Solid Tumor Treatment with MK-1775 and Irinotecan – Phase I/II

Study of MK-1775 (AZD1775) in Combination with Oral Irinotecan in Children, Adolescents, and Young Adults with Relapsed or Refractory Solid Tumors

Protocol Description

Through this Children’s Oncology Group (COG) study, researchers are evaluating the effectiveness of the drug MK-1775 (AZD1775) given in combination with irinotecan against recurrent tumors and tumors that will not respond to standard therapy. MK-1775 has shown potential in laboratory tests. This program evaluates the effects of the drug on tumors, as well as its side effects and how the body processes it. This study is an initiative of COG’s Pediatric Early Phase Clinical Trial Network of which UPMC Children’s Hospital of Pittsburgh is a part.

Study Level: Phase I/II

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling participants, ages 12 months to 21 years, who have recurrent or progressive a recurrent or progressive neuroblastoma, medulloblastoma/CNS PNET, or rhabdomyosarcoma.
Males and Females: Ages 12 months to 21 years

Requirements

Participants will take MK-1775 and irinotecan orally once a day for the first 5 days of a 21-day cycle. During the study, participants will have tests and procedures such as imaging and blood draws, as well as physical examinations at specific intervals. Participants may remain in the study for up to 18 cycles, unless they develop serious side effects or their tumors worsen.
Visits: The same number as with standard care for these conditions.
Duration: Up to 18 cycles of therapy (about a year)

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ADVL1312)
National Cancer Institute

Primary Investigator

Jean Tersak, MD

Contact Information

For more information about the study or enrollment, please contact:
Andrew Bukowinski MD, MS
412-692-5055