Pancreatic AdenocarcinomaPhase 1/2PANGEANCT06483555
Basal-like PDAC Treated With Gemcitabine, Erlotinib, and Nab-paclitaxel
A Phase 1/2 study testing Gemcitabine, Nab paclitaxel and Erlotinib in people with Pancreatic Adenocarcinoma and Metastatic Pancreatic Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This Phase I/II clinical trial is being conducted at multiple centers to find out whether adding a low dose of EGFR blocking drugs to the standard chemotherapy combination of gemcitabine and nab paclitaxel (GnP) is safe, tolerable, and helpful for people with advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma, Metastatic Pancreatic Cancer, Basal Cell Neoplasm
- What is being tested?
- Gemcitabine, Nab paclitaxel and Erlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2025to Aug 2027
- Phase
- Phase 1/2
- 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
Who may be able to join
- Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information. Subjects is willing and able to comply with study procedures based on the judgment of the investigator.
- Age ≥ 18 years at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 Histological or cytological evidence/confirmation of unresectable, borderline resectable, or metastatic (basal-like and classical) pancreatic adenocarcinoma.
- The subject must consent to a mandatory pre-study biopsy if archival tissue is not available or sufficient.
- Subjects may have received prior standard-of-care (SOC) neoadjuvant therapy and may have received up to two cycles of first-line FOLFIRINOX or NALIRIFOX.
- A subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to study treatment have been off of corticosteroids for ≥ 2 weeks and are asymptomatic.
Who cannot join
- Disease is not measurable according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1
- Not having histological or cytological evidence/confirmation of metastatic pancreatic adenocarcinoma.
- Treatment with any investigational drug or prior cancer treatment within 28 days prior to study treatment
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
University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Catherine A Griffin, 984-974-8771, catherine_griffin@med.unc.edu
Ashwin Somasundaram, MD
About this study
Official title: Subjects With Advanced Basal-like Pancreatic Adenocarcinoma Treated With Gemcitabine, Erlotinib and Nab-paclitaxel (PANGEA) Versus Subjects With Classical Pancreatic Adenocarcinoma Treated With Triplet Standard of Care Therapy.
This Phase I/II clinical trial is being conducted at multiple centers to find out whether adding a low dose of EGFR blocking drugs to the standard chemotherapy combination of gemcitabine and nab paclitaxel (GnP) is safe, tolerable, and helpful for people with advanced pancreatic cancer. All participants are first tested with a tool called PurIST, which classifies tumors as either "basal-like" or "classical." People with basal-like tumors will receive GnP plus erlotinib during Phase I so researchers can determine the safest and most effective dose. Once that dose is identified, the study moves to Phase II, where people with basal-like tumors will be randomly assigned to receive either GnP alone or GnP with erlotinib. Phase II may also test new drug combinations if new treatments become approved during the study period. Overall, the trial plans to include up to about 52 basal-like patients in Phase I, roughly 82 basal-like patients in Phase II, and at least 52 classical patients, with the possibility of enrolling more if needed. People whose tumors are classified as classical will continue with standard treatments recommended by their doctors or other clinical trials. Across the entire study, researchers will carefully track long-term outcomes such as overall survival, how long patients live before the cancer progresses, and how well their tumors respond to treatment.
- Being tested
- Gemcitabine, Nab paclitaxel, Erlotinib, NALIRIFOX, Folfirinox
- Keywords
- safety, tolerability, efficacy, EGFR inhibitors, gemcitabine, nab-paclitaxel
- Medical subject headings
- Pancreatic Neoplasms, Neoplasms, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemcitabine hydrochloride, FF 10832, LY188011, C9H11F2N3O4 - HCl
1000 mg/m2, intravenously on day 1 and day 15, for subjects with basal-like cell type pancreatic carcinoma.
Nab paclitaxelDrug
Also called Abraxane
125 mg/m2 intravenously on day 1 and day 15 for subjects with basal-like cell type pancreatic carcinoma.
