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

Head and Neck Neoplasms Clinical Trial

Official title:

A Phase 1b Trial of LY2606368 in Combination With Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02555644
• Other study ID #: 16016
• Secondary ID: I4D-MC-JTJI2015-
• Status: Completed
• Phase: Phase 1
• Start date: February 24, 2016
• Est. completion date: January 14, 2019

Study information

• Verified date: February 1, 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 14, 2019
• Est. primary completion date: January 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Drug:
• Prexasertib
Administered IV
• Cisplatin
Administered IV
• Cetuximab
Administered IV

Radiation:
• Intensity Modulated Radiation Therapy

Locations

Country	Name	City	State
France	Centre Leon Berard	Lyon
France	Gustave Roussy	Villejuif Cedex
United States	University of Alabama at Birmingham Medical Center	Birmingham	Alabama
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Maximum Tolerated Dose of Prexasertib in Combination with Cisplatin and Radiation Therapy		First Dose through Last Dose (Estimated up to 7 Weeks)
Primary	Part B: Maximum Tolerated Dose of Prexasertib in Combination with Cetuximab and Radiation Therapy		First Dose through Last Dose (Estimated up to 8 Weeks)
Secondary	Pharmacokinetics (PK): Maximum Concentration of Prexasertib, Cisplatin and Cetuximab		First Dose through Last Dose (Estimated up to 8 Weeks)
Secondary	PK: Area Under the Concentration Curve (AUC) of Prexasertib		First Dose through Last Dose (Estimated up to 8 Weeks)
Secondary	Locoregional Control Rate		Baseline through One Year (Estimated as up to 52 Weeks) or Death from Any Cause

External Links

•   Click here for more information about this study: A Study of Prexasertib (LY2606368) with Chemotherapy and Radiation in Participants with Head and Neck Cancer