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

Primary Purpose

Head and Neck Neoplasms

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Prexasertib
Cisplatin
Cetuximab
Intensity Modulated Radiation Therapy
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Alabama at Birmingham Medical Center
  • University of Texas MD Anderson Cancer Center
  • Centre Leon Berard
  • Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Prexasertib + Cisplatin + Radiation Therapy (Part A)

Prexasertib + Cetuximab + Radiation Therapy (Part B)

Arm 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.

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.

Outcomes

Primary Outcome Measures

Part A: Maximum Tolerated Dose of Prexasertib in Combination with Cisplatin and Radiation Therapy
Part B: Maximum Tolerated Dose of Prexasertib in Combination with Cetuximab and Radiation Therapy

Secondary Outcome Measures

Pharmacokinetics (PK): Maximum Concentration of Prexasertib, Cisplatin and Cetuximab
PK: Area Under the Concentration Curve (AUC) of Prexasertib
Locoregional Control Rate

Full Information

First Posted
September 18, 2015
Last Updated
February 12, 2019
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT02555644
Brief Title
A Study of Prexasertib (LY2606368) With Chemotherapy and Radiation in Participants With Head and Neck Cancer
Official Title
A Phase 1b Trial of LY2606368 in Combination With Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 1, 2019
Overall Recruitment Status
Completed
Study Start Date
February 24, 2016 (Actual)
Primary Completion Date
January 14, 2019 (Actual)
Study Completion Date
January 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms
Keywords
cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prexasertib + Cisplatin + Radiation Therapy (Part A)
Arm Type
Experimental
Arm 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.
Arm Title
Prexasertib + Cetuximab + Radiation Therapy (Part B)
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Prexasertib
Other Intervention Name(s)
LY2606368
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
Erbitux, LY2939777
Intervention Description
Administered IV
Intervention Type
Radiation
Intervention Name(s)
Intensity Modulated Radiation Therapy
Primary Outcome Measure Information:
Title
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)
Title
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)
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Maximum Concentration of Prexasertib, Cisplatin and Cetuximab
Time Frame
First Dose through Last Dose (Estimated up to 8 Weeks)
Title
PK: Area Under the Concentration Curve (AUC) of Prexasertib
Time Frame
First Dose through Last Dose (Estimated up to 8 Weeks)
Title
Locoregional Control Rate
Time Frame
Baseline through One Year (Estimated as up to 52 Weeks) or Death from Any Cause

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Gustave Roussy
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32371584
Citation
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.
Results Reference
derived
PubMed Identifier
28138028
Citation
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.
Results Reference
derived

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

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