Clinical trial NCT04476537: RNA Precision Oncology in Advanced Pancreatic Cancer
Official title: A Phase Ib High-throughput Pancreas Precision Oncology Study Investigating the Feasibility, Efficacy, and Pharmacodynamics of Cell Regulatory-network Analysis Based Therapy Selection in Advanced Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Pancreatic ductal adenocarcinoma (PDA)
Precision medicine
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The overall objective of this project is to determinate the feasibility of administering personalized therapy to subjects with advanced pancreatic cancer utilizing the novel OncoTreat platform. The primary objective of this study is to assess the feasibility of implementing the OncoTreat framework in patients with newly diagnosed, untreated metastatic pancreatic adenocarcinoma.

Detailed description: Pancreatic ductal adenocarcinoma (PDA) is a major health problem in the United States and throughout the world. Pancreatic ductal adenocarcinoma (PDA) has the worst prognosis of any major malignancy in the United States and, unlike other common cancers, annual deaths from PDA are rising. During 2017, it is estimated that 53,670 people were diagnosed with PDA and approximately 43,090 people died from PDA in the U.S. Despite recent advances, cytotoxic chemotherapy for PDA has been disappointing with response rates of 20-30% for the most active regimens and little activity for targeted therapies. Even among the small subset of patients who are suitable for surgical resection at the time of diagnosis, complete resection is followed by recurrence in \>90% of patients without further systemic therapy, with a median time to recurrence of 6.9 months. Thus all PDA patients require systemic chemotherapy and more effective regimens are urgently needed.

Previous versions of this record contained reference to an observational arm in error. The observational arm has been removed from the record for consistency with the study protocol.

Eligibility criteria: Inclusion Criteria:

* Be willing and able to provide written informed consent for the trial.
* Age ≥18 years of age on day of signing informed consent.
* Have histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma or be willing to undergo a biopsy with confirmed pathology prior to starting therapy.
* Have untreated disease that is unresectable due to being metastatic or locally advanced without potential of surgery as assessed by the treating physician.
* Subjects who have documented disease recurrence greater than 6 months after completing neoadjuvant or adjuvant chemotherapy for limited disease will be eligible for the study.
* Have a predicted life expectancy of greater than 6 months.
* Subjects must have a plan to obtain a new core biopsy of a primary and/or metastatic lesion planned as part of routine care for which consent is obtained separately or (b) consent to be biopsied to satisfy the tissue requirements of this protocol.

Exclusion Criteria:

Has previously received neoadjvuant or adjuvant chemotherapy for pancreatic cancer unless greater than 6 months has passed since completion of adjuvant or neoadjuvant chemotherapy and initiation of therapy for recurrent or metastatic disease.

Primary outcomes:
measure: Number of Participants Assigned Therapy With OncoTreat
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Gulam Manji, MD
role: PRINCIPAL_INVESTIGATOR
References: