Spots Global Cancer Trial Database for Safety and Pharmacokinetic Study of IT-141 in Monotherapy in Patients With Advanced Cancer
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Trial Identification
Brief Title: Safety and Pharmacokinetic Study of IT-141 in Monotherapy in Patients With Advanced Cancer
Official Title: A Phase 1 With Expansion Cohort, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Intravenously Infused IT-141 in Subjects With Recurrent or Refractory Solid Tumors
Study ID: NCT03096340
Interventions
Study Description
Brief Summary: IT141 is a novel nanoparticle formulation of SN-38, the active metabolite of irinotecan, and is intended to deliver more drug to the tumor with reduced toxicity on normal tissues. The study is designed to determine the maximum tolerated dose (MTD) of IT-141, and to investigate pharmacokinetic (PK) parameters and possible pharmacodynamics (PD) relationships. Patients will also be monitored for any response to therapy.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mary Crowley Cancer Research Centers - Medical City, Dallas, Texas, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Contact Details
Name: Minal Barve, MD
Affiliation: Mary Crowley Cancer Research Centers - Medical City
Role: PRINCIPAL_INVESTIGATOR
Name: Kit Wong, MD
Affiliation: Seattle Cancer Care Alliance
Role: PRINCIPAL_INVESTIGATOR
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