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:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT02607202
Eligibility Criteria:
Inclusion Criteria:
* Provision of written informed consent.
* Patients must be ≥ 18 years of age.
* Diagnosis of CUP according to CUP Diagnostic Guidelines derived from ESMO 2011 and NCCN 2015 guidelines.
* Sufficient archived biopsy tissue from a surgical or core needle biopsy required to perform the CUP multiplex assay.
* Eastern Cooperative Oncology Group performance status ≤ 2.
* No previous systemic therapy.
* At least one measurable lesion by RECIST Criteria.
* Good liver, cardiac, lung and marrow bone function.
* Evidence of non-childbearing status for female patients: negative urine or serum pregnancy test within 21 days of study treatment for women of childbearing potential, or postmenopausal status.
* Patients of child bearing potential and their partners, who are sexually active, must agree to the use of highly effective forms of contraception throughout their participation in the study.
* Patient is willing and able to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations.
Exclusion Criteria:
* Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, breast Ductal Carcinoma in Situ (DCIS), stage 1 grade 1 endometrial carcinoma.
* Specific treatable CUP syndromes including: extragonadal germ cell syndrome; neuroendocrine carcinoma; adenocarcinoma isolated to axillary lymph nodes (women cancer); peritoneal carcinomatosis (women - ovarian cancer); squamous carcinoma limited to cervical, supraclavicular, or inguinal lymph nodes; single resectable metastasis.
* Patients receiving any radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study entry.
* Patients with symptomatic uncontrolled brain metastases.
* Major surgery within 2 weeks of starting the study and patients must have recovered from any effects of any major surgery.
* Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 6 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
* Pregnant or breast feeding women.
* Immunocompromised patients, eg, patients who are known to be serologically positive for human immunodeficiency virus (HIV).
* Patients with known hepatic disease (eg, Hepatitis B or C).
* Previous cancer treatment.
* Patients currently enrolled in another clinical tria, except AGNOSTOS PROFILING.
* Patients that are receiving chemotherapy, hormonal therapy (HRT is acceptable) or other novel agents.
* Patients receiving live virus and bacterial vaccines.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02607202
Study Brief:
Protocol Section:
NCT02607202