabine or docetaxel. (Patients who received combination as maintenance therapy, without progression, would be eligible.)
- Patients with a known hypersensitivity to gemcitabine, docetaxel or agents formulated with Polysorbate 80.
- Patients who have previously received any exposure to ramucirumab are not eligible.
- Patients with clinical or radiologic findings consistent with interstitial pneumonia or pulmonary fibrosis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified