Clinical trial NCT02734160 (phase 1, status: completed)
Conditions: metastatic pancreatic cancer
ICD codes: C25.3
Drugs: galunisertib, durvalumab
SMILES: CC1=CC=CC(=N1)C1=NN2CCCC2=C1C1=C2C=C(C=CC2=NC=C1)C(N)=O, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Must have histologic or cytologic confirmation of recurrent metastatic pancreatic
             adenocarcinoma based on standard diagnostic criteria. Recurrence must be documented by
             diagnostic biopsy.

          -  Have measurable disease as defined by Response Evaluation Criteria in Solid Tumours
             (RECIST) version 1.1.

          -  Have had disease progression, been refractory or intolerant to no more than 2 prior
             systemic regimens for locally advanced or metastatic pancreatic cancer. Participants
             who have received prior neoadjuvant therapy and who now have metastatic disease must
             have received 1 of the following for their metastatic disease: FOLFIRINOX,
             nanoparticle albumin-bound paclitaxel/gemcitabine, TS-1 (tegafur gimeracil oteracil
             potassium), irinotecan liposome injection/5-fluorouracil (5FU)/Leucovorin or
             single-agent gemcitabine prior to enrolment in this study.

          -  Dose Escalation: Able and willing to give valid written consent to undergo a new
             tumour biopsy (prior to study treatment) or to provide an available archival tumour
             sample if taken <3 years prior to enrolment if a new tumour biopsy is not feasible
             with an acceptable clinical risk.

          -  Cohort Expansion: Able and willing to give valid written consent to undergo a new
             tumour biopsy (prior to study treatment). Able and willing to undergo a second tumour
             biopsy on treatment. Where possible, tumour lesions used for new biopsies should not
             be the same lesions used as RECIST target lesions, unless there are no other lesions
             suitable for biopsy. Archival samples may be required if there is inadequate tissue in
             the biopsy specimen.

          -  Have adequate organ function.

          -  Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
             scale.

          -  Use approved contraceptive methods.

        Exclusion Criteria:

          -  Have moderate or severe cardiovascular disease:

               -  Have the presence of cardiac disease, including a myocardial infarction within 6
                  months prior to study entry, unstable angina pectoris, New York Heart Association
                  Class III/IV congestive heart failure, or uncontrolled hypertension.

               -  Have documented major electrocardiogram (ECG) abnormalities (not responding to
                  medical treatments; for example, atrial fibrillation, bundle branch blocks, or as
                  approved by the sponsors).

               -  Have major abnormalities documented by ECHO with Doppler (for example, moderate
                  or severe heart valve function defect including moderate or severe valve stenosis
                  or regurgitation, left ventricular ejection fraction <50%, evaluation based on
                  the institutional lower limit of normal, septal aneurysm or other heart aneurysm,
                  any aneurysm of the major vessels or any condition that results in increased risk
                  of aneurysm (eg, Marfan syndrome, patent foramen ovale [PFO]).

               -  Have predisposing conditions that are consistent with development of aneurysms of
                  the ascending aorta or aortic stress (for example, family history of aneurysms,
                  Marfan syndrome, PFO, bicuspid aortic valve, evidence of damage to the large
                  vessels of the heart documented by computerized tomography [CT] scan with
                  contrast or magnetic resonance imaging [MRI]).

          -  Have evidence of interstitial lung disease that is symptomatic or may interfere with
             the detection or management of suspected drug-related pulmonary toxicity or active,
             noninfectious pneumonitis.