A Phase 1 Study in Participants With Advanced Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
Part C added per protocol amendment (February, 2013).
Study Design
Arms and Interventions
| 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:
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Outcome Measures
Primary Outcome Measures
- 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)]
- Determination of Clinically Significant Safety Effects (Parts A and B) [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) [Baseline until disease progression or death from any cause (estimated as up to 24 weeks)]
Secondary Outcome Measures
- 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)]
- Progression Free Survival (Parts B and C) [Baseline to measured progressive disease (estimated up to 24 weeks)]
- 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)]
- Preliminary Pharmacokinetics of Prexasertib (Cmax) (Parts A, B, and C) [During Cycles 1 and 2]
- Preliminary Pharmacokinetics of Prexasertib (AUC) (Parts A, B, and C) [During Cycles 1 and 2]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Must be appropriate candidate for experimental therapy, as determined by investigator, after available standard therapies have failed
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Have adequate organ function
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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
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Part A: Must have diagnosis of cancer that is advanced or metastatic
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Part B: Must have histologically confirmed squamous cell cancer of the head and neck or must have squamous cell cancer of any tumor type
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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
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Must be available during the duration of the study and willing to follow the study procedures
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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
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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:
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Must not have taken an unapproved drug as treatment for any indication within the last 28 days prior to starting study treatment
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Must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C
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Must not have a serious heart condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last three months
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Must not have systolic blood pressure <90 millimeters of mercury (mmHg) or recurrent symptomatic orthostatic hypotension
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Must not have a family history of long QTc syndrome or be taking drugs known to cause QTc prolongation or Torsades de Pointes
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Must not have a serotonin-secreting carcinoid tumor or a prior history of drug-induced serotonin syndrome
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Must not have acute leukemia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Florida Cancer Specialists | Sarasota | Florida | United States | 34232 |
| 2 | Peggy and Charles Stephenson Oklahoma Cancer Center | Oklahoma City | Oklahoma | United States | 73104 |
| 3 | Sarah Cannon Research Institute SCRI | Nashville | Tennessee | United States | 37203 |
| 4 | Tennessee Oncology PLLC | Nashville | Tennessee | United States | 37203 |
| 5 | University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 13129
- I4D-MC-JTJA