Status:
UNKNOWN
Selecting Chemotherapy With High-throughput Drug Screen Assay Using Patient Derived Organoids in Patients With Refractory Solid Tumours (SCORE)
Lead Sponsor:
National University Hospital, Singapore
Conditions:
Organoids
HNSCC
Eligibility:
All Genders
21-99 years
Phase:
NA
Brief Summary
This is a single-centre study based on the Simon 2-stage optimax design: 12 patients will be enrolled initially (Stage I), which will then be expanded to a further 13 patients (Stage II) if 3 or more ...
Detailed Description
Investigators hypothesize that high-throughput screening on patient-derived tumour organoids can be used as an adjunct tool to aid treatment selection in patients with cancer. Using the IRS, drugs wit...
Eligibility Criteria
Inclusion
- Age ≥ 21 years.
- Histological or cytological diagnosis of head and neck squamous cell carcinoma (HNSCC), colorectal, breast or epithelial ovarian cancer.
- ECOG 0-1.
- At least 1 tumour lesion (primary or metastatic) amenable to fresh biopsy
- At least 1 measurable tumour lesions based on RECIST 1.1 criteria
- Estimated life expectancy of at least 12 weeks.
- Has documented progressive disease from last line of therapy.
- Able to wait at least 4 to 6 weeks before initiating the next line of anti-cancer therapy.
- Has received at least 2 line of palliative systemic therapy:
- (i) Breast cancer: must have received prior anthracyclines and taxanes in the neoadjuvant, adjuvant or palliative setting, unless either of these drugs were contraindicated due to organ dysfunction and/or comorbidities (ii) Ovarian cancer: must have received prior taxanes and platinums in the neoadjuvant, adjuvant or palliative setting (iii)HNSCC: must have received prior platinums, taxanes, and 5-fluorouracil in the neoadjuvant, adjuvant or palliative setting (iv)Colorectal cancer: must have received prior 5-fluorouracil, oxaliplatin and irinotecan in the neoadjuvant, adjuvant or palliative setting
- Adequate organ function including the following:
- (i)Bone marrow:
- Absolute neutrophil (segmented and bands) count (ANC) ≥ 1.5 x 109/L
- Platelets ≥100 x 109/L
- Hemoglobin ≥ 8 x 109/L
- (ii) Hepatic:
- Bilirubin ≤ 1.5 x upper limit of normal (ULN),
- ALT or AST ≤ 2.5x ULN,(or ≤ 5X with liver metastases)
- (iii) Renal:
- ◦Creatinine ≤ 1.5x ULN
- Signed informed consent from patient or legal representative.
- Able to comply with study-related procedures.
Exclusion
- Pace of cancer progression requiring commencement of anti-cancer therapy within 4 to 6 weeks.
- Treatment within the last 30 days with any investigational drug.
- Concurrent administration of any other tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
- Major surgery within 28 days of study drug administration.
- Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
- Pregnancy.
- Breast feeding.
- Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
- Active bleeding disorder or bleeding site.
- Non-healing wound.
- Poorly controlled diabetes mellitus.
- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- Symptomatic brain metastasis.
- History of significant neurological or mental disorder, including seizures or dementia.
Key Trial Info
Start Date :
May 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2022
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04279509
Start Date
May 29 2019
End Date
May 1 2022
Last Update
September 9 2020
Active Locations (1)
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1
National University Hospital
Singapore, Singapore