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Completed

NCT Number: NCT02778126

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

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.

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Key information

Conditions

Advanced Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[¹⁴C]Prexasertib

Drug

Administered IV Infusion

Other names: [¹⁴C]LY2606368

Prexasertib

Drug

Administered IV Infusion

Other names: LY2606368

Primary outcomes

  1. Urinary Excretion of LY2606368 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

    Time frame: Baseline through 120 hours after administration of study drug

  2. Fecal Excretion of LY2606368 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

    Time frame: Baseline through 120 hours after administration of study drug

  3. LY2606368 Radioactivity in Expired Air Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

    Time frame: Baseline through 120 hours after administration of study drug

Secondary outcomes

  1. Pharmacokinetics: Maximum Concentration (Cmax) of LY2606368 and Radioactivity

    Time frame: Predose through 120 hours after administration of study drug

  2. Pharmacokinetics: Area Under the Concentration Time Curve from Time Zero to the Last Measured Concentration (AUC0-tlast) of LY2606368 and Radioactivity

    Time frame: Predose through 120 hours after administration of study drug

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

    Time frame: Predose through 120 hours after administration of study drug

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

    Time frame: Baseline through 120 hours after administration of study drug

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 19, 2016
Registry last updated
Aug 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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