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Clinical Trials/EUCTR2018-004242-42-IT
EUCTR2018-004242-42-ITActive, not recruitingPhase 1

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. - J1S-MC-JV01

ELI LILLY & COMPANY, LILLY CORPORATE CENTER0 sites34 target enrollmentStarted: June 18, 2021Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
34
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •- The washout-period after previous antibody therapy is defined as 4 half-lives after the last dose of the antibody
  • •- Pediatric and young adult patients will be enrolled, where the specific age requirement for each indication will be specified in the protocol addenda.
  • •- Patients must be >11 kg at the time of study enrollment.
  • •- Patients with relapsed, recurrent, or refractory DSRCT.
  • •- Patients must be 36 months to =29 years of age at the time of study enrollment.
  • •- Patients must:
  • •have measurable disease by RECIST 1.1
  • •have received at least one prior line of systemic treatment (including neoadjuvant and adjuvant chemotherapy). This prior treatment must
  • •include approved therapies for which they are eligible, unless the patient is not a suitable candidate for the approved therapy.
  • •not be eligible for surgical resection at time of enrollment.
  • •- 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, renal
  • •and bladder function, and adequate blood pressure (BP) control as per
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 20
  • •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 enrollment 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 enrollment 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 cyclophosphamide and vinorelbine regimen. (Patients who received combination as maintenance therapy, without progression, would be eligible.)
  • •- Patients with known hypersensitivity to ramucirumab, cyclophosphamide or vinorelbine.
  • •- Patients who have previously received any exposure to ramucirumab are not eligible.
  • •-Patients with CNS involvement are ineligible.

Investigators

Sponsor
ELI LILLY & COMPANY, LILLY CORPORATE CENTER

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