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Next Generation Sequencing-Based Stratification of Front Line Treatment of HighGrade Neuroendocrine Carcinoma (PRECISION-NEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04452292
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Aman Chauhan, University of Kentucky

Brief Summary:
PRECISION-NEC is a single-center, open-label, pilot feasibility study of molecularly defined subtypes of metastatic high-grade neuroendocrine carcinoma (HG-NEC). The hypothesis is that HG-NEC (excluding small cell carcinoma) can be segregated based on mutational analysis and that NGS-based assignment of therapy is feasible and will potentially improve the outcomes.

Condition or disease Intervention/treatment Phase
Large-Cell Neuroendocrine Carcinoma Other: Treatment Specific for Non-Small Cell Carcinoma/Adenocarcinoma Other: Treatment for Small Cell Lung Cancer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Feasibility Study of Next Generation Sequencing-Based Stratification of Front Line Treatment of HighGrade Neuroendocrine Carcinoma
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: No TP53/Rb1 Co-Mutation
HG-LCNEC tumor lacking the TP53/Rb1 co-mutation (non-small cell-like).
Other: Treatment Specific for Non-Small Cell Carcinoma/Adenocarcinoma
Treatment assigned to targetable mutation. Or, for tumors that are by and large without any targetable mutation follow NCCN guideline-directed best front-line treatment for specific non-small cell carcinoma/adenocarcinoma.

Experimental: TP53/Rb1 Co-Mutation Present
HG-LCNEC tumor with the TP53/Rb1 co-mutation.
Other: Treatment for Small Cell Lung Cancer
Treatment assigned to a targetable mutation or the current standard-of-care regimen for the treatment of small cell lung cancer.




Primary Outcome Measures :
  1. Sequencing Rate (Feasibility) [ Time Frame: 2 months ]
    Percentage of patients able to be sequenced within 2 months of the initial medical oncology visit.

  2. Molecular Cohort Assignment (Feasibility) [ Time Frame: 2 months ]
    Percentage of patients who were successfully assigned into a molecularly-definted cohort (TP53/RB1 co-mutations or not).


Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: 2 years ]
    Duration of time from the first cycle of anticancer therapy to time of progressive disease or death from any cause, whichever occurs first.

  2. Complete Response Rate [ Time Frame: 2 years ]
    Percentage of patients experiencing overall complete response (CR).

  3. Partial Response Rate [ Time Frame: 2 years ]
    Percentage of patients experiencing overall partial response (PR).

  4. Progressive Disease Rate [ Time Frame: 2 years ]
    Percentage of patients experiencing overall progressive disease (PD).

  5. Stable Disease Rate [ Time Frame: 2 years ]
    Percentage of patients experiencing overall stable disease (SD).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed high grade neuroendocrine carcinoma that is metastatic and/or not resectable
  • Adequate tissue available for genomic sequencing
  • ECOG status less than or equal to 2
  • Able to consent
  • Patient received up to two cycles of chemotherapy prior to enrollment
  • Adequate bone marrow function
  • Adequate hepatic function
  • Adequate renal function

Exclusion Criteria:

  • Small cell carcinoma
  • Psychiatric illness or social situations that limit compliance
  • Pregnant and nursing women
  • Patients who have completed more than two cycles of chemotherapy
  • Patients with resectable cancer or eligible for curative therapy
  • Patients with an actionalbe mutation for with guidelines recommend up-front therapy with targeted agents

Information from the National Library of Medicine

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): NCT04452292


Contacts
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Contact: Aman Chauhan, MD 859257-7715 amanchauhan@uky.edu

Locations
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United States, Kentucky
Markey Cancer Center, University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Aman Chauhan
Investigators
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Principal Investigator: Aman Chauhan, MD University of Kentucky
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Responsible Party: Aman Chauhan, Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT04452292    
Other Study ID Numbers: MCC-20-GI-112-PMC
KL2TR001996 ( U.S. NIH Grant/Contract )
UL1TR001998 ( U.S. NIH Grant/Contract )
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Aman Chauhan, University of Kentucky:
poorly differentiated neuroendocrine carcinoma
NGS
TP53/Rb1
comutation
molecular subtype
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Neuroendocrine
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue