A Randomized, Open-Label Phase 2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults with relapsed, Recurrent, or Refractory Synovial Sarcoma.
- Conditions
- malignant tumour that arises arount the tissues of the joints10013361
- Registration Number
- NL-OMON55480
- Lead Sponsor
- Eli Lilly
- Brief Summary
Trial never started
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 1
- 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.
- 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
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the progression free survival in patients who are treated with<br /><br>ramucirumab in combination with gemcitabine and docetaxel compared with<br /><br>gemcitabine and docetaxel in pediatric and young adult patients with SS.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety and tolerability Serious adverse events, adverse events, laboratory<br /><br>assesments and vital signs<br /><br><br /><br>Efficacy evaluation by - Overall response rate, duration of response and<br /><br>complete response.<br /><br><br /><br>PK evaluation by - minimum and maximum concentration<br /><br><br /><br>Immunogenicity evaluation by - incidence of immunogenicity</p><br>