A Phase 1 Study in Participants With Advanced Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01115790
First received: April 28, 2010
Last updated: June 6, 2014
Last verified: June 2014

April 28, 2010
June 6, 2014
February 2010
May 2015   (final data collection date for primary outcome measure)
  • 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 ]
  • Determination of a recommended Phase 2 dosing regimen [ Time Frame: Time of first dose until last dose ] [ Designated as safety issue: Yes ]
  • Determination of clinically significant safety effects [ Time Frame: Time of first dose until last dose ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01115790 on ClinicalTrials.gov Archive Site
  • 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 LY2606368 (Cmax) (Parts A, B, and C) [ Time Frame: During Cycles 1 and 2 ] [ Designated as safety issue: No ]
  • Preliminary Pharmacokinetics of LY2606368 (AUC) (Parts A, B, and C) [ Time Frame: During Cycles 1 and 2 ] [ Designated as safety issue: No ]
  • Part A: document any antitumor activity [ Time Frame: During every cycle and initial follow-up visit ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Part B: Progression Free Survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Part A and B: Preliminary pharmacokinetics of LY2606368 (Cmax) [ Time Frame: During Cycles 1 and 2 ] [ Designated as safety issue: No ]
  • Part A and B: Preliminary pharmacokinetics of LY2606368 (AUC) [ Time Frame: During cycles 1 and 2 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Phase 1 Study in Participants With Advanced Cancer
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 LY2606368 (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 LY2606368 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.

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

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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: LY2606368
LY2606368 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.
Experimental: LY2606368
Intervention: Drug: LY2606368
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
May 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559
United States
 
NCT01115790
13129, I4D-MC-JTJA
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
June 2014

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