ADVL0815: Phase I Study Pazopanib Single Agent for Solid Tumor

Why are we doing this research?

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.

Who can participate?

Diagnosis of 1 of the Following:
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 extraosseous 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
  • Slides or tissue blocks from either initial diagnosis or relapse must be available for central review
  • 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.
  • 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 m2 (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


  • Neurology


  • Female
  • Male

What will happen in the study?

This is a multicenter study.

Patients receive oral pazopanib hydrochloride (Part 1 and Part 2a) 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. Patients accrued after the maximum-tolerated dose (MTD) of pazopanib hydrochloride has been determined receive pazopanib hydrochloride as either an oral suspension or in its standard oral form. (Part 2b)

Some patients undergo dynamic contrast-enhanced MRI at baseline and periodically during study.

Blood samples are collected at baseline and periodically during study for pharmacokinetic studies.


Cincinnati Children’s Hospital Medical Center
Division of Hematology/Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: 513-636-2799