Pancreatic Ductal AdenocarcinomaNCT05630989
A Registry to Capture Patient Outcomes With KRAS G12R Altered Advanced Pancreatic Ductal Adenocarcinoma Treated With MEK Inhibitor-based Combination Therapy
An observational study of Pancreatic Ductal Adenocarcinoma, run by Mandana Kamgar, MD at 1 site in United States.
Trial summary
This is an observational precision oncology study designed to collect and analyze data that allows us to characterize the safety and efficacy of several different mitogen-activated protein kinase kinase inhibitor (MEKi) -based treatment strategies and the feasibility of administering MEKi combination therapies to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- combination therapy with no MEKi, combination therapy with MEKi-HCQ and combination therapy with MEKi-EGFRi
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2023to 1 Aug 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Subjects have advanced PDAC with KRAS G12R mutation.
Who may be able to join
- Age ≥18 years.
- Diagnosis of advanced pancreatic ductal adenocarcinoma as determined by the treating physician or tumor board.
- Tumor must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician.
- Ability to understand a written informed consent document and the willingness to sign it.
Who cannot join
- Age <18 years.
- Primary cancer diagnosis other than advanced pancreatic ductal adenocarcinoma
- Tumor does not have a KRAS G12R mutation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Mandana Kamgar, MD, 414-805-4600, mkamgar@mcw.edu
About this study
This is an observational precision oncology study designed to collect and analyze data that allows us to characterize the safety and efficacy of several different mitogen-activated protein kinase kinase inhibitor (MEKi) -based treatment strategies and the feasibility of administering MEKi combination therapies to patients with KRAS G12R mutated advanced pancreatic ductal adenocarcinoma (PDAC).
Read the detailed description
Patient medical records, obtained both retrospectively and prospectively, will be examined for results of molecular profiling obtained through standard of care testing to help understand how well KRAS G12R pancreatic patients respond to MEKi-based combination matched therapy. Patient outcome parameters including but not limited to tumor response, patient survival, and toxicity will be analyzed. Moreover, metrics will be collected to ascertain whether a future clinical trial involving a MEKi-based combination therapy is feasible to carry out.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- combination therapy with no MEKi, combination therapy with MEKi-HCQ, combination therapy with MEKi-EGFRi, combination therapy with MEKi.
- Keywords
- Pancreatic Ductal Adenocarcinoma, KRAS G12R mutation, Precision medicine, Retrospective Chart Review, Prospective Chart Review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination therapy with no MEKiOther
Also called mitogen-activated extracellular signal-regulated kinase inhibitor
This cohort will receive combination therapy with no MEKi.
combination therapy with MEKi-HCQDrug
Also called mitogen-activated extracellular signal-regulated kinase inhibitor with hydroxychloroquine
This cohort will receive combination therapy with MEKi-HCQ.
combination therapy with MEKi-EGFRiDrug
Also called mitogen-activated extracellular signal-regulated kinase inhibitor with epidermal growth factor receptor inhibitor
This cohort will receive combination therapy with MEKi-EGFRi.
combination therapy with MEKi.Drug
Also called mitogen-activated extracellular signal-regulated kinase inhibitor
This cohort will receive combination therapy with MEKi.
| Study group | Role | What they receive |
|---|---|---|
| Therapy with no MEKi | Subjects have advanced PDAC with KRAS G12R mutation. Subjects' tumors must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician. Subjects will receive therapy with no MEKi. Receives: Other: combination therapy with no MEKi | |
| Therapy with MEKi- Hydroxychloroquine (HCQ) | Subjects have advanced PDAC with KRAS G12R mutation. Subjects' tumors must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician. Subjects will receive therapy with MEKi and HCQ. Receives: Drug: combination therapy with MEKi-HCQ | |
| Therapy with MEKi- Epidermal growth factor receptor inhibitor (EGFRi) | Subjects have advanced PDAC with KRAS G12R mutation. Subjects' tumors must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician. Subjects will receive combination therapy with MEKi and EGFRi. Receives: Drug: combination therapy with MEKi-EGFRi | |
| Therapy with MEKi-Other | Subjects have advanced PDAC with KRAS G12R mutation. Subjects' tumors must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician. Subjects will receive combination therapy with MEKi and a specified drug combination. Receives: Drug: combination therapy with MEKi. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects with no progression.
This is defined as the time from the start of treatment until six months on treatment, or disease progression, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death, whichever occurs first.
Measured: 6 months
Secondary outcomes (4)
The number of subjects who have a complete response.
A complete response will be determined using RECIST v1.1.
Measured: 2 years
The number of subjects who have a partial response.
A partial response will be determined using RECIST v1.1.
Measured: 2 years
The number of grade 3 adverse events at least possibly related to a drug.
Adverse events and serious adverse events will be classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Measured: 2 years
The number of grade 4 adverse events at least possibly related to a drug.
