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

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ClinicalTrials.gov Identifier: NCT02555644
Recruitment Status : Recruiting
First Posted : September 21, 2015
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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
Head and Neck Neoplasms Drug: Prexasertib Drug: Cisplatin Drug: Cetuximab Radiation: Intensity Modulated Radiation Therapy 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 Type : Interventional  (Clinical Trial)
Estimated 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 : February 24, 2016
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

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 Name: 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 Name: LY2606368

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

Radiation: Intensity Modulated Radiation Therapy



Primary Outcome Measures :
  1. 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) ]
  2. 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 Measures :
  1. Pharmacokinetics (PK): Maximum Concentration of Prexasertib, Cisplatin and Cetuximab [ Time Frame: First Dose through Last Dose (Estimated up to 8 Weeks) ]
  2. PK: Area Under the Concentration Curve (AUC) of Prexasertib [ Time Frame: First Dose through Last Dose (Estimated up to 8 Weeks) ]
  3. Locoregional Control Rate [ Time Frame: Baseline through One Year (Estimated as up to 52 Weeks) or Death from Any Cause ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02555644


Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

Locations
United States, Alabama
University of Alabama at Birmingham Medical Center Recruiting
Birmingham, Alabama, United States, 35249
Contact    205-934-2762      
Principal Investigator: Eddy Yang         
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact    713-792-6363      
Principal Investigator: Mehmet Altan         
France
Centre Leon Berard Recruiting
Lyon, France, 69008
Contact    33478785103      
Principal Investigator: Jérôme Fayette         
Gustave Roussy Recruiting
Villejuif Cedex, France, 94805
Contact    33142114931      
Principal Investigator: Eric Deutsch         
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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02555644     History of Changes
Other Study ID Numbers: 16016
I4D-MC-JTJI ( Other Identifier: Eli Lilly and Company )
2015-001215-12 ( EudraCT Number )
First Posted: September 21, 2015    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 1, 2018

Keywords provided by Eli Lilly and Company:
cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cisplatin
Cetuximab
Antineoplastic Agents