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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02555644
Collaborator
(none)
70
Enrollment
4
Locations
2
Arms
34.7
Actual Duration (Months)
17.5
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1b Trial of LY2606368 in Combination With Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Cancer
Actual Study Start Date :
Feb 24, 2016
Actual Primary Completion Date :
Jan 14, 2019
Actual Study Completion Date :
Jan 14, 2019

Arms and Interventions

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.

Drug: Prexasertib
Administered IV
Other Names:
  • LY2606368

    • Drug: Cisplatin
    Administered IV

    Radiation: Intensity Modulated Radiation Therapy
    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.

    Drug: Prexasertib
    Administered IV
    Other Names:
  • LY2606368

    • Drug: Cetuximab
    Administered IV
    Other Names:
  • Erbitux
  • LY2939777

    • Radiation: Intensity Modulated Radiation Therapy

    Outcome Measures

    Primary Outcome Measures

    1. Part A: Maximum Tolerated Dose of Prexasertib in Combination with Cisplatin and Radiation Therapy [First Dose through Last Dose (Estimated up to 7 Weeks)]

    2. 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 Outcome Measures

    1. Pharmacokinetics (PK): Maximum Concentration of Prexasertib, Cisplatin and Cetuximab [First Dose through Last Dose (Estimated up to 8 Weeks)]

    2. PK: Area Under the Concentration Curve (AUC) of Prexasertib [First Dose through Last Dose (Estimated up to 8 Weeks)]

    3. Locoregional Control Rate [Baseline through One Year (Estimated as up to 52 Weeks) or Death from Any Cause]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Medical Center Birmingham Alabama United States 35249
    2 University of Texas MD Anderson Cancer Center Houston Texas United States 77030
    3 Centre Leon Berard Lyon France 69008
    4 Gustave Roussy Villejuif Cedex France 94805

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: 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), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT02555644
    Other Study ID Numbers:
    • 16016
    • I4D-MC-JTJI
    • 2015-001215-12
    First Posted:
    Sep 21, 2015
    Last Update Posted:
    Feb 15, 2019
    Last Verified:
    Feb 1, 2019
    Keywords provided by Eli Lilly and Company
    cancer
    Additional relevant MeSH terms:
    Head and Neck Neoplasms
    Cetuximab

    Study Results

    No Results Posted as of Feb 15, 2019