Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
A Phase 1 Study of LY2606368 in Patients With Advanced Cancer
Verified date | May 2016 |
Source | Eli Lilly and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | January 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
United States | Sarah Cannon Research Institute SCRI | Nashville | Tennessee |
United States | Tennessee Oncology PLLC | Nashville | Tennessee |
United States | Peggy and Charles Stephenson Oklahoma Cancer Center | Oklahoma City | Oklahoma |
United States | Florida Cancer Specialists | Sarasota | Florida |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determination of a Recommended Phase 2 Dosing Regimen: Maximum Tolerated Dose (Parts A and B) | Time of first dose until last dose (estimated as up to 156 weeks) | Yes | |
Primary | Determination of Clinically Significant Safety Effects (Parts A and B) | Time of first dose until last dose (estimated as up to 156 weeks) | No | |
Primary | Percentage of Participants With a Complete or Partial Response (Overall Response Rate) (Part C) | Baseline until disease progression or death from any cause (estimated as up to 24 weeks) | No | |
Secondary | Percentage of Participants with Complete Response, Partial Response, or Stable Disease (Disease Control Rate) (Parts A, B, and C) | Baseline until disease progression or death from any cause (estimated as up to 24 weeks) | No | |
Secondary | Progression Free Survival (Parts B and C) | Baseline to measured progressive disease (estimated up to 24 weeks) | No | |
Secondary | Duration of Response (Parts B and C) | 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) | No | |
Secondary | Preliminary Pharmacokinetics of Prexasertib (Cmax) (Parts A, B, and C) | During Cycles 1 and 2 | No | |
Secondary | Preliminary Pharmacokinetics of Prexasertib (AUC) (Parts A, B, and C) | During Cycles 1 and 2 | No |
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