Spots Global Cancer Trial Database for PRE-I-SPY Phase I/Ib Oncology Platform Program
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Trial Identification
Brief Title: PRE-I-SPY Phase I/Ib Oncology Platform Program
Official Title: PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/Ib Platform Trial
Study ID: NCT05868226
Conditions
Study Description
Brief Summary: I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and/or other oncology-based trials in a timely manner.
Detailed Description: The PRE-I-SPY/I-SPY-P1 study is a platform trial with multiple ongoing drug regimen arms. In most cases, the treatment arm will have a dose-finding group (Part 1) and a dose-expansion group (Part 2). Eligibility criteria will vary according to the experimental regimen. Participant eligibility may vary according to the arm or the part within the study arm, including with respect to diagnosis. Arms could include participants diagnosed with certain solid tumors or specifically with breast cancer. Arms may restrict enrollment to a certain molecular pathway abnormality or histologic diagnosis. The trial allows for various study arm designs, with the goal to complete analysis of a study arm in 12 to 18 months.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois, United States
UChicago Medicine Comprehensive Cancer Center at Silver Cross Hospital, New Lenox, Illinois, United States
UChicago Medicine Orland Park, Orland Park, Illinois, United States
University of Minnesota Masonic Cancer Center, Minneapolis, Minnesota, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: Paula R Pohlmann, MD, MSc, PhD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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