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Individualized Cancer Therapy for Aggressive Cancers (MCW I-PREDICT Trial)
Phase 1 & 2
Recruiting
Led By Razelle Kurzrock, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 months
Awards & highlights
MCW I-PREDICT Trial Summary
This trial tests a new approach to individualize cancer treatments based on molecular changes in a patient's cancer. It could lead to better outcomes for patients.
Who is the study for?
Adults with aggressive solid tumors, including rare cancers or those without beneficial standard therapies. Eligible participants must have measurable disease, adequate organ function, and not be pregnant or breastfeeding. They should agree to use contraception and have no severe medical conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing personalized cancer treatments based on molecular profiling of individual tumors against standard care agents. It's a non-randomized study aiming to see if matching therapy to specific molecular changes in different cancers can improve outcomes.See study design
What are the potential side effects?
Potential side effects depend on the targeted agent used but may include typical reactions like fatigue, nausea, allergic responses to medication components, liver function changes, blood count variations and increased risk of infections due to immune system impact.
MCW I-PREDICT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Matched treatment
Secondary outcome measures
Actionable alterations
MTB recommended treatment
MCW I-PREDICT Trial Design
6Treatment groups
Experimental Treatment
Group I: Group 3: Targeted agentExperimental Treatment1 Intervention
Subjects will be grouped into one of three study groups (Groups 1, 2, or 3) based on their disease status and history of prior cancer therapy. Group 3 will comprise subjects with metastatic or unresectable disease who have received at least one prior systemic therapy, whether matched or unmatched.
Group II: Group 3: Standard of care agentExperimental Treatment1 Intervention
Subjects will be grouped into one of three study groups (Groups 1, 2, or 3) based on their disease status and history of prior cancer therapy. Group 3 will comprise subjects with metastatic or unresectable disease who have received at least one prior systemic therapy, whether matched or unmatched.
Group III: Group 2: Targeted agentExperimental Treatment1 Intervention
Subjects will be grouped into one of three study groups (Groups 1, 2, or 3) based on their disease status and history of prior cancer therapy. Group 2 will comprise treatment naïve subjects with metastatic disease.
Group IV: Group 2: Standard of care agentExperimental Treatment1 Intervention
Subjects will be grouped into one of three study groups (Groups 1, 2, or 3) based on their disease status and history of prior cancer therapy. Group 2 will comprise treatment naïve subjects with metastatic disease.
Group V: Group 1: Targeted agentExperimental Treatment1 Intervention
Subjects will be grouped into one of three study groups (Groups 1, 2, or 3) based on their disease status and history of prior cancer therapy. Group 1 subjects will comprise treatment naïve subjects with localized disease and (i) are eligible for neoadjuvant treatment, (ii) have unresectable disease, or (iii) are medically unfit for surgical resection.
Group VI: Group 1: Standard of care agentExperimental Treatment1 Intervention
Subjects will be grouped into one of three study groups (Groups 1, 2, or 3) based on their disease status and history of prior cancer therapy. Group 1 subjects will comprise treatment naïve subjects with localized disease and (i) are eligible for neoadjuvant treatment, (ii) have unresectable disease, or (iii) are medically unfit for surgical resection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Targeted agent
2013
N/A
~200
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
610 Previous Clinical Trials
1,162,313 Total Patients Enrolled
Razelle Kurzrock, MDPrincipal InvestigatorMedical College of Wisconsin
9 Previous Clinical Trials
110,290 Total Patients Enrolled
Ben George, MDPrincipal InvestigatorMedical College of Wisconsin
2 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe illnesses that could affect the study's results.I am 18 years old or older.I have not had brain radiation within the last 14 days.I have a serious cancer with limited treatment options or a rare type with no approved treatments.My condition cannot be treated with surgery, or I am not fit for surgery but expected to live more than three months, or my disease is in a stage where it might benefit from treatment before surgery, or it has spread to other parts of the body, or there is no standard treatment that would extend my life by more than six months.
Research Study Groups:
This trial has the following groups:- Group 1: Group 3: Standard of care agent
- Group 2: Group 1: Targeted agent
- Group 3: Group 1: Standard of care agent
- Group 4: Group 2: Targeted agent
- Group 5: Group 2: Standard of care agent
- Group 6: Group 3: Targeted agent
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still availabilities to participate in this experiment?
"Per the clinicaltrials.gov data, there is no longer active recruitment for this particular trial which was first posted January 1st 2023 and last updated on December 23rd 2022. Nevertheless, 2734 other studies are currently seeking participants."
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