A phase 2, open-label, single-arm sulfasalazine monotherapy trial of progression-free survival in patients with pancreatic adenocarcinoma

ACTRN 12621001347853

Brief Summary

This study will assess the anti-cancer activity of sulfasalazine in patients with advancedat a late stage, far along or metastatic pancreatic ductal adenocarcinomacancer arising from mucus-producing glands in organs.

Intervention/Treatment

• Drug: Sulfasalazine

Inclusion Criteria

1. Aged >=18 years old.
2. Histologically or cytologically confirmed locally advanced (Stage III) unresectable or metastatic (Stage IV) PDAC.
3. Adequate archival tissuea group of cells that work together to perform a function for comprehensive genomic profiling.
4. Disease must have progressed after one-line of standard fluoropyrimidine- or gemcitabine-based chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells for advanced disease. Treatment break within the upfront chemotherapy regimen is considered the same line of therapy and is permitted.
5. Have had one-line of systemic therapy for advanced disease. Patients who have had two lines of systemic therapy or are intolerant of second-line treatment may be eligible after consultation with the study Chief Investigators.
6. ECOG performance status score of 0-1.
7. Life expectancy >12 weeks.
8. Measurable disease as defined by RECIST version 1.1.
9. Presence of tumoura tissue mass that forms from groups of unhealthy cells amenable to a second biopsyremoval of a section of tissue to analyse for cancer cells.
10. Adequate haematological indices as defined by:
    • Absolute neutrophil count >=1.0 x 10^9/L.
    • Haemoglobin >=100 g/L.
    • Platelet count >=100 x 10^9/L.
    • Bilirubin <1.5x ULN.
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <1.5x ULN; or <5.0x ULN if liver metastases are present.
    • International normalised ratio (INR) <1.3 in the absence of anticoagulation therapy.
11. Adequate renal function, as defined by Creatinine Clearance (CrCl) >=50mL/min using Cockcroft formula.
12. Women of childbearing potential and men must use effective contraception during the study and for at least 90 days after the last dosethe amount of medication taken of study medication. Women of childbearing potential must have a negative screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening serum pregnancy test.
13. Ability to adhere to the study visit schedule and understand and comply with all protocol requirements and instructions from study staff.
14. Provision of written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment..