Clinical trial · Interventional
Molecular Profiling Protocol (SCRI-CA-001)
A Pilot Study Utilizing Molecular Profiling of Patients' Tumors to Find Potential Targets and Select Treatments for Their Refractory Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, multicenter pilot study in patients with advanced solid tumors. The primary objective of this study is to compare progression-free survival using a treatment regimen selected by molecular profiling with progression-free survival for the most recent regimen the patient has progressed on. To be eligible, patients must have received at least two lines of prior chemotherapeutic, hormonal or biological regimens for advanced disease, have measurable or evaluable, refractory disease and have clear documentation of the time between treatment start and documented progression on the last treatment prior to study entry. Eligible patients must undergo or have available a tumor biopsy for molecular profiling within 2 months of IHC/FISH and/or DNA microarray analysis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Treatment based on Molecular Profiling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To compare progression-free survival using a treatment regimen selected by molecular profiling with progression-free survival for the most recent regimen the patient has progressed on.
- timeFrame
- Every 8 weeks disease assessments are performed
Secondary outcomes (2)
- measure
- To determine the frequency with which molecular profiling of a patient's tumor by IHC/FISH and/or microarray analysis yields a target against which there is a commercially available, approved therapeutic regimen.
- timeFrame
- Time of Profiling- Baseline
- measure
- To determine the response rate (according to RECIST or disease-specific response criteria) and the percent of patients with non-progression at 4 months in patients with solid tumors whose therapy is selected by molecular profiling.
- timeFrame
- 4 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic cancer which has progressed on 2 prior chemotherapeutic, hormonal or biological regimens for advanced disease. * Be defined as refractory to the last line of therapy * Have documentation of the best clinical response to the treatment regimen immediately prior to entering this study Exclusion Criteria: * Patients with symptomatic CNS metastasis * Any previous history of another malignancy within 5 years of study entry * Uncontrolled intercurrent illness * Known HIV, HBV, HCV infection * Pregnant or breast-feeding
References
Publications (0)
Data not yet available