- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02555644
A Study of Prexasertib (LY2606368) With Chemotherapy and Radiation in Participants With Head and Neck Cancer
A Phase 1b Trial of LY2606368 in Combination With Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Lyon, France, 69008
- Centre Leon Berard
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Villejuif Cedex, France, 94805
- Gustave Roussy
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-
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Alabama
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Birmingham, Alabama, United States, 35249
- University of Alabama at Birmingham Medical Center
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Texas
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Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
Administered IV
Administered IV
Other Names:
|
Experimental: 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. |
Administered IV
Other Names:
Administered IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Part A: Maximum Tolerated Dose of Prexasertib in Combination with Cisplatin and Radiation Therapy
Time Frame: First Dose through Last Dose (Estimated up to 7 Weeks)
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First Dose through Last Dose (Estimated up to 7 Weeks)
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Part B: Maximum Tolerated Dose of Prexasertib in Combination with Cetuximab and Radiation Therapy
Time Frame: First Dose through Last Dose (Estimated up to 8 Weeks)
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First Dose through Last Dose (Estimated up to 8 Weeks)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics (PK): Maximum Concentration of Prexasertib, Cisplatin and Cetuximab
Time Frame: First Dose through Last Dose (Estimated up to 8 Weeks)
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First Dose through Last Dose (Estimated up to 8 Weeks)
|
PK: Area Under the Concentration Curve (AUC) of Prexasertib
Time Frame: First Dose through Last Dose (Estimated up to 8 Weeks)
|
First Dose through Last Dose (Estimated up to 8 Weeks)
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Locoregional Control Rate
Time Frame: Baseline through One Year (Estimated as up to 52 Weeks) or Death from Any Cause
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Baseline through One Year (Estimated as up to 52 Weeks) or Death from Any Cause
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Zeng L, Nikolaev A, Xing C, Della Manna DL, Yang ES. CHK1/2 Inhibitor Prexasertib Suppresses NOTCH Signaling and Enhances Cytotoxicity of Cisplatin and Radiation in Head and Neck Squamous Cell Carcinoma. Mol Cancer Ther. 2020 Jun;19(6):1279-1288. doi: 10.1158/1535-7163.MCT-19-0946. Epub 2020 May 5.
- Zeng L, Beggs RR, Cooper TS, Weaver AN, Yang ES. Combining Chk1/2 Inhibition with Cetuximab and Radiation Enhances In Vitro and In Vivo Cytotoxicity in Head and Neck Squamous Cell Carcinoma. Mol Cancer Ther. 2017 Apr;16(4):591-600. doi: 10.1158/1535-7163.MCT-16-0352. Epub 2017 Jan 30.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16016 (REB)
- I4D-MC-JTJI (Other Identifier: Eli Lilly and Company)
- 2015-001215-12 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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