ErlotinibDrug
Also called Tarceva
50 mg per oral daily. for subjects with basal-like cell type pancreatic carcinoma.
NALIRIFOXDrug
Also called A combination of liposomal irinotecan,5 fluorouracil /leucovorin and oxaliplatin.
Subjects with classical pancreatic adenocarcinoma will receive. NALIRIFOX is liposomal irinotecan with 5-fluorouracil/leucovorin and oxaliplatin. Dosing and plan will be decided by the treating physician.
FolfirinoxDrug
Also called It is a combination of leucovorin calcium (folinic acid), fluorouracil, irinotecan hydrochloride, and oxaliplatin
Subjects with classical pancreatic adenocarcinoma will receive. Dosing and plan will be decided by the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| PurIST Basal | Experimental | Subjects will be screened using the PurIST classifier and "basal-like" tumors will be assigned combination therapy with GnP and erlotinib. Receives: Drug: Gemcitabine; Drug: Nab paclitaxel; Drug: Erlotinib |
| PurIST Classical | Active comparator | Subjects will be screened using the PurIST classifier and with classical tumors will be treated per standard of care on triplet therapy. Receives: Drug: NALIRIFOX; Drug: Folfirinox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events per Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Adverse Events (AEs) will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, in Phase I subjects with basal-like settings. The number of participants with adverse events (AE) will be reported.
.
Measured: First day of study treatment through the 28 days after last treatment
Dose-limiting toxicity (DLT)
DLTs are defined using adverse events as at least possibly related to erlotinib administration in Phase I subjects. If an apparent DLT is clearly due to an underlying disease and is unrelated to the product infusion, then the investigator will specify that the event is not a DLT. Toxicities related to treatment and assessed Adverse Events per Common Terminology Criteria for Adverse Events (NCI-CTCAE) will be used for assessment.
The safety evaluation period for dose-limiting toxicity (DLT) assessment and determination of optimal best dose (OBD) will encompass toxicities related to treatment with low-dose erlotinib when administered with bi-weekly gemcitabine/nab-paclitaxel starting on the day of treatment initiation through the end of treatment.
Measured: Up to 28 days
Overall survival- classical metastatic pancreatic adenocarcinoma
Overall survival of subjects with classical metastatic pancreatic adenocarcinoma is defined as the length of time from the start of treatment until death.
Measured: 2 years
Progression-free survival
Progression-free survival in subjects on low-dose erlotinib when administered with bi-weekly gemcitabine/nab-paclitaxel with basal-like metastatic pancreatic adenocarcinoma is defined as the length of time between the start of treatment until progression or death.
Measured: 2 years
Secondary outcomes (6)
The number of Adverse Events (AEs) in subjects with basal like pancreatic carcinoma
The number of Adverse Events (AEs) in subjects with basal-like pancreatic carcinoma treated with low-dose erlotinib when administered with bi-weekly gemcitabine/nab-paclitaxel as defined by CTCAE v5.
Measured: First day of study treatment through the 28 days after last treatment
Overall survival in subjects with basal-like metastatic pancreatic adenocarcinoma
Overall survival in subjects with basal-like metastatic pancreatic adenocarcinoma on low-dose erlotinib when administered with bi-weekly gemcitabine/nab-paclitaxel is defined as the length of time from the start of treatment until death (basal-like arm only).
Measured: 2 years
The objective response in subjects with classical pancreatic adenocarcinoma
The objective response in subjects with classical pancreatic adenocarcinoma treated with standard-of-care triplet chemotherapy (FOLFIRINOX or NALIRIFOX) as defined as complete response (CR) + partial response (PR) as determined by RECIST 1.1 criteria.
Measured: Up to 12 weeks
The number of Adverse Events (AEs) in subjects with classical pancreatic adenocarcinoma
The number of Adverse Events (AEs) in subjects with classical pancreas carcinoma treated with standard-of-care triplet therapy as defined by CTCAE v5.0.
