Clinical trial · Interventional
Personalized Cancer Therapy for Patients With Metastatic Medullary Thyroid or Metastatic Colon Cancer
NCT02363647CI-TRIAL-00060608terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No Current Funding
Summary
Brief summary (as posted)
The Personalized Discovery Process is the only program offering patients treatment recommendations based on an empirically constructed Drosophila "fly" model of their disease. Special committee selects one of the one of the few 2-3 FDA approved drug combinations or single agents that improved survival in the fly cancer model.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Medullary Thyroid Cancer | Thyroid Gland Medullary Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor Genomic Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tumor Genomic Analysis
- description
- 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.
- interventionNames
- Other: Tumor Genomic Analysis
Primary outcomes (1)
- measure
- Overall response rate (ORR)
- timeFrame
- up to 3 years
- description
- ORR as the sum of partial responses (PRs) and complete responses (CRs)
Secondary outcomes (2)
- measure
- Progression-free Survival (PFS)
- timeFrame
- up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients already enrolled to the separate Tumor Genomic Analysis and Molecular Testing for Personalized Cancer Therapy study, for which a personalized therapeutic plan has been successfully created under that protocol and selected by the multidisciplinary tumor board of experts for use in this therapeutic clinical trial * Histologically confirmed MTC by a Mount Sinai pathologist * Recurrent/metastatic or incurable MTC * Age \> 18 years old * Life expectancy must exceed 1 year from enrollment in the study * Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 * The subject has documented worsening of disease (progressive disease) at screening compared with a previous CT scan or MRI image done within 14 months of screening Documentation of progression may be made by CT, MRI, or PET assessment * Adequate organ and bone marrow function defined by routine testing * The subject has no other diagnosis of cancer (unless non-melanoma skin cancer, an early form of cervical cancer, or another cancer diagnosed ≥ 2 years previously) and currently has no evidence of active other malignancy (unless non-melanoma skin cancer or an early form of cervical cancer) * Signed and dated informed consent form indicating that the patient has been informed of all pertinent aspects of the trial prior to enrolment Exclusion Criteria: * Patients who are currently receiving and responding to a different course of anti-neoplastic therapy, within the limits of acceptable toxicity per standard clinical practice, may not be enrolled to this study * Current symptomatic brain metastases. If previously present, the metastases must have been treated at least two months before participation in this study. CT or MRI scan of the brain is mandatory to assess the presence or not of brain metastases * History of other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or basal cell, or squamous cell carcinoma of the skin * History of significant cardiac disease defined as: * Symptomatic CHF (NYHA classes III-IV) * High-risk uncontrolled arrhythmias; i.e. atrial tachycardia with a heart rate \> 100/min at rest, significant ventricular arrhythmia or higher-grade AV-block (second degree AV-block Type 2 \[Mobitz 2\] or third degree AV-block) * Prolongation of QT interval \> 480 msecs * History of myocardial infarction within last 12 months * Clinically significant valvular heart disease * Angina pectoris requiring anti-angina treatment * Current uncontrolled hypertension (persistent systolic \> 180 mmHg and/or diastolic \> 100 mmHg). Initiation or adjustment of antihypertensive medication is permitted prior to study entry * Evidence of active bleeding or bleeding diathesis * Cerebrovascular accident at any time in the past, transient ischemic attack, deep venous thrombosis or pulmonary embolism in the past 6 months * Current severe, uncontrolled systemic disease * Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Failure to use contraception in patients with preserved reproductive capacity
References
Publications (49)
- BACKGROUNDHundahl SA, Fleming ID, Fremgen AM, Menck HR. A National Cancer Data Base report on 53,856 cases of thyroid carcinoma treated in the U.S., 1985-1995 [see commetns]. Cancer. 1998 Dec 15;83(12):2638-48. doi: 10.1002/(sici)1097-0142(19981215)83:123.0.co;2-1. PMID 9874472
- BACKGROUNDSaad MF, Ordonez NG, Rashid RK, Guido JJ, Hill CS Jr, Hickey RC, Samaan NA. Medullary carcinoma of the thyroid. A study of the clinical features and prognostic factors in 161 patients. Medicine (Baltimore). 1984 Nov;63(6):319-42. PMID 6503683
- BACKGROUNDZedenius J, Larsson C, Bergholm U, Bovee J, Svensson A, Hallengren B, Grimelius L, Backdahl M, Weber G, Wallin G. Mutations of codon 918 in the RET proto-oncogene correlate to poor prognosis in sporadic medullary thyroid carcinomas. J Clin Endocrinol Metab. 1995 Oct;80(10):3088-90. doi: 10.1210/jcem.80.10.7559902. PMID 7559902
- BACKGROUNDElisei R, Cosci B, Romei C, Bottici V, Renzini G, Molinaro E, Agate L, Vivaldi A, Faviana P, Basolo F, Miccoli P, Berti P, Pacini F, Pinchera A. Prognostic significance of somatic RET oncogene mutations in sporadic medullary thyroid cancer: a 10-year follow-up study. J Clin Endocrinol Metab. 2008 Mar;93(3):682-7. doi: 10.1210/jc.2007-1714. Epub 2007 Dec 11. PMID 18073307
- BACKGROUNDRomei C, Elisei R, Pinchera A, Ceccherini I, Molinaro E, Mancusi F, Martino E, Romeo G, Pacini F. Somatic mutations of the ret protooncogene in sporadic medullary thyroid carcinoma are not restricted to exon 16 and are associated with tumor recurrence. J Clin Endocrinol Metab. 1996 Apr;81(4):1619-22. doi: 10.1210/jcem.81.4.8636377. PMID 8636377
- BACKGROUNDEng C, Clayton D, Schuffenecker I, Lenoir G, Cote G, Gagel RF, van Amstel HK, Lips CJ, Nishisho I, Takai SI, Marsh DJ, Robinson BG, Frank-Raue K, Raue F, Xue F, Noll WW, Romei C, Pacini F, Fink M, Niederle B, Zedenius J, Nordenskjold M, Komminoth P, Hendy GN, Mulligan LM, et al. The relationship between specific RET proto-oncogene mutations and disease phenotype in multiple endocrine neoplasia type 2. International RET mutation consortium analysis. JAMA. 1996 Nov 20;276(19):1575-9.