Adverse events and serious adverse events will be classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start7 Feb 2023
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Mandana Kamgar, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mandana Kamgar, MD, Medical College of Wisconsin
- Investigators
- Mandana Kamgar, MD, MPH, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630989
- Sponsor's protocol ID
- PRO00045718
- Status last verified
- Apr 2026
- First submitted
- 20 Nov 2022
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry to Capture Patient Outcomes With KRAS G12R Altered Advanced Pancreatic Ductal Adenocarcinoma Treated With MEK Inhibitor-based Combination Therapy
- ClinicalTrials.gov ID
- NCT05630989
- Acronym / sponsor ID
- PRO00045718
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- Pancreatic Ductal Adenocarcinoma, KRAS G12R mutation, Precision medicine, Retrospective Chart Review, Prospective Chart Review
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mandana Kamgar, MDUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational precision oncology study designed to collect and analyze data that allows us to characterize the safety and efficacy of several different mitogen-activated protein kinase kinase inhibitor (MEKi) -based treatment strategies and the feasibility of administering MEKi combination therapies to patients with KRAS G12R mutated advanced pancreatic ductal adenocarcinoma (PDAC).
Detailed description
Patient medical records, obtained both retrospectively and prospectively, will be examined for results of molecular profiling obtained through standard of care testing to help understand how well KRAS G12R pancreatic patients respond to MEKi-based combination matched therapy. Patient outcome parameters including but not limited to tumor response, patient survival, and toxicity will be analyzed. Moreover, metrics will be collected to ascertain whether a future clinical trial involving a MEKi-based combination therapy is feasible to carry out.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Therapy with no MEKi | – | Other: combination therapy with no MEKiSubjects have advanced PDAC with KRAS G12R mutation. Subjects' tumors must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician. Subjects will receive therapy with no MEKi. |
| Therapy with MEKi- Hydroxychloroquine (HCQ) | – | Drug: combination therapy with MEKi-HCQSubjects have advanced PDAC with KRAS G12R mutation. Subjects' tumors must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician. Subjects will receive therapy with MEKi and HCQ. |
| Therapy with MEKi- Epidermal growth factor receptor inhibitor (EGFRi) | – | Drug: combination therapy with MEKi-EGFRiSubjects have advanced PDAC with KRAS G12R mutation. Subjects' tumors must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician. Subjects will receive combination therapy with MEKi and EGFRi. |
| Therapy with MEKi-Other | – | Drug: combination therapy with MEKi.Subjects have advanced PDAC with KRAS G12R mutation. Subjects' tumors must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician. Subjects will receive combination therapy with MEKi and a specified drug combination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects have advanced PDAC with KRAS G12R mutation.
Key inclusion criteria (4 listed)
- Age ≥18 years.
- Diagnosis of advanced pancreatic ductal adenocarcinoma as determined by the treating physician or tumor board.
- Tumor must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician.
- Ability to understand a written informed consent document and the willingness to sign it.
Key exclusion criteria (3 listed)
- Age <18 years.
- Primary cancer diagnosis other than advanced pancreatic ductal adenocarcinoma
- Tumor does not have a KRAS G12R mutation.
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 |
|---|---|---|
| combination therapy with no MEKiAlso: mitogen-activated extracellular signal-regulated kinase inhibitorThis cohort will receive combination therapy with no MEKi. | Other | Therapy with no MEKi |
| combination therapy with MEKi-HCQAlso: mitogen-activated extracellular signal-regulated kinase inhibitor with hydroxychloroquineThis cohort will receive combination therapy with MEKi-HCQ. | Drug | Therapy with MEKi- Hydroxychloroquine (HCQ) |
| combination therapy with MEKi-EGFRiAlso: mitogen-activated extracellular signal-regulated kinase inhibitor with epidermal growth factor receptor inhibitorThis cohort will receive combination therapy with MEKi-EGFRi. | Drug | Therapy with MEKi- Epidermal growth factor receptor inhibitor (EGFRi) |
| combination therapy with MEKi.Also: mitogen-activated extracellular signal-regulated kinase inhibitorThis cohort will receive combination therapy with MEKi. | Drug | Therapy with MEKi-Other |
Primary outcome
The number of subjects with no progression.
Time frame: 6 months
This is defined as the time from the start of treatment until six months on treatment, or disease progression, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death, whichever occurs first.
4 secondary outcomes
The number of subjects who have a complete response.
Time frame: 2 years
The number of subjects who have a partial response.
Time frame: 2 years
The number of grade 3 adverse events at least possibly related to a drug.
Time frame: 2 years
The number of grade 4 adverse events at least possibly related to a drug.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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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.
Mandana Kamgar, MD, MPH principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Ductal Adenocarcinoma, run by Mandana Kamgar, MD 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 5 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mandana Kamgar, MD, MPH (414-805-4600, mkamgar@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of subjects with no progression. (time frame: 6 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 5 May 2026.