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 tissue 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 tumour 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 dose of study medication. Women of childbearing potential must have a negative 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 consent.