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

ConditionsPancreatic CancerPancreatic Cancer Metastatic
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Pitavastatin

    Drug

    Given PO

Treatment groups

18 Participants
are divided into 3 treatment groups
Group A: Pitavastatin, 1mg, Dose Level -1Experimental treatment 1 intervention
Group B: Pitavastatin, 2 mg, Dose Level 0Experimental treatment 1 intervention
Group C: Pitavastatin, 4 mg, Dose Level +1Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2 years

Secondary outcomes

1

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.

Time frame
2 years
2

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.

Time frame
2 years
3

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.

Time frame
2 years
4

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.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Irvine

Lead sponsor

Source ClinicalTrials.gov
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