Advanced CancerPhase 1NCT02778126
A Study of Prexasertib (LY2606368) in Participants With Advanced Cancer
A Phase 1 study testing [¹⁴C]Prexasertib and Prexasertib in people with Advanced Cancer, run by Eli Lilly and Company at 1 site in United Kingdom.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- [¹⁴C]Prexasertib and Prexasertib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Sep 2016to 27 Jul 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
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
About this study
Official title: Disposition of [¹⁴C]LY2606368 Following Intravenous Administration in Patients With Advanced and/or Metastatic Solid Tumours
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
- Being tested
- [¹⁴C]Prexasertib, Prexasertib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[¹⁴C]PrexasertibDrug
Also called [¹⁴C]LY2606368
Administered IV Infusion
PrexasertibDrug
Also called LY2606368
Administered IV Infusion
| Study group | Role | What they receive |
|---|---|---|
| [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. Receives: 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) Receives: Drug: Prexasertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Excretion of LY2606368 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Measured: 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
Measured: 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
Measured: Baseline through 120 hours after administration of study drug
Secondary outcomes (4)
Pharmacokinetics: Maximum Concentration (Cmax) of LY2606368 and Radioactivity
Measured: 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
Measured: 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
Measured: Predose through 120 hours after administration of study drug
Relative Abundance of LY2606368 As Measured by Percentage of Radioactivity in Feces and Urine
Measured: Baseline through 120 hours after administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study start22 Sep 2016
- Primary completion29 Apr 2017
- Study completion27 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778126
- Sponsor's protocol ID
- 15556
- Other IDs
- I4D-EW-JTJG, 2015-003126-13, 2015
- Status last verified
- Jul 2019
- First submitted
- 18 May 2016
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disposition of [¹⁴C]LY2606368 Following Intravenous Administration in Patients With Advanced and/or Metastatic Solid Tumours
- ClinicalTrials.gov ID
- NCT02778126
- Acronym / sponsor ID
- 15556
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2016
- Primary completion
- 29 Apr 2017 (actual)
- Study completion
- 27 Jul 2017 (actual)
- First posted
- 19 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| [¹⁴C]Prexasertib | Experimental | Drug: [¹⁴C]Prexasertib170 milligrams (mg) of prexasertib containing approximately 50 μCi [¹⁴C] prexasertib radiotracer administered intravenously (IV) as a 1 hour continuous IV infusion. |
| Prexasertib | Experimental | Drug: Prexasertib105 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [¹⁴C]PrexasertibAlso: [¹⁴C]LY2606368Administered IV Infusion | Drug | [¹⁴C]Prexasertib |
| PrexasertibAlso: LY2606368Administered IV Infusion | Drug | Prexasertib |
Primary outcome
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
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
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
4 secondary outcomes
Pharmacokinetics: Maximum Concentration (Cmax) of LY2606368 and Radioactivity
Time frame: 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
Time frame: 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
Time frame: Predose through 120 hours after administration of study drug
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- Click here for more information about this study: A Study of LY2606368 in Participants With Advanced CancerLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [¹⁴C]Prexasertib and Prexasertib in people with Advanced Cancer, run by Eli Lilly and Company at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2019.