PhIbRandomGemcitabine(G)w/or w/Out Pitavastatin(P)MainTx UnresecPancreaticAdenocarcinoma(uPDAC)

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT07549958
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pitavastatin — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Mar 24, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Pitavastatin, 1mg, Dose Level -1
    Pitavastatin will be dosed starting on cycle 1 day 1, once orally daily on days 1-28 every 4 weeks.
  • Experimental: Pitavastatin, 2 mg, Dose Level 0
    Pitavastatin will be dosed starting on cycle 1 day 1, once orally daily on days 1-28 every 4 weeks.
  • Experimental: Pitavastatin, 4 mg, Dose Level +1
    Pitavastatin will be dosed starting on cycle 1 day 1, once orally daily on days 1-28 every 4 weeks.

Primary Outcome Measure

Recommended Phase II Dose [ Time Frame: 2 years ]

Central Contacts

  • Chao Family Comprehensive Cancer Center University of California, Irvine
    1-877-827-8839
    [email protected]
  • University of California Irvine Medical

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center, University of California, IrvineOrangeCalifornia92868
Jennifer Valerin, MD, PhD
[email protected]
877-827-8839

Find similar trials in Orange, CA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Chao Family Comprehensive Cancer Center, University of California, Irvine· Orange, CA

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