Trial Outcomes & Findings for RNA Precision Oncology in Advanced Pancreatic Cancer (NCT NCT04476537)

NCT ID: NCT04476537

Last Updated: 2025-04-03

Results Overview

The primary outcome of the study is whether a subject is assigned a therapy that they are able to begin on Part 2 of this study. Assignment of therapy is based on results from OncoTreat analysis and recommendations of the Precision Medicine Tumor Board (PMTB) which included assessment of availability and expected toxicity of identified agents.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

36 months

Results posted on

2025-04-03

Participant Flow

Sixteen participants enrolled (signed a consent form); however, only one participant started as all others were ineligible or withdrew consent prior to initiation.

Participant milestones

Participant milestones
Measure
Intervention Arm
Individuals who meet the eligibility criteria based on their provided tissue sample will be followed by the investigators to obtain medical information every 4 weeks. This follow-up will consist of a review of medical records, contact with the participant's treating physician, or personal contact between the participant and the investigators at Columbia University Irving Medical Center (CUIMC). During the study, their tumor tissue will be evaluated to identify medications that may help treat the cancer. The results of these tests will be reviewed by experts on a Precision Medicine Tumor Board (PMTB) and these experts may recommend a specific treatment to the participant or participant's physician.These participants will continue to be followed until death or withdrawal of consent from the study. OncoTreat: OncoTreat is a computational pipeline that begins with a tumor expression profile and ends with a list of several candidate regimens.
Overall Study
STARTED
1
Overall Study
COMPLETED
1
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RNA Precision Oncology in Advanced Pancreatic Cancer

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 36 months

Population: Data was not analyzed or disclosed in an effort to protect participant confidentiality (n=1).

The primary outcome of the study is whether a subject is assigned a therapy that they are able to begin on Part 2 of this study. Assignment of therapy is based on results from OncoTreat analysis and recommendations of the Precision Medicine Tumor Board (PMTB) which included assessment of availability and expected toxicity of identified agents.

Outcome measures

Outcome data not reported

Adverse Events

Intervention Arm

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gulam Manji, MD

Columbia University

Phone: 212-342-5162

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place