Personalized Cancer Therapy for Patients With Metastatic Medullary Thyroid or Metastatic Colon Cancer
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|ClinicalTrials.gov Identifier: NCT02363647|
Recruitment Status : Enrolling by invitation
First Posted : February 16, 2015
Last Update Posted : July 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Medullary Thyroid Cancer Colon Cancer||Other: Tumor Genomic Analysis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Personalized Cancer Therapy for Patients With Metastatic Medullary Thyroid or Metastatic Colon Cancer|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Experimental: Tumor Genomic Analysis
Personalized Therapy Plan Patients with Metastatic Medullary or Colon Cancer being treated with the Personalized Treatment Plan developed during the different tumor genomic analysis study.
Other: Tumor Genomic Analysis
Tumor mutations identified by deep DNA and RNA sequencing of individual tumors are screened for tumor drivers, which are then incorporated into the "personal" Drosophila model and tested against a library of FDA approved drugs. Fly mortality is used as a surrogate for toxicity and increased survival to adulthood; improvements in tumor mutation-linked eye and/or wing abnormalities serve to quantify efficacy. This allows rapid and parallel screening of FDA approved drugs and subsequent drug combinations. The most efficacious and least toxic combinations are tested in xenograft models and a multidisciplinary tumor board of experts select the best therapeutic option. The objective is to demonstrate that the personalized drosophila model approach is superior to the current standard. Patient will be offered an unique "personalized" single drug or combination of drugs, all FDA approved, based on the Drosophila drug screening process.
- Overall response rate (ORR) [ Time Frame: up to 3 years ]ORR as the sum of partial responses (PRs) and complete responses (CRs)
- Progression-free Survival (PFS) [ Time Frame: up to 3 years ]The length of time during and after the treatment of disease that a patient lives with the disease but it does not get worse.
- Overall survival (OS) [ Time Frame: up to 3 years ]The length of time from either the date of diagnosis or the start of treatment for disease, that patients diagnosed with the disease are still alive.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02363647
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Krzysztof Misiukiewicz, MD||Icahn School of Medicine at Mount Sinai|