Pazopanib Hydrochloride in Treating Young Patients With Solid Tumors That Have Relapsed or Not Responded to Treatment
A Phase I Study of Pazopanib as a Single Agent for Children With Relapsed or Refractory Solid Tumors
5 other identifiers
interventional
55
1 country
14
Brief Summary
This phase I trial is studying the side effects and best dose of pazopanib hydrochloride in treating young patients with solid tumors that have relapsed or not responded to treatment. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 27, 2009
CompletedFirst Posted
Study publicly available on registry
June 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedSeptember 30, 2013
September 1, 2013
3.8 years
June 27, 2009
September 27, 2013
Conditions
Outcome Measures
Primary Outcomes (3)
Maximum-tolerated dose of pazopanib hydrochloride defined as the maximum dose at which fewer that one-third of patients experience DLT
Graded using the NCI CTCAE version 4.0.
28 days
Adverse events according to NCI CTCAE version 4.0
Up to 30 days after completion of study treatment
Pharmacokinetics of pazopanib hydrochloride
Summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).
Baseline, days 15, 22, and 27 of course 1 and day 1 of odd courses
Secondary Outcomes (1)
Overall response to pazopanib hydrochloride according to RECIST criteria
Up to 30 days after completion of study treatment
Study Arms (1)
Treatment (pazopanib hydrochloride)
EXPERIMENTALPatients receive oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Given orally
Correlative studies
Eligibility Criteria
You may qualify if:
- Diagnosis of 1 of the following:
- NOTE: Histologic confirmation not required for intrinsic brain stem cell tumor, optic pathway gliomas, pineal tumors and elevations of cerebrospinal fluid, and serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin.
- Histologically confirmed relapsed or refractory solid tumors at original diagnosis including CNS tumors\* (Part 1 and Part 2a)
- Neurologic deficits in patients with CNS tumors must have been relatively stable for ≥ 1 week
- Histologically confirmed soft tissue sarcoma, desmoplastic small round cell tumor, or extraosseus Ewing sarcoma at original diagnosis including the following (Part 2b):
- Tumor in the head, neck, or extremity or fixed within the abdomen or pelvis that it is not sensitive to motion artifact
- No isolated pulmonary metastases
- Disease with no known curative therapy or no therapy proven to prolong survival with acceptable quality of life
- Measurable or evaluable disease (Part 1 and Part 2a)
- Measurable tumor that is ≥ 2 cm in its longest diameter (Part 2b)
- Patients must be:
- \> 2 years of age and ≤ 21 years of age (Part 1 and Part 2a)
- \> 2 years of age and ≤ 25 years of age (Part 2b)
- Body surface area ≥ 0.48 m\^2 (Part 1 and Part 2b)
- For patients with CNS tumors or CNS metastasis, there must be no evidence of new CNS hemorrhage of more than punctate size and/or \> 3 foci of punctate hemorrhage on baseline MRI for primary CNS tumors ≥ 14 days prior to study entry
- +72 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Lurie Children's Hospital-Chicago
Chicago, Illinois, 60614, United States
Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Columbia University Medical Center
New York, New York, 10032, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Related Publications (1)
Glade Bender JL, Lee A, Reid JM, Baruchel S, Roberts T, Voss SD, Wu B, Ahern CH, Ingle AM, Harris P, Weigel BJ, Blaney SM. Phase I pharmacokinetic and pharmacodynamic study of pazopanib in children with soft tissue sarcoma and other refractory solid tumors: a children's oncology group phase I consortium report. J Clin Oncol. 2013 Aug 20;31(24):3034-43. doi: 10.1200/JCO.2012.47.0914. Epub 2013 Jul 15.
PMID: 23857966DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julia Glade-Bender
COG Phase I Consortium
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2009
First Posted
June 30, 2009
Study Start
June 1, 2009
Primary Completion
April 1, 2013
Last Updated
September 30, 2013
Record last verified: 2013-09