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 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT01427205
Eligibility Criteria:
Inclusion Criteria:
1. Patients must have histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx.
2. Patients must be willing to have a biopsy of tumor tissue for biomarker analysis.
3. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>/= 20 mm with conventional techniques or as \>/= 10 mm with spiral computed tomography (CT) scan or magnetic resonance imaging (MRI). Measurable lymph nodes are required to be \>/= 15 mm in size (short axis diameter). Measurable disease in previously radiated areas is acceptable as long as there has been documented progression.
4. Patients must have disease progression: 1) After platinum-based chemotherapy for recurrent/metastatic disease OR 2) Within 6 months of receiving definitive platinum-based combined modality therapy.
5. Previous treatment with cetuximab is allowed, as long as there has been a period \>/= 6 months between the last cetuximab treatment and randomization
6. All prior cytotoxic therapy must have been completed at least three weeks prior to treatment on study.
7. Age \>/= 18 years
8. ECOG performance status \</= 2 or Karnofsky \>/= 60%
9. Patients must have normal liver function as defined below: total bilirubin \</= institutional upper limit of normal and aspartate aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) \</= 2.5 \* institutional upper limit of normal.
10. Patients - both males and females - with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.
11. Patients must provide verbal and written informed consent to participate in this study
12. Prior radiation treatment is acceptable as long as it has been completed one week prior to treatment on protocol.
Exclusion Criteria:
1. Patients may not be receiving any other investigational agents with anti-cancer activity.
2. Patients with known, untreated brain metastases. Patients with treated (irradiated or resected) brain metastases are eligible if treatment was completed \>/= 28 days prior to study entry and if clinical neurologic function is stable.
3. History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-906 or other agents used in the study.
4. QTc interval \> 450 msec at baseline.
5. Concomitant drugs with a generally accepted risk of causing Torsades de Pointes
6. Congestive heart failure, New York Heart Association (NYHA) Class III or IV
7. History of arrhythmia which is symptomatic and requires treatment, or asymptomatic sustained ventricular tachycardia. Patients with atrial fibrillation controlled on medication are not excluded.
8. Fasting blood sugar \> 150 mg/dl at baseline
9. Serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, in the opinion of the treating physician.
10. Pregnant or breast-feeding females.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01427205
Study Brief:
Protocol Section:
NCT01427205