Clinical trial · Interventional
A Study of Prexasertib (LY2606368) in Participants With Advanced Cancer
Disposition of [¹⁴C]LY2606368 Following Intravenous Administration in Patients With Advanced and/or Metastatic Solid Tumours
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [¹⁴C]Prexasertib | Drug | Prexasertib | ALIAS |
| Prexasertib | Drug | Prexasertib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- [¹⁴C]Prexasertib
- description
- 170 milligrams (mg) of prexasertib containing approximately 50 μCi \[¹⁴C\] prexasertib radiotracer administered intravenously (IV) as a 1 hour continuous IV infusion.
- interventionNames
- Drug: [¹⁴C]Prexasertib
- type
- EXPERIMENTAL
- label
- Prexasertib
- 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)
- interventionNames
- Drug: Prexasertib
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available