NCT02555644

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2016

Typical duration for phase_1

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

February 24, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

2.9 years

First QC Date

September 18, 2015

Last Update Submit

February 12, 2019

Conditions

Head and Neck Neoplasms

Keywords

cancer

Outcome Measures

Primary Outcomes (2)

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

    First Dose through Last Dose (Estimated up to 7 Weeks)

  • 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 Outcomes (3)

  • Pharmacokinetics (PK): Maximum Concentration of Prexasertib, Cisplatin and Cetuximab

    First Dose through Last Dose (Estimated up to 8 Weeks)

  • PK: Area Under the Concentration Curve (AUC) of Prexasertib

    First Dose through Last Dose (Estimated up to 8 Weeks)

  • Locoregional Control Rate

    Baseline through One Year (Estimated as up to 52 Weeks) or Death from Any Cause

Study Arms (2)

Prexasertib + Cisplatin + Radiation Therapy (Part A)

EXPERIMENTAL

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: PrexasertibDrug: CisplatinRadiation: Intensity Modulated Radiation Therapy

Prexasertib + Cetuximab + Radiation Therapy (Part B)

EXPERIMENTAL

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: PrexasertibDrug: CetuximabRadiation: Intensity Modulated Radiation Therapy

Interventions

PrexasertibDRUG

Administered IV

Also known as: LY2606368
Prexasertib + Cetuximab + Radiation Therapy (Part B)Prexasertib + Cisplatin + Radiation Therapy (Part A)
CisplatinDRUG

Administered IV

Prexasertib + Cisplatin + Radiation Therapy (Part A)
CetuximabDRUG

Administered IV

Also known as: Erbitux, LY2939777
Prexasertib + Cetuximab + Radiation Therapy (Part B)
Intensity Modulated Radiation TherapyRADIATION
Prexasertib + Cetuximab + Radiation Therapy (Part B)Prexasertib + Cisplatin + Radiation Therapy (Part A)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Alabama at Birmingham Medical Center

Birmingham, Alabama, 35249, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Centre Leon Berard

Lyon, 69008, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (2)

  • 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.

    PMID: 32371584DERIVED

  • 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.

    PMID: 28138028DERIVED

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsNeoplasms

Interventions

prexasertibCisplatinCetuximabRadiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsRadiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2015

First Posted

September 21, 2015

Study Start

February 24, 2016

Primary Completion

January 14, 2019

Study Completion

January 14, 2019

Last Updated

February 15, 2019

Record last verified: 2019-02-01

Locations

US(2)FR(2)