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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-24

Study Completion Date

2019-01-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Head and Neck Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prexasertib + Cisplatin + Radiation Therapy (Part A)

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.

Group Type EXPERIMENTAL

Prexasertib

Intervention Type DRUG

Administered IV

Cisplatin

Intervention Type DRUG

Administered IV

Intensity Modulated Radiation Therapy

Intervention Type RADIATION

Prexasertib + Cetuximab + Radiation Therapy (Part B)

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.

Group Type EXPERIMENTAL

Prexasertib

Intervention Type DRUG

Administered IV

Cetuximab

Intervention Type DRUG

Administered IV

Intensity Modulated Radiation Therapy

Intervention Type RADIATION

Interventions

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Prexasertib

Administered IV

Intervention Type DRUG

Cisplatin

Administered IV

Intervention Type DRUG

Cetuximab

Administered IV

Intervention Type DRUG

Intensity Modulated Radiation Therapy

Intervention Type RADIATION

Other Intervention Names

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LY2606368 Erbitux LY2939777

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No