A Phase 1 Study of LY2606368 a CHK1/2 Inhibitor in Pediatric Patients With Recurrent or Refractory Solid Tumors Including CNS Tumors
James Croop, MD, PhD
Primary Investigator
Brief description of study
This phase I trial studies the side effects and best dose of prexasertib in treating pediatric patients with solid tumors that have come back after a period of time during which the tumor could not be detected or does not respond to treatment.
Detailed description of study
The purpose of this study is to estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose of prexasertib (LY2606368) administered as an intravenous (IV) infusion over 60 minutes, every 14 days of a 28-day cycle to children with recurrent or refractory solid tumors; to define and describe the toxicities of LY2606368 administered on this schedule; and to characterize the pharmacokinetics of LY2606368 in children with recurrent or refractory cancer.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Solid Tumor,Cancer,Childhood Solid Neoplasm,Recurrent Central Nervous System Neoplasm,Refractory Central Nervous System Neoplasm
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Age: 1 years - 21 years
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Gender: All
Inclusion Criteria
Patients with recurrent or refractory solid tumors, including central nervous system (CNS) tumors, are eligible
Patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or in patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)
Patients must have either measurable or evaluable disease
Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
Exclusion Criteria
Pregnant or breast-feeding women will not be entered on this study
Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method both during and for 3 months after participation in this study; abstinence is an acceptable method of contraception
Corticosteroids: Patients receiving corticosteroids must have been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
Investigational drugs: Patients who are currently receiving another investigational drug are not eligible
Anti-cancer agents: Patients who are currently receiving other anti-cancer agents are not eligible
Anti-GVHD agents post-transplant: Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial
Strong CYP1A2 inhibitors: Patients must not have received strong CYP1A2 inhibitors (ciprofloxacin, fluvoxamine, zafirlukast) for at least 7 days prior to enrollment and must not receive them for the duration of the study
Patients who have an uncontrolled infection are not eligible
Patients who have received a prior solid organ transplantation are not eligible
Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to LY2606368 or to its formulation are not eligible
Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
