Trial summary: This study evaluates the anti-cancer activity of sulfasalazine in patients with advanced or metastatic pancreatic ductal adenocarcinoma whose cancer has progressed after standard treatments. The primary aim is to assess progression-free survival (PFS) over 6 months. Secondary outcomes include tumour response, overall survival, and treatment safety.
Status: OPEN - Recruiting
Trial identifier: ACTRN12621001347853
Sponsor: Australian Genomic Cancer Medicine Centre Ltd t/a Omico
Phase: II
Diagnosis: Locally advanced (Stage III) unresectable or Metastatic (Stage IV) pancreatic ductal adenocarcinoma
Line of therapy: Second-line +
Treatment: Sulfasalazine monotherapy (oral)
  • Key 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 chemotherapy 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 biopsy.
    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.
  • Key exclusion criteria
    1. Diagnosis of other histology types other than ductal adenocarcinoma, including but not limited to pancreatic acinar cell carcinoma, well-differentiated neuroendocrine tumour, neuroendocrine carcinoma, or lymphoma. Mixed histology with predominantly adenocarcinoma component is eligible.
    2. Uncontrolled diabetes, defined as HbA1c >10% in previous 3 weeks.
    3. Pregnant or breastfeeding.
    4. Major surgery within 28 days prior to Day 1. Biliary stent placement or endoscopic procedure is permitted.
    5. Radiation therapy within 28 days prior to Day 1.
    6. Uncontrolled central nervous system or brain metastases.
    7. Uncontrolled hypertension (systolic blood pressure [SBP] >180mmHg or diastolic blood pressure [DBP] >105mmHg).
    8. New York Heart Association Class III or IV congestive heart failure.
    9. Current clinical or laboratory evidence of active or uncontrolled infection.
    10. History of uncontrolled severe asthma or atopic dermatitis requiring hospitalization.
    11. Concomitant advanced solid or haematological malignancy with an expected prognosis that is worse than the index pancreatic adenocarcinoma.
    12. Active major gastrointestinal bleeding.
    13. Known hypersensitivity or allergic reactions to salicylates or sulphonamide derivatives, including antibacterial sulphonamides, oral hypoglycaemics, and thiazides.
    14. Known intestinal or urinary obstruction or porphyria.
    15. Participation in studies of investigational products within 28 days prior to Day 1, or 5 half-lives, whichever is longer.
    16. Clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study or a likelihood that the potential participant will be unable to comply with protocol requirements and complete the trial (e.g., emphysema requiring supplemental oxygen, poorly controlled arrhythmia, psychiatric illness, Alzheimer's disease).
    17. Current abuse of alcohol or drugs.

SPEAR

Locations: Epworth Richmond, Epworth Freemasons (East Melbourne).

Epworth PI: Dr Allan Zimet

Jreissati Pancreatic Centre at Epworth 

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