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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

Tracking Information
First Submitted Date September 18, 2015
First Posted Date September 22, 2015
Last Update Posted Date April 26, 2019
Study Start Date October 2015
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 25, 2019)
Identify exceptional responders with pancreatic cancer to standard of care chemotherapy [ Time Frame: Six years ]
Identify responders and non-responders
Original Primary Outcome Measures
 (submitted: September 18, 2015)
Identify exceptional responders with pancreatic cancer to standard of care chemotherapy [ Time Frame: Two years ]
Tow years enrollment with one year follow-up
Change History Complete list of historical versions of study NCT02555735 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 25, 2019)
Correlation of genomic profiles from circulating tumor cells with overall survival [ Time Frame: Six years ]
Genomic profiles correlated with progression free and overall survival
Original Secondary Outcome Measures
 (submitted: September 18, 2015)
Correlation of genomic profiles from circulating tumor cells with overall survival [ Time Frame: two years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Exceptional Responders With Pancreatic Cancer to Chemotherapy
Official Title Evaluation of Exceptional Responders With Pancreatic Cancer
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients diagnosed with metastatic pancreatic cancer
Condition Pancreatic Neoplasms
Intervention Drug: Standard of care chemotherapy
Study Groups/Cohorts Metastatic Pancreatic Cancer
Participants with metastatic pancreatic cancer treated with physician-choice standard of care chemotherapy.
Intervention: Drug: Standard of care chemotherapy
Publications * Yu KH, Ricigliano M, McCarthy B, Chou JF, Capanu M, Cooper B, Bartlett A, Covington C, Lowery MA, O'Reilly EM. Circulating Tumor and Invasive Cell Gene Expression Profile Predicts Treatment Response and Survival in Pancreatic Adenocarcinoma. Cancers (Basel). 2018 Nov 24;10(12). pii: E467. doi: 10.3390/cancers10120467.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: April 25, 2019)
90
Original Estimated Enrollment
 (submitted: September 18, 2015)
30
Estimated Study Completion Date September 2021
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02555735
Other Study ID Numbers ADRL-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Adera Labs, LLC
Study Sponsor Adera Labs, LLC
Collaborators
  • Memorial Sloan Kettering Cancer Center
  • Weill Medical College of Cornell University
  • The Pancreatic Cancer Treatment Center of Los Angeles
Investigators
Study Director: Brian McCarthy, PhD Adera Labs
PRS Account Adera Labs, LLC
Verification Date April 2019