A Phase 1 Study in Participants With Advanced Cancer

May 9, 2016 updated by: Eli Lilly and Company

A Phase 1 Study of LY2606368 in Patients With Advanced Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • LY2606368

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time of first dose until last dose (estimated as up to 156 weeks)
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)
Time of first dose until last dose (estimated as up to 156 weeks)
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)
Baseline until disease progression or death from any cause (estimated as up to 24 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Baseline until disease progression or death from any cause (estimated as up to 24 weeks)
Progression Free Survival (Parts B and C)
Time Frame: Baseline to measured progressive disease (estimated up to 24 weeks)
Baseline to measured progressive disease (estimated up to 24 weeks)
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)
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)
Preliminary Pharmacokinetics of Prexasertib (Cmax) (Parts A, B, and C)
Time Frame: During Cycles 1 and 2
During Cycles 1 and 2
Preliminary Pharmacokinetics of Prexasertib (AUC) (Parts A, B, and C)
Time Frame: During Cycles 1 and 2
During Cycles 1 and 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

April 28, 2010

First Submitted That Met QC Criteria

May 3, 2010

First Posted (Estimate)

May 4, 2010

Study Record Updates

Last Update Posted (Estimate)

May 10, 2016

Last Update Submitted That Met QC Criteria

May 9, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13129
  • I4D-MC-JTJA (Other Identifier: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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