The AIM-HN and SEQ-HN Study: A 2 Cohort Non-comparative Pivotal Study Evaluating the Efficacy of Tipifarnib in Patients with Head and Neck Squamous Cell Carcinoma (HNSCC) with HRAS Mutations (AIM-HN) and the Impact of HRAS Mutations on Response to First Line Systemic Therapies for HNSCC (SEQ-HN)

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Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Head And Neck Squamous Cell Carcinoma (hnscc) With Hras Mutations (aim-hn)
Age: Between 18 years - 100 years
Gender: Male or Female

Other Inclusion Criteria:

1) Histologically confirmed head and neck cancer (oral cavity, pharynx, larynx, sinonasal, nasopharyngeal, or unknown primary) of squamous histology not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy). 2) Documented tumor progression or recurrence from at least one prior platinum-containing regimen in the primary, neoadjuvant, adjuvant, advanced, recurrent or metastatic setting. 3) Known tumor missense HRAS mutation. HRAS status may be assessed on tumor obtained at primary diagnosis or at later stages of disease.

1) Histologically confirmed salivary gland, thyroid, (primary) cutaneous squamous or nonsquamous histologies (e.g. mucosal melanoma). A subject may not be enrolled in the tipifarnib treatment portion of the study (AIM-HN): 1) Has disease that is suitable for local therapy administered with curative intent. 2) Prior treatment (at least 1 full treatment cycle) with a farnesyltransferase inhibitor (FTI). 3) Ongoing treatment with an anticancer agent not contemplated in this protocol.