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 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT06309732
Eligibility Criteria:
Inclusion Criteria:
* Germ Cell Tumour (GCT), relapsed or progressing on or following platinum-based chemotherapy - as evidenced by rising tumour markers or progressive disease on CT scan
* Neutrophil count \>1.0 x109/l
* Platelets \>70 x109/l
* Haemoglobin \>100g/l (may be transfused)
* Creatinine clearance should be \>60ml/min. However, if creatinine clearance \<60 ml/min then an EDTA clearance is MANDATORY. (If EDTA clearance is \<60 ml/min then the patient will be excluded.)
* Males age \>16 ≤35 years \[decision made on physical fitness to participate\]
* ECOG Performance status 0-3
* Full written consent
Exclusion Criteria:
* Other malignancy except basal cell carcinoma
* Evidence of clinically significant cardiac failure, unstable angina or uncontrolled hypertension
* Current participation in any other investigational drug study
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
16 Years
Maximum Age:
35 Years
Study:
NCT06309732
Study Brief:
Protocol Section:
NCT06309732