A Phase I/Ib, Open-Label, Dose-Escalation and Expansion Study of Entrectinib (RXDX-101) in Children and Adolescents with Recurrent or Refractory Solid Tumors and Primary CNS Tumors
Patients must have relapsed or refractory solid tumors or CNS tumors. 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.
Entrectinib is a potent inhibitor of multiple tyrosine kinases, which are known to be important drivers of tumorigenesis in many cancers. In addition, Entrectinib crosses the blood brain barrier, enabling potential targeting of CNS lesions. Entrectinib will be administered orally once daily in repeated 4-week cycles on an outpatient basis. Patients with CNS tumors will be enrolled in a separate cohort at one dose level below the dose that has been established for patients with extracranial solid tumors.
- Patients must be between 2 and 21 years of age.
- Must be able to swallow intact capsules.
- Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy or surgery and have the appropriate wash-out period from most recent cancer directed therapy.
- Must have adequate organ function as evidenced by laboratory as well as EKG criteria.
- Patients must not have known congenital long QT syndrome.
- Must not have a known active infection.
- Must not have received Enyzme Inducing Antiepileptic Drugs within 14 days prior to enrollment.
- Must not have an active gastrointestinal disease (e.g. Crohn’s disease, ulcerative colitis, short gut syndrome) or other malabsorption syndrome that would impact drug absorption.
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.