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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT01172769
Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent must be given prior to study inclusion
* Histological or cytological confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC)
* Measurable progressive disease after platinum-based radiochemotherapy or recurrence or metastatic progressive disease after 1st line platinum-based chemotherapy
* Patients with loco-regional recurrence need to be progression free for at least 6 months after platinum-based radiochemotherapy, if locoregional recurrence is the only lesion
* Cetuximab must have been included in at least one prior line of therapy
* Disease is not amenable to surgery, radiotherapy or platinum-based chemotherapy
* At least one measurable lesion according to RECIST (Version 1.0) criteria
* Age \> 18 years
* ECOG performance status 0-2
* Brain metastases require completion of local therapy with discontinuation of steroids prior to start of treatment
* If of childbearing potential, willingness to use effective contraceptive method (double barrier method) for the study duration and 2 months after last dose
* Willingness and ability to comply with the protocol
* Adequate bone marrow function, liver and renal function
Exclusion Criteria:
* Live expectancy less than 3 months
* Anticancer treatment during the last 30 days prior to start of treatment, including systemic therapy, radiotherapy or major surgery
* Participation in a clinical trial within the last 30 days prior to study treatment
* Serious illness or medical condition other than the disease under study
* Other malignancies within 3 years, with exception of HNSCC, history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
* Inability to potentially complete follow up and treatment per protocol for psychological, familial, sociological or geographical reasons
* Pregnancy or breast feeding
* Known allergic/hypersensitivity reaction to any component of the treatment
* Concurrent treatment with oral anticoagulants
* Uncontrolled diabetes: fasting serum glucose \> 2.0 ULN
* Active or uncontrolled infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01172769
Study Brief:
Protocol Section:
NCT01172769