NeoplasmPhase 1NCT02514603
A Study of Prexasertib (LY2606368) in Japanese Participants With Advanced Cancers
A Phase 1 study testing Prexasertib in people with Neoplasm, run by Eli Lilly and Company at 2 sites in Japan.
Trial summary
The primary purpose of this study is to assess the tolerability of prexasertib in Japanese participants with advanced solid cancers. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Neoplasm
- What is being tested?
- Prexasertib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesJapan
- Study dates
- Oct 2015to 10 Apr 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be appropriate candidate for experimental therapy, as determined by investigator, after available standard therapies have failed
- Participant must have diagnosis of cancer that is advanced or metastatic
- Participant must have discontinued previous treatments for cancer and recovered from the acute effects of that therapy
- If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for three months following the last dose of study drug
- If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 7 days of the first dose of study drug and must not be breast feeding
Who cannot join
- Participant must not have symptomatic central nervous system malignancy or metastasis
- Participant must not have current hematologic malignancy
- Participant must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C
- Participant must not have a serious cardiac condition
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chiba, 277 8577
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tokyo, 104-0045
About this study
Official title: A Phase 1 Study of LY2606368 in Japanese Patients With Advanced Solid Tumors
The primary purpose of this study is to assess the tolerability of prexasertib in Japanese participants with advanced solid cancers.
- Conditions
- Neoplasm
- Being tested
- Prexasertib
- Keywords
- Neoplasm metastasis, Checkpoint Kinase 1, CHK1, CHK1 inhibitor
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrexasertibDrug
Also called LY2606368
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Prexasertib | Experimental | Prexasertib intravenously (IV) on day 1 of a 14 day cycle. Treatment with prexasertib may continue until disease progression, unacceptable toxicity, or other discontinuation criteria are met. Receives: Drug: Prexasertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Prexasertib Dose-Limiting Toxicities (DLT)
Measured: Cycle 1 (14 day cycle)
Secondary outcomes (3)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib
Measured: Pre-dose up to 7 Days Post Treatment in Cycle 1/2 (Approximately 7 Days)
Pharmacokinetics (PK): Area Under Curve (AUC) of Prexasertib
Measured: Pre-dose up to 7 Days Post Treatment in Cycle1/2 (Approximately 7 Days)
Percentage of Participants with a Tumor Response
Measured: Baseline to Study Completion (Approximately 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study startOct 2015
- Primary completion10 Apr 2017
- Study completion10 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT02514603
- Sponsor's protocol ID
- 16018
- Other IDs
- I4D-JE-JTJK
- Status last verified
- May 2017
- First submitted
- 31 Jul 2015
- Last updated
- 22 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of LY2606368 in Japanese Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02514603
- Acronym / sponsor ID
- 16018
- Conditions
- Neoplasm
- Keywords
- Neoplasm metastasis, Checkpoint Kinase 1, CHK1, CHK1 inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- 10 Apr 2017 (actual)
- Study completion
- 10 Apr 2017 (actual)
- First posted
- 3 Aug 2015 (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 primary purpose of this study is to assess the tolerability of prexasertib in Japanese participants with advanced solid cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prexasertib | Experimental | Drug: PrexasertibPrexasertib intravenously (IV) on day 1 of a 14 day cycle. Treatment with prexasertib may continue until disease progression, unacceptable toxicity, or other discontinuation criteria are met. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant must be appropriate candidate for experimental therapy, as determined by investigator, after available standard therapies have failed
- Participant must have diagnosis of cancer that is advanced or metastatic
- Participant must have discontinued previous treatments for cancer and recovered from the acute effects of that therapy
- If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for three months following the last dose of study drug
- If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 7 days of the first dose of study drug and must not be breast feeding
Key exclusion criteria (4 listed)
- Participant must not have symptomatic central nervous system malignancy or metastasis
- Participant must not have current hematologic malignancy
- Participant must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C
- Participant must not have a serious cardiac condition
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 |
|---|---|---|
| PrexasertibAlso: LY2606368Administered IV | Drug | Prexasertib |
Primary outcome
Number of Participants with Prexasertib Dose-Limiting Toxicities (DLT)
Time frame: Cycle 1 (14 day cycle)
3 secondary outcomes
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib
Time frame: Pre-dose up to 7 Days Post Treatment in Cycle 1/2 (Approximately 7 Days)
Pharmacokinetics (PK): Area Under Curve (AUC) of Prexasertib
Time frame: Pre-dose up to 7 Days Post Treatment in Cycle1/2 (Approximately 7 Days)
Percentage of Participants with a Tumor Response
Time frame: Baseline to Study Completion (Approximately 24 weeks)
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 22 May 2017.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Prexasertib in people with Neoplasm, run by Eli Lilly and Company at 2 sites in Japan.
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 5 inclusion and 4 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 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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?
Number of Participants with Prexasertib Dose-Limiting Toxicities (DLT) (time frame: Cycle 1 (14 day cycle)). 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 22 May 2017.