• Return to search results
• Start new search

Investigator(s):
Brigitte Widemann, M.D. Principal Investigator Phone: 301-496-7387 widemanb@mail.nih.gov
Referral Contact(s):
Pediatric Oncology Phone: 301-496-4256 1-877-624-4878 (Toll free)

---

Key Eligibility Criteria:

• Children ≥ 2 and ≤ 18 years of age at the time of enrollment who can swallow intact tablets
• Diagnosis
• Part A: Patients with relapsed or refractory solid tumors including CNS tumors
• Part B: Patients with medullary thyroid carcinoma (MTC) with or without bone marrow involvement
• Performance level ≥ 50 percent (Lansky or Karnofsky)
• Must have adequate hematologic, hepatic, renal, and cardiac status and must meet safety laboratory testing level and have recovered from the acute toxic effects of all prior anti-cancer chemotherapy
• May not be receiving any contraindicated medications or treatments (e.g., corticosteroids, other investigational drugs, other anti-cancer therapies, anti-GVHD agents post-transplant, or potent CYP3A4 inducers or inhibitors)

---

Study Outline:

• This is a Phase I trial for children and adolescents in which XL184 will be administered orally at approximately the same time on an empty stomach, on a chronic dosing schedule for 28-day cycles; using a standard Phase I design, in Part A, patients will be enrolled at the starting dose of 30 mg/m² (dose level 2 is 40 mg/m², and dose level 3 is 50 mg/m²)
• Patients with medullary thyroid carcinoma (MTC) may be accrued to a separate stratum (Part B), if there are no available slots in Part A, where they will be enrolled at one dose level below the Part A dose level (or at the starting dose, if dose escalation has not yet occurred); patients with MTC will be allowed intra-patient dose escalation per protocol, and patients must complete the patient diary daily
• Toxicity will be closely monitored; the dose limiting toxicity (DLT) observation period is defined as the first cycle of therapy; doses may be held or reduced for toxicity; response will be assessed using RECIST every other cycle X 2, and then every third cycle; cycles may be repeated every 28 days in the absence of progressive disease or unacceptable toxicity
• PK samples will be collected during Cycle 1 (Day 1 and 21) and Cycle 3 (Day 1), and if applicable, at the time a patient experiences DLT; in addition, pharmacodynamic blood samples will be collected and archival tumor tissue slides will be analyzed, which may include evaluation of the signaling pathways related to cabozantinib targets
• To complete both Part A and Part B, a maximum of 69 patients may be enrolled; a maximum of 5 patients will be enrolled at NCI; enrolling up to 2 patients per month, this study is expected to last up to 32 months

---

Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 
Updated: 12/27/12