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

NCT03628131 | Unknown Phase 1

• 1 other identifier: 2017-11-147
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Relapsed Pediatric Solid Tumor; Refractory Pediatric Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of Pazopanib in combination chemotherapy

  Definition of dose-limiting toxicity (DLT) * Hematologic DLT: delayed recovery of ANC/platelets \> 42 days * Grade 3 creatinine elevation, proteinuria, hyperbilirubinemia, bleeding * Grade 2 arterial thrombosis * Any grade 4 toxicities except hematologic toxicities

  42 days

Secondary Outcomes (3)

• Rate of tumor response (neuroblastoma)

  4 weeks

• Rate of tumor response (brain tumor)

  4 weeks

• Rate of tumor response (other solid tumors)

  4 weeks

Study Arms (1)

Pazopanib + conventional chemotherapy

EXPERIMENTAL

Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib

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

Interventions

Pazopanib DRUG

Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib

Pazopanib + conventional chemotherapy

Ifosfamide DRUG

Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib

Pazopanib + conventional chemotherapy

Carboplatin DRUG

Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib

Pazopanib + conventional chemotherapy

Etoposide DRUG

Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib

Pazopanib + conventional chemotherapy

Eligibility Criteria

• Age: 2 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)"

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Ministry of Health, Republic of Korea: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

pazopanib; Ifosfamide; Carboplatin; Etoposide

Intervention Hierarchy (Ancestors)

Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Ki Woong Sung, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ki Woong Sung, MD, PhD

CONTACT

82-2-3410-3529; kiwoong.sung@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 14, 2018
• Study Start: October 1, 2018
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2025
• Last Updated: September 19, 2018

Record last verified: 2018-09

Locations

KR (1)