Measured: First day of study treatment through the 28 days after last treatment
Progression-free survival (PFS) in subjects with classical pancreatic adenocarcinoma
Progression-free survival (PFS) after standard-of-care triplet chemotherapy (FOLFIRINOX or NALIRIFOX) in patients with classical metastatic pancreatic adenocarcinoma is defined as the length of time between the start of standard-of-care triplet therapy until progression or death.
Measured: 2 years
The objective response rate- basal-like pancreatic carcinoma
The objective response rate in Stage 2 subjects with basal-like histology, treated with low-dose erlotinib at the OBD when administered with bi-weekly gemcitabine/nab-paclitaxel as defined as complete response (CR) + partial response (PR) as determined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1 criteria. RECIST indicates if the subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start6 Feb 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- a two-stage U-BOIN design
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashwin Somasundaram, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483555
- Sponsor's protocol ID
- LCCC2220-DCT
- Acronym
- PANGEA
- Status last verified
- Apr 2026
- First submitted
- 24 Jun 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subjects With Advanced Basal-like Pancreatic Adenocarcinoma Treated With Gemcitabine, Erlotinib and Nab-paclitaxel (PANGEA) Versus Subjects With Classical Pancreatic Adenocarcinoma Treated With Triplet Standard of Care Therapy.
- ClinicalTrials.gov ID
- NCT06483555
- Acronym / sponsor ID
- PANGEA / LCCC2220-DCT
- Keywords
- safety, tolerability, efficacy, EGFR inhibitors, gemcitabine, nab-paclitaxel
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 3 Jul 2024 (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 Phase I/II clinical trial is being conducted at multiple centers to find out whether adding a low dose of EGFR blocking drugs to the standard chemotherapy combination of gemcitabine and nab paclitaxel (GnP) is safe, tolerable, and helpful for people with advanced pancreatic cancer. All participants are first tested with a tool called PurIST, which classifies tumors as either "basal-like" or "classical." People with basal-like tumors will receive GnP plus erlotinib during Phase I so researchers can determine the safest and most effective dose. Once that dose is identified, the study moves to Phase II, where people with basal-like tumors will be randomly assigned to receive either GnP alone or GnP with erlotinib. Phase II may also test new drug combinations if new treatments become approved during the study period. Overall, the trial plans to include up to about 52 basal-like patients in Phase I, roughly 82 basal-like patients in Phase II, and at least 52 classical patients, with the possibility of enrolling more if needed. People whose tumors are classified as classical will continue with standard treatments recommended by their doctors or other clinical trials. Across the entire study, researchers will carefully track long-term outcomes such as overall survival, how long patients live before the cancer progresses, and how well their tumors respond to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a two-stage U-BOIN design
| Arm | Type | Receives |
|---|---|---|
| PurIST Basal | Experimental | Drug: Gemcitabine, Drug: Nab paclitaxel, Drug: ErlotinibSubjects will be screened using the PurIST classifier and "basal-like" tumors will be assigned combination therapy with GnP and erlotinib. |
| PurIST Classical | Active comparator | Drug: NALIRIFOX, Drug: FolfirinoxSubjects will be screened using the PurIST classifier and with classical tumors will be treated per standard of care on triplet therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information. Subjects is willing and able to comply with study procedures based on the judgment of the investigator.
- Age ≥ 18 years at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 Histological or cytological evidence/confirmation of unresectable, borderline resectable, or metastatic (basal-like and classical) pancreatic adenocarcinoma.
- The subject must consent to a mandatory pre-study biopsy if archival tissue is not available or sufficient.
- Subjects may have received prior standard-of-care (SOC) neoadjuvant therapy and may have received up to two cycles of first-line FOLFIRINOX or NALIRIFOX.
Key exclusion criteria (3 listed)
- Disease is not measurable according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1
- Not having histological or cytological evidence/confirmation of metastatic pancreatic adenocarcinoma.
