A Phase 1 Study in Participants With Advanced Cancer

This study has been completed.
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
First received: April 28, 2010
Last updated: May 9, 2016
Last verified: May 2016
The primary purpose of Parts A and B of this study is to evaluate the safety and toxicity of prexasertib (an inhibitor of checkpoint kinase 1[chk 1]) in participants with advanced or metastatic cancer (Part A), or squamous cell cancer of the head and neck or squamous cell cancer of any tumor type (Part B). Part C of the study will evaluate prexasertib in three different groups of participants; those with squamous cell cancer of the head and neck that has recurred or spread to other parts of the body, those with squamous non-small cell lung cancer that has recurred or spread, and those with squamous cell cancer of the anus that is not curable by existing therapy.

Condition Intervention Phase
Advanced Cancer
Squamous Cell Carcinoma
Carcinoma, Squamous Cell of Head and Neck
Lung Squamous Cell Carcinoma Stage IV
Anal Squamous Cell Carcinoma
Carcinoma, Non-Small-Cell Lung
Drug: Prexasertib
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of LY2606368 in Patients With Advanced Cancer

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Determination of a Recommended Phase 2 Dosing Regimen: Maximum Tolerated Dose (Parts A and B) [ Time Frame: Time of first dose until last dose (estimated as up to 156 weeks) ] [ Designated as safety issue: Yes ]
  • Determination of Clinically Significant Safety Effects (Parts A and B) [ Time Frame: Time of first dose until last dose (estimated as up to 156 weeks) ] [ Designated as safety issue: No ]
  • Percentage of Participants With a Complete or Partial Response (Overall Response Rate) (Part C) [ Time Frame: Baseline until disease progression or death from any cause (estimated as up to 24 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants with Complete Response, Partial Response, or Stable Disease (Disease Control Rate) (Parts A, B, and C) [ Time Frame: Baseline until disease progression or death from any cause (estimated as up to 24 weeks) ] [ Designated as safety issue: No ]
  • Progression Free Survival (Parts B and C) [ Time Frame: Baseline to measured progressive disease (estimated up to 24 weeks) ] [ Designated as safety issue: No ]
  • Duration of Response (Parts B and C) [ Time Frame: First observation of complete response (CR), partial response (PR), or stable disease (SD) to first observation of progressive disease or death (estimated up to 24 weeks) ] [ Designated as safety issue: No ]
  • Preliminary Pharmacokinetics of Prexasertib (Cmax) (Parts A, B, and C) [ Time Frame: During Cycles 1 and 2 ] [ Designated as safety issue: No ]
  • Preliminary Pharmacokinetics of Prexasertib (AUC) (Parts A, B, and C) [ Time Frame: During Cycles 1 and 2 ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: February 2010
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prexasertib Drug: Prexasertib
Prexasertib IV on day 1 of a 14 day cycle. The expected duration is 3 cycles (2 weeks each for a total of 6 weeks). Participants receiving clinical benefit may remain on study until disease progression, unacceptable toxicity or other criteria for discontinuation are met.
Other Name: LY2606368

Detailed Description:
Part C added per protocol amendment (February, 2013).

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must be appropriate candidate for experimental therapy, as determined by investigator, after available standard therapies have failed
  • Have adequate organ function
  • Prior Therapies: Systemic treatments: must have discontinued previous systemic treatments for cancer and recovered from the acute effects of therapy. Participants must have discontinued mitomycin-C or nitrosourea therapy at least 42 days and have discontinued any cytotoxic therapies at least 28 days prior to study enrollment. Radiation therapy and surgery: must be completed at least 4 weeks before study enrollment
  • Part A: Must have diagnosis of cancer that is advanced or metastatic
  • Part B: Must have histologically confirmed squamous cell cancer of the head and neck or must have squamous cell cancer of any tumor type
  • Part C: Must have histological diagnosis of squamous cell cancer of the head and neck, histological or cytological diagnosis of squamous non-small-cell lung cancer, or histological diagnosis of Stage IIIB (N2 or N3) or Stage IV squamous cell cancer of the anus that is not curable by local therapy
  • Must be available during the duration of the study and willing to follow the study procedures
  • If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for three 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 7 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 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 systolic blood pressure <90 millimeters of mercury (mmHg) or recurrent symptomatic orthostatic hypotension
  • Must not have a family history of long QTc syndrome or be taking drugs known to cause QTc prolongation or Torsades de Pointes
  • Must not have a serotonin-secreting carcinoid tumor or a prior history of drug-induced serotonin syndrome
  • Must not have acute leukemia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115790

United States, Florida
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
United States, Oklahoma
Peggy and Charles Stephenson Oklahoma Cancer Center
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, United States, 37203
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Eli Lilly and Company
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
  More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01115790     History of Changes
Other Study ID Numbers: 13129  I4D-MC-JTJA 
Study First Received: April 28, 2010
Last Updated: May 9, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anus Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Anus Diseases
Bronchial Neoplasms
Carcinoma, Bronchogenic
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Lung Diseases
Lung Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Rectal Diseases
Rectal Neoplasms
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on May 26, 2016