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A Phase 1 Study in Participants With Advanced Cancer

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ClinicalTrials.gov Identifier: NCT01115790
Recruitment Status : Completed
First Posted : May 4, 2010
Last Update Posted : May 10, 2016
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE April 28, 2010
First Posted Date  ICMJE May 4, 2010
Last Update Posted Date May 10, 2016
Study Start Date  ICMJE February 2010
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2013)
  • 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) ]
  • 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) ]
  • 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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2010)
  • Determination of a recommended Phase 2 dosing regimen [ Time Frame: Time of first dose until last dose ]
  • Determination of clinically significant safety effects [ Time Frame: Time of first dose until last dose ]
Change History Complete list of historical versions of study NCT01115790 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2016)
  • 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) ]
  • Progression Free Survival (Parts B and C) [ Time Frame: 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) ]
  • Preliminary Pharmacokinetics of Prexasertib (Cmax) (Parts A, B, and C) [ Time Frame: During Cycles 1 and 2 ]
  • Preliminary Pharmacokinetics of Prexasertib (AUC) (Parts A, B, and C) [ Time Frame: During Cycles 1 and 2 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2010)
  • Part A: document any antitumor activity [ Time Frame: During every cycle and initial follow-up visit ]
  • Part B: Clinical benefit rate by number of complete response (CR), partial response (PR) and stable disease (SD) [ Time Frame: 6 weeks after initiation of treatment and every 6 weeks following until patient discontinues ]
  • Part B: Progression Free Survival [ Time Frame: baseline to measured progressive disease ]
  • Part B: Duration of response [ Time Frame: First observation of complete response (CR) or partial response (PR) to first observation of progressive disease or death ]
  • Part A and B: Preliminary pharmacokinetics of LY2606368 (Cmax) [ Time Frame: During Cycles 1 and 2 ]
  • Part A and B: Preliminary pharmacokinetics of LY2606368 (AUC) [ Time Frame: During Cycles 1 and 2 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Study in Participants With Advanced Cancer
Official Title  ICMJE A Phase 1 Study of LY2606368 in Patients With Advanced Cancer
Brief Summary 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.
Detailed Description Part C added per protocol amendment (February, 2013).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Prexasertib
Intervention: Drug: Prexasertib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2013)
150
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2010)
70
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01115790
Other Study ID Numbers  ICMJE 13129
I4D-MC-JTJA ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP