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

NCT02778126 | Completed Phase 1

• 3 other identifiers: 15556I4D-EW-JTJG2015-003126-13
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• Pharmacokinetics: Maximum Concentration (Cmax) of LY2606368 and Radioactivity

  Predose through 120 hours after administration of study drug

• 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

• Pharmacokinetics: Area Under the Concentration Time Curve from Time Zero to Infinity (AUC0-∞) of LY2606368 and Radioactivity

  Predose through 120 hours after administration of study drug

• Relative Abundance of LY2606368 As Measured by Percentage of Radioactivity in Feces and Urine

  Baseline through 120 hours after administration of study drug

Study Arms (2)

[¹⁴C]Prexasertib

EXPERIMENTAL

170 milligrams (mg) of prexasertib containing approximately 50 μCi \[¹⁴C\] prexasertib radiotracer administered intravenously (IV) as a 1 hour continuous IV infusion.

Drug: [¹⁴C]Prexasertib

Prexasertib

EXPERIMENTAL

105 milligrams per square meter (mg/m²) of prexasertib administered IV as a 1 hour continuous IV infusion once every 14 days (14 day cycles). Treatment may continue until discontinuation criteria are met. Treatment for this arm was administered after ¹⁴C administration (¹⁴C was administered during first phase of the study)

Drug: Prexasertib

Interventions

[¹⁴C]Prexasertib DRUG

Administered IV Infusion

Also known as: [¹⁴C]LY2606368

[¹⁴C]Prexasertib

Prexasertib DRUG

Administered IV Infusion

Also known as: LY2606368

Prexasertib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, United Kingdom

Location

Related Links

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

MeSH Terms

Interventions

prexasertib

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 19, 2016
• Study Start: September 22, 2016
• Primary Completion: April 29, 2017
• Study Completion: July 27, 2017
• Last Updated: August 1, 2019

Record last verified: 2019-07

Locations

GB (1)