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

NCT ID: NCT03628131

Last Updated: 2018-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-31

Study Completion Date

2025-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Relapsed Pediatric Solid Tumor Refractory Pediatric Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pazopanib + conventional chemotherapy

Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib

Group Type EXPERIMENTAL

Pazopanib

Intervention Type DRUG

Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib

Ifosfamide

Intervention Type DRUG

Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib

Carboplatin

Intervention Type DRUG

Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib

Etoposide

Intervention Type DRUG

Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib

Interventions

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Pazopanib

Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib

Intervention Type DRUG

Ifosfamide

Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib

Intervention Type DRUG

Carboplatin

Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib

Intervention Type DRUG

Etoposide

Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Republic of Korea

OTHER_GOV

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ki Woong Sung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Ki Woong Sung, MD, PhD

Role: CONTACT

82-2-3410-3529

Facility Contacts

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Ki Woong Sung

Role: primary

82-2-3410-3529

Other Identifiers

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2017-11-147

Identifier Type: -

Identifier Source: org_study_id

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