Exceptional Responders With Pancreatic Cancer to Chemotherapy

• Sponsor: Adera Labs, LLC (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT02555735
• Collaborator: Memorial Sloan Kettering Cancer Center (Other), Weill Medical College of Cornell University (Other), The Pancreatic Cancer Treatment Center of Los Angeles (Other)
• Enrollment: 90
• Location: 1
• Duration (Months): 95
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

This is an observational study enrolling patients with pancreatic cancer to identify genomic expression differences between exceptional responders 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	Phase
Pancreatic Neoplasms	Drug: Standard of care chemotherapy

Detailed Description

This is an observational study of patients with pancreatic cancer to identify genomic expression 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 Design

• Study Type: Observational
• Anticipated Enrollment: 90 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of Exceptional Responders With Pancreatic Cancer
• Study Start Date: Oct 1, 2015
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Identify exceptional responders with pancreatic cancer to standard of care chemotherapy [Six years]

   Identify responders and non-responders

Secondary Outcome Measures

1. Correlation of genomic profiles from circulating cells with overall survival [Six years]

   Genomic expression profiles correlated with progression free and overall survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histological or cytological confirmation of pancreatic adenocarcinoma.

• Patient is treatment-naïve or currently receiving chemotherapy.

• 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

• Pregnant or lactating

• Prior organ allograft

• Any medical or psychiatric condition that may interfere with the ability to comply with protocol treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

• Study Director: Brian McCarthy, PhD, Adera Labs

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Adera Labs, LLC
• ClinicalTrials.gov Identifier: NCT02555735
• Other Study ID Numbers: ADRL-003
• First Posted: Sep 22, 2015
• Last Update Posted: Nov 20, 2020
• Last Verified: Nov 1, 2020

• Keywords provided by Adera Labs, LLC: pancreatic cancer
• Additional relevant MeSH terms: Pancreatic Neoplasms

Study Results

No Results Posted as of Nov 20, 2020