Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amplia Therapeutics Limited
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Provide written informed consent prior to any study procedures and agree to adhere to all protocol requirements.
2. Aged at least 18 years at the time of consent.
3. Confirmed histological or cytological diagnosis of advanced pancreatic adenocarcinoma that is:
Part A: metastatic or not surgically resectable.
Part B: metastatic, with initial diagnosis of metastatic disease ≤6 weeks prior to Baseline.
4. Has measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral CT scan.
5. Eligible for treatment with nab-paclitaxel and gemcitabine as standard of care therapy.
6. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1, sustained on two separate assessments: the first at least 2 weeks prior to the 1st dose of AMP945 and the 2nd within 72 hours prior to the 1st dose of AMP945. Participants not maintaining an ECOG Performance Score of 0-1 at the second assessment will be excluded from participation.
7. Has a life expectancy of \>3 months.
8. Adequate organ function, as defined by the laboratory results below (samples must be obtained ≤14 days prior to study drug administration):
a) Haematology:
(i) Absolute neutrophil count (ANC) ≥1.5 × 109/L;
(ii) Platelet count ≥100,000/mm3 (100 × 109/L);
(iii) Haemoglobin (Hgb) ≥9 g/dL.
b) Serum chemistry:
(i) Aspartate transaminase (AST) (SGOT), ALT (SGPT) ≤2.5 × upper limit of normal range (ULN), unless liver metastases are clearly present, then ≤5 × ULN is allowed;
(ii) Total bilirubin ≤ULN;
(iii) Creatinine \<1.5 x upper limit of normal (ULN) or estimated glomerular filtration rate (eGFR) \>60 mL/min/1.73m2 (calculated using the Cockcroft-Gault equation).
c) No clinically significant abnormalities in coagulation results.
d) No clinically significant abnormalities in urinalysis results.
9. Agree to use contraception according to protocol
You may not be if
1. Pregnant or breast-feeding, or plans to become pregnant during the study.
2. Has received any investigational medicinal product (IMP) within 30 days or 5 half-lives (whichever is longer) prior to Day -8.
3. Known brain metastases, unless previously treated and well-controlled for at least 3 months (defined as clinically stable, no oedema, no steroids and stable in 2 scans at least 4 weeks apart).
4. Gastrointestinal condition that could interfere with the swallowing or absorption of study medication.
5. Part A: Has received prior systemic treatments for pancreatic cancer, except those given in the adjuvant setting, and with recurrence more than 6 months after completion of curative/adjuvant treatment.
7. History of malignancy other than in situ cancer or basal or squamous cell skin cancer in the last 5 years.
8. Major surgery, other than diagnostic surgery (i.e., surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day -8.
9. Known human immunodeficiency virus (HIV) and/or history of Hepatitis B or C infections or known to be positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C Antibody.
10. Known history of myocardial infarction, coronary stenting, stroke, or cerebrovascular accident within 6 months prior to the first dose of study drug.
11. Focal palliative radiotherapy (e.g., to a bony metastasis) within the 14 days prior to Run-in, or more extensive radiotherapy within 28 days prior to Run-in.
12. History of chronic leukemias (e.g., chronic lymphocytic leukemia).
13. History of interstitial lung disease, history of slowly progressive dyspnoea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies.
14. History of connective tissue disorders (e.g., lupus, scleroderma, arteritis nodosa).
15. Clinical signs of active infection and/or a temperature of \> 38.0°C at the time of Screening or Baseline. Study entry may be deferred at the discretion of the Principal Investigator (PI).
16. Currently using warfarin.
17. Administration of a live virus vaccine in the 4 weeks prior to Day -8 or plans to receive a live virus vaccine during the study.
18. Clinically significant allergies to AMP945, nab-paclitaxel or gemcitabine (or any of their excipients), including hypersensitivity reactions to human albumin, that are not likely to be well controlled with premedication or other supportive measures.
19. Exhibiting any of the conditions or events outlined in the Contraindications or Special Warnings and Precautions sections of the nab-paclitaxel and/or gemcitabine package inserts.
20. Peripheral neuropathy \> Grade 1.
21. Corrected QT interval using Fridericia's correction (QTcF) \> 460 ms for males and \>480 ms for females.
22. Any clinically relevant medical, social, or psychiatric conditions, or any finding during Screening, which in the Investigator's opinion may put the participant at unacceptable risk or interfere with the study objectives.
