Azacitidine for Breast and Gastrointestinal Cancers
Optimizing and Personalising Azacitidine Combination Therapy for Treating Solid Tumours QPOP and CURATE.AI
Recruiting
Phase 1Phase 2Interventional Study
Solid TumorGastrointestinal CancerBreast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
21 – 99
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
10 (estimated)
Sponsor
National University Hospital, Singapore · Other
Who this trial is looking for
This trial is looking for adults with breast or gastrointestinal cancer. Participants will receive a personalized treatment combining a medication called azacitidine with other drugs based on their individual responses.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 21 years old.
I have been diagnosed with breast or gastric cancer.
I have a good performance status (ECOG 0 to 2).
I have a specific set of lab test results that meet the study's criteria.
I have undergone a previous drug screen that showed potential benefit from azacitidine therapy.
I have elevated response markers in my test results.
You may not be able to join if
I am pregnant or breastfeeding.
I am allergic to any of the drugs in the treatment.
I have a serious medical or psychiatric condition that affects my ability to participate.
I have had major surgery in the past 28 days.
I have uncontrolled heart failure or recent heart problems.
I have had chemotherapy with certain drugs in the past without meeting criteria.
I have a condition known as Gilbert's syndrome with specific drugs.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This pilot feasibility study aims to set the foundation to investigate the applicability of QPOP drug selection followed by CURATE.AI-guided dose optimisation of the selected azacitidine combination therapy for solid tumours using CURATE.AI within the current clinical setting.
QPOP will identify drug interactions towards optimal efficacy and cytotoxicity from the pre-specified drug pool based on …
This pilot feasibility study aims to set the foundation to investigate the applicability of QPOP drug selection followed by CURATE.AI-guided dose optimisation of the selected azacitidine combination therapy for solid tumours using CURATE.AI within the current clinical setting.
QPOP will identify drug interactions towards optimal efficacy and cytotoxicity from the pre-specified drug pool based on ex vivo experimental data from the individual participant's tissue sample model. With these drug interactions, QPOP will identify the optimal drugs for the specific participant whose biopsy provided the cells for the ex vivo experimentation. Subsequently, CURATE.AI will be used to guide dosing for the selected combination therapy for that participant.
Individualised CURATE.AI profiles will be generated based on each participant's response to a set of drug doses. Subsequently, the personalised CURATE.AI profile will be used to recommend the efficacy-driven dose. CURATE.AI will operate only within the safety range for each drug pre-specified for each participant.
This pilot feasibility study will inform the investigators on the logistical and scientific feasibility of performing a large-scale randomised controlled trial (RCT) with the selected azacitidine combination therapy regimens and response markers. A secondary objective is to collect toxicity and efficacy data using established and exploratory response markers within and in-between cycles as exploratory outcomes.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. Males and females ≥ 21 years of age.
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
3. Patients must meet the following clinical laboratory criteria within 21 days of starting treatment:
1. Absolute neutrophil count (ANC) ≥ 1,000/mm3 and platel…
Inclusion Criteria:
1. Males and females ≥ 21 years of age.
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
3. Patients must meet the following clinical laboratory criteria within 21 days of starting treatment:
1. Absolute neutrophil count (ANC) ≥ 1,000/mm3 and platelet ≥ 50,000/mm3
2. Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN of ≤ 5 ULN if involvement of the liver.
3. Calculated creatinine clearance ≥ 30 mL/min or creatinine \< 1.5 x ULN.
4. Diagnosed with breast or gastric cancer, where docetaxel, paclitaxel or irinotecan is indicated for palliative therapy.
5. Patients who have undergone QPOP drug screen (e.g. under QGAIN (2019/00924) or NGAIN trial (2021/00009) where the drug screen indicated potential benefit of combining azacitidine with taxane or irinotecan.
6. Patients must have raised response marker above upper limit of local laboratory normal (e.g. CEA and/or CA19-9, CA 15-3, CA 125, AFP, and methylation markers such as but not limited to DNMT).
Exclusion Criteria:
1. Patients who are lactating or pregnant.
2. Patients with clinically significant hypersensitivity to one or more of the selected regimen's constituent drug(s) (e.g. patients with clinically significant hypersensitivity to irinotecan may not be enrolled on azacitidine + irinotecan, but may be allowed on azacitidine + paclitaxel or azacitidine + docetaxel).
3. Contraindication to any of the required concomitant drugs or supportive treatments.
4. Any clinically significant medical disease or psychiatric condition that, in the co-investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.
5. Major surgery within 28 days prior to start of the treatment.
6. Active congestive heart failure (New York Heart Association \[NYHA\] Class III or IV), symptomatic ischaemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 4 months prior to informed consent obtained.
7. Patients who previously underwent chemotherapy treatment with either docetaxel, paclitaxel and/or irinotecan may still be able to enrol into treatment with the same drug in combination with azacitidine provided they fulfil all other criteria and approval is sought by PI and Sponsor (e.g. patients previously treated with paclitaxel and are enroling for treatment with paclitaxel + azacitidine).
8. Patients with clinical suspicion or diagnosis of Gilbert's syndrome will not be allowed to enrol with azacitidine + irinotecan, but may be allowed to enrol for treatment with azacitidine + docetaxel or azacitidine + paclitaxel provided they fulfil all other criteria.
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