A Study of Prexasertib (LY2606368) With Chemotherapy and Radiation in Participants With Head and Neck Cancer

Lilly

Status and phase: Completed; Phase 1

Conditions: Head and Neck Neoplasms

Treatments: Drug: Prexasertib; Radiation: Intensity Modulated Radiation Therapy; Drug: Cisplatin; Drug: Cetuximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02555644

I4D-MC-JTJI (Other Identifier)

2015-001215-12 (EudraCT Number)

16016 (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to investigate the safety of prexasertib 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 and B). Participants will only enroll in one part.

Full description

The primary purpose of Parts A and B of this study is to determine a recommended dose level of prexasertib (an inhibitor of checkpoint kinase 1[Chk-1]) in combination with cisplatin and radiation therapy (Part A) or cetuximab and radiation therapy (Part B) in participants with locally advanced head and neck cancer.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be able to comply with the treatment plan and follow-up schedule
• Must have diagnosis of head and neck squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls), hypopharynx, or larynx
• Have adequate organ function
• If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for six months following the last dose of study drug
• If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 14 days of the first dose of study drug and must not be breast feeding

Exclusion criteria

• Must not have taken an unapproved drug as treatment for any indication within the last 28 days prior to starting study treatment
• Must not have received any of the following prior therapies or treatments: systemic therapy for the study cancer, radiation therapy to the head and neck region, or curative-intent surgery in the head and neck region
• Have evidence of a distant metastatic disease
• Must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C
• Must not have a serious heart condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last three months
• Must not have a family history of long corrected QT interval (QTc) syndrome
• Must not have known allergic reaction against any of the components of the study treatment

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Prexasertib + Cisplatin + Radiation Therapy (Part A)

Experimental group

Description:

Prexasertib administered intravenously (IV) every 14 days over an approximately 49-day treatment period. Cisplatin administered IV every 7 days over an approximately 49-day treatment period. Intensity modulated radiation therapy administered 5 days per week over an approximately 49-day treatment period. Participants may remain on treatment until completion of the treatment period.

Treatment:

Drug: Cisplatin

Radiation: Intensity Modulated Radiation Therapy

Drug: Prexasertib

Prexasertib + Cetuximab + Radiation Therapy (Part B)

Experimental group

Description:

Prexasertib administered IV every 14 days over an approximately 56-day treatment period. Cetuximab administered IV every 7 days over an approximately 56-day treatment period. Intensity modulated radiation therapy administered 5 days per week over an approximately 56-day treatment period (starting at Week 2). Participants may remain on treatment until completion of the treatment period.

Treatment:

Drug: Cetuximab

Radiation: Intensity Modulated Radiation Therapy

Drug: Prexasertib