ADVL1211 – A Phase 1 Study of XL184 (Cabozantinib) in Children and Adolescents with Recurrent or Refractory Solid Tumors, including CNS Tumors
Relapsed or refractory solid tumors, including CNS tumors and malignant melanoma. There is a separate stratum for patients with medullary thyroid cancer. Patient’s current disease state must be one for which there are no known curative treatment options or therapies proven to prolong survival with an acceptable quality of life.
XL184 (cabozantinib) is an oral small molecule inhibitor of multiple tyrosine kinases, which contribute to the pathogenesis of a number of solid tumors. XL184 will be administered orally daily, on an empty stomach. Tablets must be swallowed whole. Therapy may continue as long as the patient has at least stable disease and has not experienced significant toxicity warranting discontinuation of the drug.
- Patients must be between 2 and 18 years of age.
- Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy and have the appropriate wash-out period from most recent cancer directed therapy.
- Must have adequate organ function as evidenced by laboratory criteria.
- Patients must have a blood pressure that is less than the 95th% for age, height, and gender and not receiving any medications for the treatment of hypertension.
- Patients with a seizure disorder must have seizures that are well controlled on non-enzyme inducing anticonvulsants.
- Patients cannot have a history of congenital prolonged QTc syndrome or NYHA Class III or IV congestive heart failure
- No clinically significant cardiac arrhythmias, stroke, or myocardial infarction within 6 months prior to study enrollment
- Patients receiving corticosteroids must be on a stable or decreasing dose for at least 7 days prior to enrollment.
- Must not be receiving drugs that are potent CYP3A4 inducers or inhibitors, systemic treatment anticoagulation, enzyme-inducing anticonvulsants, QTc-prolonging agents, or anti-GVHD agents post-transplant.
- Must be able to swallow intact tablets.
- Must not have any active bleeding or clinically significant GI bleeding, GI perforation, intra-abdominal abscess, or fistula for 6 months prior to enrollment. Must not have had hemoptysis or other signs of pulmonary hemorrhage for 3 months prior to enrollment.
- Must not have acute intracranial or intratumor hemorrhage; any evidence of previous hemorrhage must be resolving.
- Must not have had or are planning to have any major surgical procedures, laparoscopic procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment and surgical or other wounds must be adequately healed prior to enrollment.
- Must not have any medical or surgical condition that would interfere with GI absorption.
- Must not have an uncontrolled infection.
- Must not have received a prior solid organ transplantation.
For the current status and more detailed eligibility criteria of these clinical studies & protocols, referring physicians and families may call the Developmental Therapeutics Program directly at (832) 824-4266 at any time. Kate Mazur, a pediatric nurse practitioner for the Developmental Therapeutics Program, will answer any questions or concerns you may have. You may need to leave a voice mail, and she will return your call as soon as possible. She may also be reached by email at firstname.lastname@example.org.