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Spots Global Cancer Trial Database for Adavosertib and Irinotecan Hydrochloride in Treating Younger Patients With Relapsed or Refractory Solid Tumors

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Study Description

Brief Summary: This phase I/II trial studies the side effects and best dose of adavosertib and irinotecan hydrochloride in treating younger patients with solid tumors that have come back (relapsed) or that have not responded to standard therapy (refractory). Adavosertib and irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Description: PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose of adavosertib (AZD1755 \[MK-1775\]) administered on days 1 through 5 every 21 days, in combination with oral irinotecan (irinotecan hydrochloride), to children with recurrent or refractory solid tumors. II. To define and describe the toxicities of AZD1755 (MK-1775) in combination with oral irinotecan administered on this schedule. III. To characterize the pharmacokinetics of AZD1755 (MK-1775) in children with refractory cancer. SECONDARY OBJECTIVES: I. To preliminarily define the antitumor activity of AZD1755 (MK-1775) and irinotecan within the confines of a Phase 1 study. II. To obtain initial phase 2 efficacy data on the anti-tumor activity of AZD1755 (MK-1775) in combination with irinotecan administered to children with relapsed or refractory neuroblastoma, in children with relapsed or refractory medulloblastoma/CNS PNET (central nervous system primitive neuroectodermal tumor) and in children with relapsed or refractory rhabdomyosarcoma. III. To investigate checkpoint over-ride by AZD1755 (MK-1775) via the mechanism-based pharmacodynamic (PD) biomarker of decreased cyclin-dependent kinase 1 (CDK1) phosphorylation in correlative and exploratory studies. IV. To evaluate potential predictive biomarkers of AZD1755 (MK-1775) sensitivity, including v-myc avian myelocytomatosis viral oncogene homolog (MYC), v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN), phosphorylated-WEE1 G2 checkpoint kinase (p-Wee1), enhancer of zeste homolog 2 (Drosophila) (EZH2) and gamma-H2A histone family, member gamma-(H2AX) in tumor tissues in correlative and exploratory studies. OUTLINE: This is a phase I, dose-escalation followed by a phase II study. Patients receive irinotecan hydrochloride orally (PO) and adavosertib PO on days 1-5. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.

Keywords

Eligibility

Minimum Age: 1 Year

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Children's Hospital of Alabama, Birmingham, Alabama, United States

Children's Hospital Los Angeles, Los Angeles, California, United States

Children's Hospital of Orange County, Orange, California, United States

UCSF Medical Center-Parnassus, San Francisco, California, United States

UCSF Medical Center-Mission Bay, San Francisco, California, United States

Children's Hospital Colorado, Aurora, Colorado, United States

Children's National Medical Center, Washington, District of Columbia, United States

Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States

Lurie Children's Hospital-Chicago, Chicago, Illinois, United States

Riley Hospital for Children, Indianapolis, Indiana, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

C S Mott Children's Hospital, Ann Arbor, Michigan, United States

University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States

Washington University School of Medicine, Saint Louis, Missouri, United States

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

Oregon Health and Science University, Portland, Oregon, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States

Saint Jude Children's Research Hospital, Memphis, Tennessee, United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States

Seattle Children's Hospital, Seattle, Washington, United States

Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States

Hospital for Sick Children, Toronto, Ontario, Canada

Contact Details

Name: Kristina A Cole

Affiliation: COG Phase I Consortium

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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