Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05868226
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2022-04-22
Brief Title:
PRE-I-SPY Phase IIb Oncology Platform Program
Sponsor:
QuantumLeap Healthcare Collaborative
Organization:
QuantumLeap Healthcare Collaborative
Study Overview
Official Title:
PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis A Phase IIb Platform Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRE-I-SPY-PI
Brief Summary:
I-SPY Phase IIb 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 andor other oncology-based trials in a timely manner
Detailed Description:
The PRE-I-SPYI-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None