Actively Recruiting
Investigation of Profile-related Evidence Determining Individualized Cancer Therapy for Patients With Aggressive Malignancies and Poor Prognoses
Led by Medical College of Wisconsin · Updated on 2025-05-15
400
Participants Needed
1
Research Sites
419 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, open-label navigational investigation designed to evaluate the feasibility of using molecular profile-based evidence to determine individualized cancer therapy for patients with aggressive malignancies. This is a non-randomized, histology-agnostic trial. Although there will be a case mix of histologies, the investigators now know that individual histologies are composed of a heterogeneous mix of molecular alterations. It is not clear whether one case mix is better or worse than another. Thus, the investigators are testing a strategy of molecular matching that may apply across different cancers.
CONDITIONS
Official Title
Investigation of Profile-related Evidence Determining Individualized Cancer Therapy for Patients With Aggressive Malignancies and Poor Prognoses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 4518 years
- Diagnosis of aggressive solid malignancy with at least one of these: 30% or higher two-year cancer-associated mortality, refusal of standard therapies, or cancer of unknown primary/rare tumor with no approved treatments
- No treatment option expected to provide significant clinical benefit in investigator's opinion
- Disease status includes unresectable, medically unfit for surgery with expected survival over three months, localized eligible for neoadjuvant treatment, metastatic, or no conventional therapy benefits survival over six months
- Treatment nafve for newly diagnosed malignancy (Groups 1 or 2) or previously treated with one or more systemic therapies (Group 3)
- Measurable disease with at least one lesion measurable by conventional or advanced imaging
- ECOG Performance Status 0-2
- New York Heart Association Functional Class I-II
- Adequate organ and marrow function with specified blood counts and liver/kidney function
- Off other anti-tumor agents for specified washout periods before treatment
- Able to swallow and retain oral medication if needed
- Provide evaluable tissue or blood for molecular profiling if not previously done
- Use effective contraception during and after study treatment as specified
- Ability to understand and sign informed consent
- Presentation at Molecular Tumor Board within two weeks prior to consent if applicable
You will not qualify if you...
- Disagreement between two oncologists on prognosis or tumor resectability
- Severe or uncontrolled medical disorders that may affect treatment response analysis
- Pregnant or breastfeeding, or childbearing potential without adequate pregnancy prevention
- Whole brain radiation or stereotactic radiotherapy to CNS metastases within 14 days before starting treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Medical College of Wisconsin Cancer Center Clinical Trials Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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