Clinical trial · Observational
Genomic Profiling Assay in Phase I
A Study Exploring the Use of the Foundation Medicine Genomic Profiling Assay in a Phase I Solid Tumor Patient Population
NCT02437617CI-TRIAL-00052265completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The goal of this research study is to collect and test tumor tissue from patients with advanced cancers that may be enrolled in Phase 1 studies or other treatments. Researchers will study if the results from genetic testing can help researchers determine which therapy may prove more beneficial for a patient in the future.
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 |
|---|---|---|---|
| Advanced Cancers | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor Tissue | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Control Group #1
- description
- Participants who have had tumor molecular analysis performed with the similar clinical characteristics and genomic aberrations but who receive therapy not matched to their aberrations, or who have received results from Foundation Medicine that fail to demonstrate any molecular alteration.
- interventionNames
- Procedure: Tumor Tissue
- label
- Control Group #2
- description
- Participants from historical archives of MD Anderson, no older than two years, who received therapy not matched to their aberrations and are matched not only on the basis of the clinical characteristics, but also, as much as possible, on the basis of genomic aberrations.
- interventionNames
- Procedure: Tumor Tissue
- label
- Matched Targeted Therapy Group
- description
- Participants with tumor aberrations who received matched targeted therapy.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria 1. Patients with advanced cancer. 2. Consent for use of archival tissue from primary or metastatic cancer diagnosis. Note: Patients may currently be enrolled in other investigational protocol including treatment protocols. 3. Control Group #2 only: Control Group #2 will consist of 100 patients from MDACC/Phase I historical archives. Patients (cases no older than 2 years) will be selected based on clinical characteristics and genomic alterations similar to matched targeted therapy group. 4. Patients may have received prior 'matched' therapies; however, at the time of enrollment, patients may not currently be on a known 'matched' therapy, and may not have received a 'matched' therapy as the last treatment if not receiving treatment at the time of consent. 5. Patients who have a life expectancy of greater than 3 months. Exclusion Criteria: 1. Patients with advanced cancer who are NOT likely to meet the additional enrollment criteria in matched targeted therapy protocols or treatments. 2. Patients who do not have archival tissue available. 3. Patients are excluded if their last treatment before enrollment included a targeted agent matched to a genomic alteration in the patient's tumor.
References
Publications (1)
- DERIVEDWheler JJ, Janku F, Naing A, Li Y, Stephen B, Zinner R, Subbiah V, Fu S, Karp D, Falchook GS, Tsimberidou AM, Piha-Paul S, Anderson R, Ke D, Miller V, Yelensky R, Lee JJ, Hong DS, Kurzrock R. Cancer Therapy Directed by Comprehensive Genomic Profiling: A Single Center Study. Cancer Res. 2016 Jul 1;76(13):3690-701. doi: 10.1158/0008-5472.CAN-15-3043. Epub 2016 May 18. PMID 27197177