Pancreatic CancerHIPPOCRATESNCT04476537
RNA Precision Oncology in Advanced Pancreatic Cancer
A study testing OncoTreat in people with Pancreatic Cancer, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- OncoTreat
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2020to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
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
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.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- OncoTreat
- Keywords
- Pancreatic ductal adenocarcinoma (PDA), Precision medicine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OncoTreatDevice
OncoTreat is a computational pipeline that begins with a tumor expression profile and ends with a list of several candidate regimens.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 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. Receives: Device: OncoTreat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Assigned Therapy With OncoTreat
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start7 Dec 2020
- Primary completion15 Jul 2022
- Study completion31 Mar 2023
Why it stopped: Lack of feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulam Manji, Columbia University
- Investigators
- Gulam Manji, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476537
- Sponsor's protocol ID
- AAAR6703
- Acronym
- HIPPOCRATES
- Status last verified
- Mar 2025
- First submitted
- 15 Jul 2020
- Last updated
- 3 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04476537
- Acronym / sponsor ID
- HIPPOCRATES / AAAR6703
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic ductal adenocarcinoma (PDA), Precision medicine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of feasibility
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Posted 3 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: OncoTreatIndividuals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OncoTreatOncoTreat is a computational pipeline that begins with a tumor expression profile and ends with a list of several candidate regimens. | Device | Intervention Arm |
Primary outcome
Number of Participants Assigned Therapy With OncoTreat
Time frame: 36 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Pancreatic Cancer
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gulam Manji, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OncoTreat in people with Pancreatic Cancer, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Assigned Therapy With OncoTreat (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.