Combination Chemotherapy With Pazopanib in Children and Adolescents With Relapsed/Refractory Solid Tumors

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Samsung Medical Center

Status and phase

Not yet enrolling
Phase 2
Phase 1

Conditions

Refractory Pediatric Solid Tumor
Relapsed Pediatric Solid Tumor

Treatments

Drug: Carboplatin
Drug: Pazopanib
Drug: Etoposide
Drug: Ifosfamide

Study type

Interventional

Funder types

Other

Identifiers

NCT03628131
2017-11-147

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of combination chemotherapy with Pazopanib in pediatric patients with relapsed/refractory solid tumor

Enrollment

46 estimated patients

Sex

All

Ages

2 to 22 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with refractory/relapsed solid tumor (Stable or progressive disease after 1st-line treatment or relapse)
  • Patients previously enrolled to "Genomic diagnosis of pediatric tumors by NGS (IRB No. SMC 2015-11-053)"

Exclusion criteria

  • Patients who had high-dose chemotherapy and autologous stem cell transplantation previously
  • Patients with organ dysfunction as follows (creatinine elevation ≥ 1.5 x upper limit of normal (ULN), ejection fraction <40%, significant arrhythmia or conduction disturbance)
  • Patients who are not eligible to have scheduled treatment due to the other significant impaired organ function
  • Patients with active bleeding
  • Patients who are taking strong CYP3A4 inhibitors, QTc-prolonging drugs, antithrombotic agents, or anti-platelet agents
  • Pregnant or nursing women
  • Patients who can not swallow the pill

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

46 participants in 1 patient group

Pazopanib + conventional chemotherapy
Experimental group
Description:
Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
Treatment:
Drug: Ifosfamide
Drug: Etoposide
Drug: Carboplatin
Drug: Pazopanib

Trial contacts and locations

1

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Central trial contact

Ki Woong Sung, MD, PhD

Data sourced from clinicaltrials.gov

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