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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-22

Study Completion Date

2017-07-27

Brief Summary

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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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Detailed Description

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Conditions

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Advanced Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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[¹⁴C]Prexasertib

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

Group Type EXPERIMENTAL

[¹⁴C]Prexasertib

Intervention Type DRUG

Administered IV Infusion

Prexasertib

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)

Group Type EXPERIMENTAL

Prexasertib

Intervention Type DRUG

Administered IV Infusion

Interventions

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[¹⁴C]Prexasertib

Administered IV Infusion

Intervention Type DRUG

Prexasertib

Administered IV Infusion

Intervention Type DRUG

Other Intervention Names

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[¹⁴C]LY2606368 LY2606368

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No