Pancreatic CancerPhase 1NCT07549958
PhIbRandomGemcitabine(G)w/or w/Out Pitavastatin(P)MainTx UnresecPancreaticAdenocarcinoma(uPDAC)
A Phase 1 study testing Pitavastatin in people with Pancreatic Cancer and Pancreatic Cancer Metastatic, run by University of California, Irvine at 1 site in United States.
Trial summary
This is a phase 1, open-label clinical trial determining the recommended Phase 2 dose of Gemcitabine with Nab-paclitazel with or without Pitavastatin in subjects with unresectable pancreatic adenocarcinoma (uPDAC). These are subjects who are already receiving Gemcitabine for treatment of their disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Cancer Metastatic
- What is being tested?
- Pitavastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2026to 31 Mar 2028
- Phase
- Phase 1
- 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
- Age ≥ 18 years old
- Provision of a signed and dated ICF by the participant
- Has a diagnosis of histologically or cytologically confirmed metastatic, recurrent, or locally advanced PDAC
- Receiving a gemcitabine-based treatment regimen for a minimum of 2 and a maximum of 4 cycles without radiographic progression (ie SD or better).
- Measurable disease per RECIST 1.1
- Adequate organ (hematologic, hepatic, renal) function defined below:
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- Hemoglobin ≥ 9.0 g/dL (transfusion is allowed)
- Platelets ≥ 100,000/mcL (transfusion is allowed)
- ANC ≥ 1500/mcL
- AST/ALT ≤ 3 x ULN (≤ 5 x ULN is allowable in cases of liver metastasis or Gilbert's Syndrome)
- Serum bilirubin ≤ 1.5 x ULN
- Serum albumin ≥ 3.0 g/dL
- Serum creatinine ≤ 1.5 x ULN OR creatinine clearance > 60 mL/min
- ECOG PS 0-2
- 2 lines or less of prior treatment. Prior curative intent treatment (surgery and, if given in the adjuvant setting, systemic therapy and/or radiation) is permitted, regardless of time to recurrence, and does not constitute a line of therapy. This includes participants with residual disease after surgery, who received systemic therapy, chemoembolization, or radiotherapy.
Who cannot join
- Uncontrolled significant clinical illness
- Clinically significant autoimmune disease
- Major surgery within 4 weeks of the first dose of registration
- Known prior malignancy active within the previous 3 years, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
- Concomitant use of statin therapy (to be discontinued 2 weeks prior to the start of C1D1).
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HbsAg) are eligible.
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- Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
- Patients with a known history of HIV.
- Known active metastases in the central nervous system (unless stable by brain imaging studies for at least 1 month after last treatment)
- Patients with QT interval corrected by Fridericia's formula (QTcF) > 470 msec for both men and women on screening ECG are excluded.
- A woman of childbearing potential who has a positive pregnancy test prior to initiating study treatment.
- Breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Screening visit through 5 months after the last dose of study treatment.
- Medicines known to inhibit or induce either CYP2C8, CYP2C9, or CYP3A4
- History of prior organ or stem cell transplant.
- Has an active infection requiring systemic therapy. Systemic treatment used prophylactically is allowable.
- Patients who are unable to swallow or retain oral medication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
United States1 site, 1 recruiting
- Recruiting
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, 92868
Jennifer Valerin, MD, PhD, 877-827-8839, ucstudy@uci.edu
About this study
Official title: Phase Ib Randomized Study of Gemcitabine (G) With Nab-paclitaxel With or Without Pitavastatin (P) in the Maintenance Treatment of Unresectable Pancreatic Adenocarcinoma (uPDAC)
This is a phase 1, open-label clinical trial determining the recommended Phase 2 dose of Gemcitabine with Nab-paclitazel with or without Pitavastatin in subjects with unresectable pancreatic adenocarcinoma (uPDAC). These are subjects who are already receiving Gemcitabine for treatment of their disease.
- Conditions
- Pancreatic Cancer, Pancreatic Cancer Metastatic
- Being tested
- Pitavastatin
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PitavastatinDrug
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Pitavastatin, 1mg, Dose Level -1 | Experimental | Pitavastatin will be dosed starting on cycle 1 day 1, once orally daily on days 1-28 every 4 weeks. Receives: Drug: Pitavastatin |
| Pitavastatin, 2 mg, Dose Level 0 | Experimental | Pitavastatin will be dosed starting on cycle 1 day 1, once orally daily on days 1-28 every 4 weeks. Receives: Drug: Pitavastatin |
| Pitavastatin, 4 mg, Dose Level +1 | Experimental | Pitavastatin will be dosed starting on cycle 1 day 1, once orally daily on days 1-28 every 4 weeks. Receives: Drug: Pitavastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase II Dose
Determine the recommended phase II dose (RP2D) of Pitavastatin in combination with Gemcitabine and nab-paclitaxel in treatment of uPDAC and determine any adverse events.
