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

Lilly

Status and phase: Completed; Phase 1

Conditions: Advanced Cancer

Treatments: Drug: [¹⁴C]Prexasertib; Drug: Prexasertib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02778126

15556

I4D-EW-JTJG (Other Identifier)

2015-003126-13 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

[¹⁴C]Prexasertib

Experimental group

Description:

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

Treatment:

Drug: [¹⁴C]Prexasertib

Prexasertib

Experimental group

Description:

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)

Treatment:

Drug: Prexasertib