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Clinical Trials/EUCTR2018-004242-42-BE
EUCTR2018-004242-42-BEActive, 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.

Eli Lilly and Company0 sites34 target enrollmentStarted: April 6, 2021Last updated:
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Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
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 protocol.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 10
  • •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 a known hypersensitivity to ramucirumab, cyclophosphamide, vinorelbine or any of the excipients of the medicinal products.
  • •- Patients who have previously received any exposure to ramucirumab are not eligible.
  • •- Patients with CNS involvement are ineligible.

Investigators

Similar Trials

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Phase 1
A Study Evaluating Ramucirumab in Children and Young Adults with Desmoplastic Small Round Cell Tumor.
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A Study Evaluating Ramucirumab in Children and Young Adults with Desmoplastic Small Round Cell Tumor.
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A Study Evaluating Ramucirumab in Children and Young Adults with Desmoplastic Small Round Cell Tumor.Desmoplastic small round cell tumour (DSRCT)MedDRA version: 21.1Level: PTClassification code 10064581Term: Desmoplastic small round cell tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Active, not recruiting
Phase 1
A Study Evaluating Ramucirumab in Children and Young Adults with Desmoplastic Small Round Cell Tumor.Desmoplastic small round cell tumour (DSRCT)MedDRA version: 21.1 Level: PT Classification code 10064581 Term: Desmoplastic small round cell tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Active, not recruiting
Phase 1
A Study Evaluating Ramucirumab in Children and Young Adults with Desmoplastic Small Round Cell Tumor.Desmoplastic small round cell tumour (DSRCT)MedDRA version: 21.1Level: PTClassification code 10064581Term: Desmoplastic small round cell tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2018-004242-42-ITELI LILLY & COMPANY, LILLY CORPORATE CENTER34