PhIbRandomGemcitabine(G)w/or w/Out Pitavastatin(P)MainTx UnresecPancreaticAdenocarcinoma(uPDAC)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Irvine
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Pitavastatin
Treatment groups
18 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov