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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01115790
Other study ID # 13129
Secondary ID I4D-MC-JTJA
Status Completed
Phase Phase 1
First received April 28, 2010
Last updated May 9, 2016
Start date February 2010
Est. completion date January 2016

Study information

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

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

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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