Clinical trial NCT02778126: A Study of Prexasertib (LY2606368) in Participants With Advanced Cancer
Official title: Disposition of [¹⁴C]LY2606368 Following Intravenous Administration in Patients With Advanced and/or Metastatic Solid Tumours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-05-19
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the safety of the study drug known as Prexasertib (LY2606368) in participants with advanced cancer or cancer that has spread to other parts of the body. This study will involve a single dose of ¹⁴C radiolabelled Prexasertib . This means that a radioactive substance, carbon 14, will be incorporated into the study drug. This will provide information about the study drug and its breakdown products and will help determine how much passes from the blood into urine, feces and expired air. After a minimum 14-day washout period following the \[¹⁴C\] Prexasertib dose, participants will be allowed to receive continued access to Prexasertib as outpatients.


Eligibility criteria: Inclusion Criteria:

* Have a histological or cytological diagnosis of cancer (solid tumour), with clinical or radiologic evidence of locally advanced and/or metastatic disease, for which no life-prolonging therapy exists
* Have the presence of measurable and/or nonmeasurable disease as defined by the Response Evaluation Criteria In Solid Tumours
* Have Body Surface Area (BSA) greater than or equal to (≥)1.62 meter squared (m²) and less than or equal to (≤) 1.90 m²
* Have adequate organ function
* Have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale
* Have an estimated life expectancy, in the judgment of the investigator, that will permit the participant to complete 1 full cycle of treatment (beyond the initial \[¹⁴C\]prexasertib dose)

Exclusion Criteria:

* Have received treatment within 28 days of the initial dose of study drug with an investigational product or non-approved use of a drug or device
* Have serious pre-existing medical conditions (left to the discretion of the investigator)
* Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required)
* Have current haematologic malignancies or acute or chronic leukaemia
* Have an active fungal, bacterial, and/or known viral infection
* Have participated in a ¹⁴C (carbon) study within the last 6 months prior to screening for this study
* Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results

Primary outcomes:
measure: Urinary Excretion of LY2606368 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
timeFrame: Baseline through 120 hours after administration of study drug
measure: Fecal Excretion of LY2606368 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
timeFrame: Baseline through 120 hours after administration of study drug
measure: LY2606368 Radioactivity in Expired Air Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
timeFrame: Baseline through 120 hours after administration of study drug
Secondary outcomes:
measure: Pharmacokinetics: Maximum Concentration (Cmax) of LY2606368 and Radioactivity
timeFrame: Predose through 120 hours after administration of study drug
measure: Pharmacokinetics: Area Under the Concentration Time Curve from Time Zero to the Last Measured Concentration (AUC0-tlast) of LY2606368 and Radioactivity
timeFrame: Predose through 120 hours after administration of study drug
measure: Pharmacokinetics: Area Under the Concentration Time Curve from Time Zero to Infinity (AUC0-∞) of LY2606368 and Radioactivity
timeFrame: Predose through 120 hours after administration of study drug
measure: Relative Abundance of LY2606368 As Measured by Percentage of Radioactivity in Feces and Urine
timeFrame: Baseline through 120 hours after administration of study drug
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: