Study Condition(s): Head and Neck Cancer

A Study of LY2606368 with Chemotherapy and Radiation in Participants with Head and Neck Cancer

Study Alias: JTJI

Study Identifier(s): Tool Tip Icon {{ defaultRegistry.registryAnchorText }} NCT02555644 {{ currentLocaleObject.registryAnchorText }}

Study Purpose

The main purpose of this study is to investigate the safety of LY2606368 in combination with other anti-cancer drugs (cisplatin or cetuximab) and radiation therapy in participants with locally advanced head and neck cancer. The study has two parts (A: cisplatin+LY2606368+radiation therapy and B: cetuximab+ LY2606368+radiation therapy) Participants will only enroll in one part. Participants in the United States may enroll in either Part A or Part B. Participants in France may only enroll in Part A.

Key Participation Requirements Tool Tip Icon

All clinical trials have rules about who can participate. This section outlines some of those rules. Please contact a study center to discuss the full set of criteria

Gender

Male Female

Age

18+ years

Time Commitment

Your participation will last ~ 7-8 weeks depending on how well you tolerate therapy. There is also a follow up period of ~ 1 year.
  • Participant must have a diagnosis of head and neck squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls), hypopharynx, or larynx

  • Participants of reproductive potential must agree to use medically approved contraceptive precautions during the study and for three months following the last dose of study drug

  • Female participants of childbearing potential must have negative pregnancy test and must not be breast feeding

  • Participant must not have received any of the following prior therapies or treatments: systemic therapy for the head and neck cancer, radiation therapy to the head and neck region, or curative-intent surgery in the head and neck region

  • Participant must not have an active symptomatic fungal, bacterial or viral infection, including HIV or Hepatitis A, B, or C

  • Participant must not have a serious heart condition, such as congestive heart failure, unstable angina pectoris, or have had a heart attack within the last three months

Where to Participate

4 locations are currently available of 5 planned
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