A Study of Prexasertib (LY2606368) in Participants With Advanced Cancer

Advanced Cancer Clinical Trial

Official title:

Disposition of [¹⁴C]LY2606368 Following Intravenous Administration in Patients With Advanced and/or Metastatic Solid Tumours

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02778126
• Other study ID #: 15556
• Secondary ID: I4D-EW-JTJG2015-
• Status: Completed
• Phase: Phase 1
• Start date: September 22, 2016
• Est. completion date: July 27, 2017

Study information

• Verified date: July 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 27, 2017
• Est. primary completion date: April 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Drug:
• [¹4C]Prexasertib
Administered IV Infusion
• Prexasertib
Administered IV Infusion

Locations

Country	Name	City	State
United Kingdom	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.	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Excretion of LY2606368 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered		Baseline through 120 hours after administration of study drug
Primary	Fecal Excretion of LY2606368 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered		Baseline through 120 hours after administration of study drug
Primary	LY2606368 Radioactivity in Expired Air Over Time Expressed as a Percentage of the Total Radioactive Dose Administered		Baseline through 120 hours after administration of study drug
Secondary	Pharmacokinetics: Maximum Concentration (Cmax) of LY2606368 and Radioactivity		Predose through 120 hours after administration of study drug
Secondary	Pharmacokinetics: Area Under the Concentration Time Curve from Time Zero to the Last Measured Concentration (AUC0-tlast) of LY2606368 and Radioactivity		Predose through 120 hours after administration of study drug
Secondary	Pharmacokinetics: Area Under the Concentration Time Curve from Time Zero to Infinity (AUC0-8) of LY2606368 and Radioactivity		Predose through 120 hours after administration of study drug
Secondary	Relative Abundance of LY2606368 As Measured by Percentage of Radioactivity in Feces and Urine		Baseline through 120 hours after administration of study drug

External Links

•   Click here for more information about this study: A Study of LY2606368 in Participants With Advanced Cancer