- Treatment with any investigational drug or prior cancer treatment within 28 days prior to study treatment
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 |
|---|---|---|
| GemcitabineAlso: Gemcitabine hydrochloride, FF 10832, LY188011, C9H11F2N3O4 - HCl1000 mg/m2, intravenously on day 1 and day 15, for subjects with basal-like cell type pancreatic carcinoma. | Drug | PurIST Basal |
| Nab paclitaxelAlso: Abraxane125 mg/m2 intravenously on day 1 and day 15 for subjects with basal-like cell type pancreatic carcinoma. | Drug | PurIST Basal |
| ErlotinibAlso: Tarceva50 mg per oral daily. for subjects with basal-like cell type pancreatic carcinoma. | Drug | PurIST Basal |
| NALIRIFOXAlso: A combination of liposomal irinotecan,5 fluorouracil /leucovorin and oxaliplatin.Subjects with classical pancreatic adenocarcinoma will receive. NALIRIFOX is liposomal irinotecan with 5-fluorouracil/leucovorin and oxaliplatin. Dosing and plan will be decided by the treating physician. | Drug | PurIST Classical |
| FolfirinoxAlso: It is a combination of leucovorin calcium (folinic acid), fluorouracil, irinotecan hydrochloride, and oxaliplatinSubjects with classical pancreatic adenocarcinoma will receive. Dosing and plan will be decided by the treating physician. | Drug | PurIST Classical |
Primary outcome
Adverse Events per Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Time frame: First day of study treatment through the 28 days after last treatment
Adverse Events (AEs) will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, in Phase I subjects with basal-like settings. The number of participants with adverse events (AE) will be reported. .
Dose-limiting toxicity (DLT)
Time frame: Up to 28 days
DLTs are defined using adverse events as at least possibly related to erlotinib administration in Phase I subjects. If an apparent DLT is clearly due to an underlying disease and is unrelated to the product infusion, then the investigator will specify that the event is not a DLT. Toxicities related to treatment and assessed Adverse Events per Common Terminology Criteria for Adverse Events (NCI-CTCAE) will be used for assessment. The safety evaluation period for dose-limiting toxicity (DLT) assessment and determination of optimal best dose (OBD) will encompass toxicities related to treatment with low-dose erlotinib when administered with bi-weekly gemcitabine/nab-paclitaxel starting on the day of treatment initiation through the end of treatment.
Overall survival- classical metastatic pancreatic adenocarcinoma
Time frame: 2 years
Overall survival of subjects with classical metastatic pancreatic adenocarcinoma is defined as the length of time from the start of treatment until death.
Progression-free survival
Time frame: 2 years
Progression-free survival in subjects on low-dose erlotinib when administered with bi-weekly gemcitabine/nab-paclitaxel with basal-like metastatic pancreatic adenocarcinoma is defined as the length of time between the start of treatment until progression or death.
6 secondary outcomes
The number of Adverse Events (AEs) in subjects with basal like pancreatic carcinoma
Time frame: First day of study treatment through the 28 days after last treatment
Overall survival in subjects with basal-like metastatic pancreatic adenocarcinoma
Time frame: 2 years
The objective response in subjects with classical pancreatic adenocarcinoma
Time frame: Up to 12 weeks
The number of Adverse Events (AEs) in subjects with classical pancreatic adenocarcinoma
Time frame: First day of study treatment through the 28 days after last treatment
Progression-free survival (PFS) in subjects with classical pancreatic adenocarcinoma
Time frame: 2 years
The objective response rate- basal-like pancreatic carcinoma
Time frame: Up to 12 weeks
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 23 Apr 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- 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.
Ashwin Somasundaram, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gemcitabine, Nab paclitaxel and Erlotinib in people with Pancreatic Adenocarcinoma and Metastatic Pancreatic Cancer, run by UNC Lineberger Comprehensive Cancer Center 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 6 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 23 Apr 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Catherine A Griffin (1 984-974-8771, catherine_griffin@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events per Common Terminology Criteria for Adverse Events (NCI-CTCAE) (time frame: First day of study treatment through the 28 days after last treatment). The study lists 4 primary outcomes in all. 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 23 Apr 2026.