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Clinical Trials/EUCTR2013-003595-12-CZ
EUCTR2013-003595-12-CZActive, not recruitingPhase 1

A Phase II Study of Pazopanib (GW786034, NSC# 737754) in Children, Adolescents and Young Adults with Refractory Solid Tumors

ovartis Pharma Services AG0 sites154 target enrollmentStarted: August 14, 2017Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
154
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • •Age: Patients must be at least 1 year and less than or equal to 18 years of age at the time of study entry.
  • •Diagnosis: Patients must have had histologic verification of one of the malignancies listed below at original diagnosis or at relapse.
  • •1.Rhabdomyosarcoma
  • •2.Non-rhabdomyosarcomatous Soft Tissue Sarcoma (including desmoplastic small round cell tumor)
  • •3.Ewing Sarcoma/Peripheral PNET
  • •4.Osteosarcoma
  • •5.Neuroblastoma (Measurable)
  • •6.Neuroblastoma (Evaluable)
  • •7.Hepatoblastoma
  • •Patient must have disease that has either relapsed or is refractory to prior therapy
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 154
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •Pregnant or breast-feeding women are not eligible for this study
  • •Concomitant Medications
  • •1.Corticosteroids: Patients requiring corticosteroid who have not been on a stable or decreasing dose of corticosteroid for the 7 days prior to enrollment are not eligible.
  • •2.Investigational Drugs: Patients who are currently receiving another investigational drug are not eligible.
  • •3.Anti-Cancer Agents or Radiation Therapy: Patients who are currently receiving other anti-cancer agents or radiation therapy are not eligible.
  • •4.Anti-hypertensive: Patients who are currently receiving more than one anti-hypertensive medication (Grade 3) or whose blood pressure is not controlled (i.e. as defined in Section 3.2.8.) are not eligible for study enrollment.
  • •5.Anti-coagulation: Patients must not be on therapeutic anticoagulation. ((Warfarin (coumadin®) and/or low molecular weight heparin are prohibited.) Prophylactic anticoagulation (ie intraluminal heparin) of venous or arterial access devices is allowed.
  • •6.CYP3A4 Substrates and drugs causing QTc prolongation: Patients receiving drugs with a known risk of torsades de pointes are not eligible. See Appendices IIIA and IIIB and Section 4.8 for a list of enzyme inducing, enzyme inhibiting and other adversely interacting drugs and the appropriate washout periods required prior to study enrollment
  • •Note: This list includes the prohibition of grapefruit juice for 14 days prior to enrollment and while receiving pazopanib.
  • •7.Thyroid Replacement Therapy: Patients who require thyroid replacement therapy are not eligible if they have not been receiving a stable replacement dose for at least 4 weeks prior to study enrollment
  • •Patients who are unable to swallow tablets or liquid are not eligible. Pazopanib cannot be administered via NG tube or G-tube

Investigators

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