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 @ 3:23 PM
Ignite Modification Date:
2025-12-24 @ 3:23 PM
NCT ID:
NCT01458392
Eligibility Criteria:
Key Inclusion Criteria:
* Histologically and/or cytologically confirmed, recurrent or metastatic SCCHN of mucosal origin (oral cavity, oropharynx, hypopharynx or larynx) not amenable to further local therapy (surgery, or radiation including re-irradiation); patients with unknown primary SCCHN presumed to be of head and neck mucosal origin are eligible if they meet all other entry criteria.
* Previously treated with at least one platinum-containing regimen or contraindicated for treatment with a platinum containing therapy. (Note: platinum therapy can occur upfront or after recurrence of disease. Failure of platinum therapy is not required.)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key Exclusion Criteria:
* Nasopharyngeal carcinoma, paranasal sinus, salivary gland or primary skin SCCHN.
* Any other active malignancy for which chemotherapy or other anti-cancer therapy is indicated.
* Chemotherapy or other anti-cancer therapy or radiation therapy within 5 times the half-life of the drug or within 3 weeks prior to study day 1 if the half-life is not known.
* Treatment with another investigational drug or device, or approved therapy for investigational use, within 5 times the half-life of the drug or within 3 weeks prior to study day 1 if the half-life is not known.
* Major surgery within 4 weeks prior to study day 1 (patients must have recovered completely from any previous surgery prior to study day 1).
* Clinically significant cardiovascular risk.
* Clinically significant active pulmonary risk.
* Clinically significant active bleeding.
* Peripheral edema ≥ Grade 1 within 4 weeks prior to study day 1.
* Pregnant or lactating female patients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01458392
Study Brief:
Protocol Section:
NCT01458392