Phase
Condition
Digestive System Neoplasms
Metastatic Cancer
Treatment
IOA-289
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
≥18 years of age inclusive, at the time of signing the informed consent.
Capable of giving signed informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Patients with histologically or cytologically confirmed metastatic unresectablepancreatic adenocarcinoma.
Have measurable disease (≥ 1 measurable lesion) based on Response EvaluationCriteria In Solid Tumours (RECIST) v1.1 as determined by the site study team.
Eligible to receive 1st line systemic treatment with gemcitabine/nab-paclitaxel formetastatic disease.
Baseline CA19-9 levels are available from a sample acquired no more than 4 weeksprior to screening.
No prior systemic anti-cancer therapy for metastatic pancreatic cancer.
Male subjects with female partners of childbearing potential, and female subjects ofchild-bearing potential who had a negative serum pregnancy test at screening, mustagree to use a highly effective form of contraception (with at least 99% certainty)or avoid intercourse during and upon completion of the study and for at least 3months after the last dose of study drug.
Exclusion
Exclusion Criteria:
Inability to swallow food or any condition of the upper gastrointestinal tract thatprecludes administration of oral medications.
Have prior significant medical history and AEs:
Known active CNS metastases and/or carcinomatous meningitis.
History or presence of an abnormal ECG that, in the Investigator's opinion, isclinically meaningful. Screening QTc interval > 480 milliseconds is excluded (corrected by Fridericia).
Known additional malignancy that is progressing or requires active treatment.Patients with active malignancy requiring concurrent intervention or previousmalignancies (for example non-melanoma skin cancers, and in situ cancers:bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma or breast)unless a complete remission was achieved at least 2 years prior to study entryand no additional therapy is required during the study period.
Any serious or uncontrolled medical disorder or active infection that, in theopinion of the Investigator, may increase the risk associated with studyparticipation, study drug administration, or would impair the ability of thepatient to receive protocol therapy.
Treatment with anticancer medications, investigational drugs, surgery and/orradiation within the following interval before the first administration of studydrug:
< 14 days for chemotherapy, targeted small-molecule therapy, surgical resectionof lesions or radiation therapy (prior palliative radiotherapy must have beencompleted at least 14 days prior to study drug administration). A 1-weekwashout is permitted for palliative radiation to non-CNS disease with Sponsorapproval.Note: The use of denosumab against osteoporosis is permitted.
< 28 days for prior monoclonal antibody used for anticancer therapy with theexception of PD-1 pathway-targeted agents.
< 28 days or 5 half-lives (whichever is longer) before the first dose for allother investigational study drugs or devices. For investigational agents withlong half-lives (e.g., > 5 days), enrolment before the fifth half-life requiresMedical Monitor approval.
Receiving an immune-suppressive based treatment for any reason (including chronicuse of systemic corticosteroid at doses > 10 mg/day prednisone equivalent) within 14days prior to the first dose of study treatment (see the exception for CNS lesionsdescribed in 2a). Use of inhaled or topical steroids or brief corticosteroid use forradiographic procedures or systemic corticosteroids ≤ 10 mg is permitted.
Have received a live vaccine within 30 days of planned start of study therapy.
Have not recovered from toxic effect(s) of prior therapy to ≤ Grade 1, other thanalopecia or fatigue.
Known allergy or reaction to any component of either study drug or formulationcomponents.
Currently breastfeeding.
Known alcohol or other substance abuse.
Laboratory and medical history parameters not within Protocol-defined range.Absolute neutrophil count < 1.5 × 109/L.
Platelet count < 100 × 109/L.
Haemoglobin < 8 g/dL (transfusion is acceptable to meet this criterion).
Serum creatinine ≥ 1.5 × institutional ULN or measured or calculated creatinineclearance (glomerular filtration rate can also be used in place of creatinineor CrCl) < 50 mL/min for patients with creatinine levels > 1.5 × institutionalULN.
Aspartate aminotransferase, ALT, and alkaline phosphatase (ALP) ≥ 2.5 × ULN.Note: Patients with 1) bone metastases and 2) no hepatic parenchymal metastaseson screening radiographic examinations may enrol if the ALP is < 5 × ULN.Patients with 1) bone metastases and 2) hepatic parenchymal metastases onscreening radiographic examinations may enrol if the ALP is < 5 × ULN only withMedical Monitor approval.
Total bilirubin ≥ 1.5 × ULN are excluded unless direct bilirubin is ≤ ULN. Ifthere is no institutional ULN, then direct bilirubin must be < 40% of totalbilirubin to be eligible (except patients with Gilbert syndrome - see Notebelow)
International normalized ratio or prothrombin time (PT) > 1.5 × ULN.
Activated partial thromboplastin time (aPTT) > 1.5 × ULN.
Evidence of acute infection of hepatitis B virus (HBV), hepatitis C virus (HCV)and HIV. Patients who are on stable antiviral therapy and/or asymptomatic areeligible for the study.
Study Design
Connect with a study center
Medical Oncology and Immunotherapy Unit, University Hospital of Siena
Siena, 53100
ItalySite Not Available
UO Oncologia of Azienda Ospedaliera Universitaria Integrata di Verona
Verona, 37126
ItalySite Not Available
Beatson West of Scotland Cancer Center
Glasgow, G12 0YN
United KingdomSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.