Trial purpose
Cancer treatment
Tumor type
Upper gastrointestinal tract
Age
18+
Clinical summary
Summary
Participants will commence treatment with sulfasalazine (500mg oral tablets) at 1.5g per day in three evenly divided doses. The dose will be increased in stages to the target dose of 4.5g per day. The dose may be further increased to 6g per day if there are no significant intolerances and with researcher approval. How quickly the doses are increased will depend on each participant's acetylator status, which affects how quickly sulfasalazine is processed in the body.
Conditions
This trial is treating people with locally advanced (Stage III) inoperable, or metastatic (Stage IV) pancreatic ductal adenocarcinoma
Eligibility
Inclusion
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:
a. Absolute neutrophil count >=1.0 x 10^9/L
b. Haemoglobin >=100 g/L
c. Platelet count >=100 x 10^9/L
d. Bilirubin <1.5x ULN
e. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <1.5x ULN; or <5.0x ULN if liver metastases are present
f. 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.
Exclusion
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.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You are able to swallow medication by mouth.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Australian Genomic Cancer Medicine Centre Ltd t/a Omico
Scientific Title
A phase 2, open-label, single-arm sulfasalazine monotherapy trial of progression-free survival in patients with pancreatic adenocarcinoma
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