Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT02051868
Eligibility Criteria:
Inclusion Criteria
1. Histologically or cytologically verified, uni-dimensionally measurable, inoperable, locally recurrent or metastatic squamous cell carcinoma of the anus.
2. Age ≥18 years.
3. ECOG Performance status ≤2.
4. Measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1.
5. Previous definitive chemoradiotherapy is permitted for early stage squamous cell carcinoma of the anus.
6. HIV+ patients will be considered eligible with a CD4 count of ≥200.
7. Adequate cardiac and respiratory function; absolute neutrophil count (ANC) ≥1.5x10\^9/l; white blood cell (WBC) count ≥3x10\^9/l; platelets \>100x10\^9/l; haemoglobin (Hb) ≥9g/dl; creatinine clearance \>50ml/minute; serum bilirubin ≤1.5x upper limit of normal (ULN); alanine transaminase (ALT)/aspartate transaminase (AST) ≤2.5x ULN; alkaline phosphatase (ALP) ≤3x ULN.
8. Fertile men and women must agree to take adequate contraceptive precautions during, and for at least six months after therapy.
9. Life expectancy of at least 3 months.
Exclusion Criteria
1. Tumours of adenocarcinoma, melanoma, small cell and basal cell histology are excluded.
2. Previous chemotherapy, radiotherapy or other investigational drug for surgically unresectable locally recurrent or advanced squamous cell carcinoma of the anus
3. Current or recent (within 30 days of first study dosing) treatment with another investigational drug or participation in another investigational study.
4. Documented or symptomatic brain metastases and/or central nervous system metastases or leptomeningeal disease.
5. Surgery or palliative radiotherapy within 28 days of randomisation.
6. Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary artery disease, uncontrolled cardiac arrhythmia, or myocardial infarction within the last 6 months). Any history of clinically significant cardiac failure.
7. History of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan.
8. Lack of physical integrity of the gastro-intestinal tract, malabsorption syndrome (naso-gastric or jejunostomy feeding tube is permitted).
9. Acute hepatitis C and/or chronic active hepatitis B infection.
10. Serious active infection requiring i.v. antibiotics at enrolment.
11. Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
12. Other clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this trial.
13. Known hypersensitivity to any of the study drugs or excipients.
14. Known peripheral neuropathy ≥ grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible).
15. Pre-existing hearing impairment.
16. Patients planning for a live vaccine.
17. Pregnant or lactating females.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02051868
Study Brief:
Protocol Section:
NCT02051868