Measured: 2 years
Secondary outcomes (4)
Number of Patients with Adverse Events
Number of Patients who received at least one dose of Gemcitabine and Nab-paclitaxel with Pitavastatin with any reported Adverse Events (AEs) using the CTCAE version 5.0 for reporting of nonhematologic AEs and modified criteria for hematologic AEs.
Measured: 2 years
Number of Patients who Discontinued Treatment Due to Reported Adverse Events
Number of Patients who received at least one dose of Gemcitabine and Nab-paclitaxel with Pitavastatin requiring discontinuation of therapy due to reported AEs using the CTCAE version 5.0 for reporting of nonhematologic AEs and modified criteria for hematologic AEs.
Measured: 2 years
Objective Response Rate (ORR) by RECIST v1.1
Sum of Complete Response (CR) and Partial Response (PR) by RECIST v 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. ORR = CR + PR for each dose cohort.
Measured: 2 years
Progression-Free Survival
Determine the progression-free survival (PFS) for each cohort. PFS is measured from the date of randomization to the first date of disease progression.
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 posted24 Apr 2026
- Study start24 Mar 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose Escalation
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Brooke Valerin, University of California, Irvine
- Investigators
- Jennifer Valerin, MD, PhD, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549958
- Sponsor's protocol ID
- STUDY00000701
- Other IDs
- UCI 24-105
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Randomized Study of Gemcitabine (G) With Nab-paclitaxel With or Without Pitavastatin (P) in the Maintenance Treatment of Unresectable Pancreatic Adenocarcinoma (uPDAC)
- ClinicalTrials.gov ID
- NCT07549958
- Acronym / sponsor ID
- STUDY00000701
- Conditions
- Pancreatic Cancer, Pancreatic Cancer Metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 24 Apr 2026 (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 a phase 1, open-label clinical trial determining the recommended Phase 2 dose of Gemcitabine with Nab-paclitazel with or without Pitavastatin in subjects with unresectable pancreatic adenocarcinoma (uPDAC). These are subjects who are already receiving Gemcitabine for treatment of their disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Dose Escalation
| Arm | Type | Receives |
|---|---|---|
| Pitavastatin, 1mg, Dose Level -1 | Experimental | Drug: PitavastatinPitavastatin will be dosed starting on cycle 1 day 1, once orally daily on days 1-28 every 4 weeks. |
| Pitavastatin, 2 mg, Dose Level 0 | Experimental | Drug: PitavastatinPitavastatin will be dosed starting on cycle 1 day 1, once orally daily on days 1-28 every 4 weeks. |
| Pitavastatin, 4 mg, Dose Level +1 | Experimental | Drug: PitavastatinPitavastatin will be dosed starting on cycle 1 day 1, once orally daily on days 1-28 every 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18 years old
- Provision of a signed and dated ICF by the participant
- Has a diagnosis of histologically or cytologically confirmed metastatic, recurrent, or locally advanced PDAC
- Receiving a gemcitabine-based treatment regimen for a minimum of 2 and a maximum of 4 cycles without radiographic progression (ie SD or better).
- Measurable disease per RECIST 1.1
Key exclusion criteria (16 listed)
- Uncontrolled significant clinical illness
- Clinically significant autoimmune disease
- Major surgery within 4 weeks of the first dose of registration
- Known prior malignancy active within the previous 3 years, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
- Concomitant use of statin therapy (to be discontinued 2 weeks prior to the start of C1D1).
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 |
|---|---|---|
| PitavastatinGiven PO | Drug | Pitavastatin, 1mg, Dose Level -1, Pitavastatin, 2 mg, Dose Level 0, Pitavastatin, 4 mg, Dose Level +1 |
Primary outcome
Recommended Phase II Dose
Time frame: 2 years
Determine the recommended phase II dose (RP2D) of Pitavastatin in combination with Gemcitabine and nab-paclitaxel in treatment of uPDAC and determine any adverse events.
4 secondary outcomes
Number of Patients with Adverse Events
Time frame: 2 years
Number of Patients who Discontinued Treatment Due to Reported Adverse Events
Time frame: 2 years
Objective Response Rate (ORR) by RECIST v1.1
Time frame: 2 years
Progression-Free Survival
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 4 May 2026.
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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.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
Jennifer Valerin, MD, PhD principal investigator
Chao Family 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 study testing Pitavastatin in people with Pancreatic Cancer and Pancreatic Cancer Metastatic, run by University of California, Irvine 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 15 inclusion and 16 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 4 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.
What does this 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.
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 Chao Family Comprehensive Cancer Center University of California, Irvine (1-877-827-8839, ucstudy@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase II Dose (time frame: 2 years). 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 4 May 2026.