NCT01130623

A Phase I Study of Pazopanib as a Single Agent for Children With Refractory Solid Tumors

Withdrawn Phase 1 Last updated 2 July 2017

What this trial tests

Phase 1 trial testing Pazopanib (GW786034) in Sarcoma. Withdrawn.

Timeline

10 May 2010

Primary endpoint
18 November 2011

18 November 2011

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	10 May 2010
Primary completion	18 November 2011
Estimated completion	18 November 2011
Sites	1 location across United States

Drugs / interventions tested

• Pazopanib (GW786034) — full drug profile →

Conditions studied

• Sarcoma — all drugs for Sarcoma →
• Neuroblastoma — all drugs for Neuroblastoma →
• Wilms Tumor — all drugs for Wilms Tumor →
• Osteosarcoma — all drugs for Osteosarcoma →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 1 to 25, any sex, with Sarcoma or Neuroblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

\- Pazopanib, a drug that inhibits the growth of new blood vessels in tumors, was recently approved by the Food and Drug Administration to treat advanced kidney cancer in adults. Pazopanib has been used in only a small number of adults, and more research is needed on whether it is safe and effective to use in children. Researchers are interested in determining safe and effective treatment doses of pazopanib in children, and in other studies will examine which form of pazopanib treatment (tablet or liquid) is most effective and well tolerated.

Objectives:

* To determine a safe and effective dose of pazopanib to treat solid tumors in children.
* To study the effects of pazopanib on blood cells, blood flow, and human development.

Eligibility:

\- Children, adolescents, and young adults between 1 and 21 years of age who have been diagnosed with solid tumors that have not responded to treatment.

Design:

* Eligible participants will be screened with a physical examination, blood and tumor samples, and imaging studies.
* Participants will receive pazopanib tablets for 28-day cycles of treatment. Pazopanib should be taken on an empty stomach, at least 1hour before or 2 hours after a meal. Participants may receive pazopanib for up to 24 cycles unless the tumor does not respond or participants develop serious side effects.
* Blood samples will be taken on days 1, 15, 22, and 27 of the first cycle of pazopanib, with additional samples taken every 8 weeks during subsequent cycles.
* An optional part of the study will collect additional blood samples at regular intervals for 24 hours after the first dose of pazopanib and at regular intervals after another dose during the second or third week of the first treatment cycle.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Osteosarcoma: Cells-of-Origin, Cancer Stem Cells, and Targeted Therapies.
   Abarrategi A, Tornin J, Martinez-Cruzado L, Hamilton A, et al · · 2016 · cited 155× · PMID 27366153 · DOI 10.1155/2016/3631764
2. Targeting the Tumor Microenvironment in Neuroblastoma: Recent Advances and Future Directions.
   Joshi S. · · 2020 · cited 58× · PMID 32722460 · DOI 10.3390/cancers12082057