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Trial record 3 of 2867 for:    Pancreatic Cancer AND pancreas

Exceptional Responders With Pancreatic Cancer to Chemotherapy

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ClinicalTrials.gov Identifier: NCT02555735
Recruitment Status : Enrolling by invitation
First Posted : September 22, 2015
Last Update Posted : April 26, 2019
Sponsor:
Collaborators:
Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University
The Pancreatic Cancer Treatment Center of Los Angeles
Information provided by (Responsible Party):
Adera Labs, LLC

Brief Summary:
This is an observational study enrolling patients with metastatic pancreatic cancer to identify genomic differences between exceptional responder and non-responders to standard of care chemotherapy. Data analysis of the gene expression profile of the exceptional responders compared to non-responders will define genomic patterns that may help understand their response to chemotherapy.

Condition or disease Intervention/treatment
Pancreatic Neoplasms Drug: Standard of care chemotherapy

Detailed Description:
This is an observational study of patients with metastatic pancreatic cancer to identify genomic differences obtained from their circulating tumor cells between exceptional responders and non-responders to standard of care chemotherapy. This study requires a 10 mL heparinized peripheral blood sample from each study participant at the time of enrollment to isolate, enrich and profile circulating tumor cells. Data analysis of the gene expression profile will define genomic patterns using Nearest Template Prediction for a predetermined panel of therapeutic agents based on standard of care. Chemotherapy selection is physician-choice. Information regarding disease progression will be gathered. Data analysis will be performed in study participants in the setting of ongoing disease progression.

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Exceptional Responders With Pancreatic Cancer
Study Start Date : October 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Metastatic Pancreatic Cancer
Participants with metastatic pancreatic cancer treated with physician-choice standard of care chemotherapy.
Drug: Standard of care chemotherapy



Primary Outcome Measures :
  1. Identify exceptional responders with pancreatic cancer to standard of care chemotherapy [ Time Frame: Six years ]
    Identify responders and non-responders


Secondary Outcome Measures :
  1. Correlation of genomic profiles from circulating tumor cells with overall survival [ Time Frame: Six years ]
    Genomic profiles correlated with progression free and overall survival



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
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with metastatic pancreatic cancer
Criteria

Inclusion Criteria:

  • Histological or cytological confirmation of metastatic pancreatic adenocarcinoma.
  • Patient is treatment-naïve or currently receiving front-line chemotherapy with FOLFIRINOX or GEMCITABINE-ABRAXANE and has stable disease.
  • ECOG performance status 0-2.
  • Patients must have a hemoglobin of 7.5 g/dl or greater and be hemodynamically stable and/or physiologically compensated for their anemia

Exclusion Criteria:

  • HIV positive on antiretroviral therapy
  • Disease progression following front-line chemotherapy
  • Pregnant or lactating
  • Prior organ allograft
  • Any medical or psychiatric condition that may interfere with the ability to comply with protocol treatment

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): NCT02555735


Locations
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United States, California
The Pancreatic Cancer Treatment Center of Los Angeles
Los Angeles, California, United States, 90024
Sponsors and Collaborators
Adera Labs, LLC
Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University
The Pancreatic Cancer Treatment Center of Los Angeles
Investigators
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Study Director: Brian McCarthy, PhD Adera Labs

Publications:
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Responsible Party: Adera Labs, LLC
ClinicalTrials.gov Identifier: NCT02555735     History of Changes
Other Study ID Numbers: ADRL-003
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Keywords provided by Adera Labs, LLC:
pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases