NeoplasmsPhase 2NCT00309140
An Open Label Study of Oral Enzastaurin in Participants With Cancer
A Phase 2 study testing enzastaurin in people with Neoplasms and Cancer, run by Eli Lilly and Company at 1 site in United States.
Trial summary
This study will collect further basic safety data on participants with cancer treated with enzastaurin. This study is not open to the public. The purpose of the this study is to extend the clinical experience of participants who complete enzastaurin therapy per clinical pharmacology and biopharmaceutics studies… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- enzastaurin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jul 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- You must have previously participated in and finished Study H6Q-LC-JCAV (JCAV), Study H6Q-LC-JCAY (JCAY), or other enzastaurin clinical pharmacology and biopharmaceutics studies. If you have had any other cancer treatment (chemotherapy, radiation, anti-cancer hormone therapy), you must have completed it at least 4 weeks ago before you can enroll in this study.
- You must have a cancer for which no other therapy exists that can prolong your life. This may include participants with treated, stable brain cancer.
- You must have lesions (areas of cancer in your body) that your doctor can either measure or detect.
- You either must not be able to become pregnant, (because you've had surgery ["tubes tied" or hysterectomy], you've gone through menopause, or you've had previous radiation for cancer that made you sterile) or your potential to become pregnant must be reduced by the use of an approved birth control method (including intrauterine or barrier devices) during and for 3 to 6 months following the study.
- You can be either male or female, and must be at least 18 years old.
Who cannot join
- You must not have received treatment within the last 30 days with a drug other than enzastaurin that is still experimental (this means it has not received approval to be prescribed, except in a clinical trial).
- You must not be pregnant or breastfeeding.
- You must not have central nervous system (CNS) tumors (tumors in your brain and spinal cord). (However, participants who have stable CNS tumors and are taking steroid medication may be included.)
- You must not have another serious disorder, including active infections that will interfere with your participation in the study.
- You must not have a second cancer in addition to your primary cancer. Participants with adequately treated skin cancer or who have had another cancer in the past, but have been cancer free for more than 2 years, are eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
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.
Sun City, Arizona, 85351
About this study
Official title: An Open-Label Study of Oral Enzastaurin HCl in Patients With Advanced or Metastatic Malignancies
This study will collect further basic safety data on participants with cancer treated with enzastaurin. This study is not open to the public.
The purpose of the this study is to extend the clinical experience of participants who complete enzastaurin therapy per clinical pharmacology and biopharmaceutics studies conducted by Eli Lilly and Company and who may benefit from continued enzastaurin therapy.
- Being tested
- enzastaurin
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enzastaurinDrug
Also called LY317615
500 milligrams (mg), oral, daily, six 42-day cycle and subsequent cycles or until participants met study discontinuation criteria of progressive disease or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Enzastaurin | Experimental | Not described Receives: Drug: enzastaurin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs
Data presented are the number of participants who experienced 1 or more AEs or any serious AEs (SAEs) regardless of causality. A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events section of this report.
Measured: Baseline through study completion (up to 26 months and 30-day safety follow-up)
Secondary outcomes (2)
Time to Disease Progression (Time to Documented Tumor Activity)
Time to disease progression was defined as the time in months from study enrollment to the first date of progressive disease. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease was defined as having at least a 20% increase in sum of the longest diameter of target lesions. Time to disease progression was censored at the date of the last follow-up for participants who did not experience progressive disease, death, or their disease status was unknown.
Measured: Baseline through study completion (up to 26 months and 30-day safety follow-up)
Percentage of Participants With Best Overall Response (Documented Antitumor Activity)
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Complete Response was defined as the disappearance of all target lesions. Partial Response was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Progressive Disease was defined as having at least a 20% increase in sum of longest diameter of target lesions. Stable Disease was defined as small changes that did not meet the above criteria. Also, reported were unknown and missing responses. Percentage of participants was calculated as the total number of participants affected divided by the number of participants analyzed then multiplied by 100.
Measured: Baseline through study completion (up to 26 months and 30-day safety follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 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
- NCT00309140
- Sponsor's protocol ID
- 10287
- Other IDs
- H6Q-MC-S001
- Status last verified
- Jun 2020
- First submitted
- 29 Mar 2006
- Last updated
- 26 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of Oral Enzastaurin HCl in Patients With Advanced or Metastatic Malignancies
- ClinicalTrials.gov ID
- NCT00309140
- Acronym / sponsor ID
- 10287
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 31 Mar 2006 (estimated)
- Results
- Posted 26 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will collect further basic safety data on participants with cancer treated with enzastaurin. This study is not open to the public.
The purpose of the this study is to extend the clinical experience of participants who complete enzastaurin therapy per clinical pharmacology and biopharmaceutics studies conducted by Eli Lilly and Company and who may benefit from continued enzastaurin therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enzastaurin | Experimental | Drug: enzastaurin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- You must have previously participated in and finished Study H6Q-LC-JCAV (JCAV), Study H6Q-LC-JCAY (JCAY), or other enzastaurin clinical pharmacology and biopharmaceutics studies. If you have had any other cancer treatment (chemotherapy, radiation, anti-cancer hormone therapy), you must have completed it at least 4 weeks ago before you can enroll in this study.
- You must have a cancer for which no other therapy exists that can prolong your life. This may include participants with treated, stable brain cancer.
- You must have lesions (areas of cancer in your body) that your doctor can either measure or detect.
- You either must not be able to become pregnant, (because you've had surgery ["tubes tied" or hysterectomy], you've gone through menopause, or you've had previous radiation for cancer that made you sterile) or your potential to become pregnant must be reduced by the use of an approved birth control method (including intrauterine or barrier devices) during and for 3 to 6 months following the study.
- You can be either male or female, and must be at least 18 years old.
Key exclusion criteria (5 listed)
- You must not have received treatment within the last 30 days with a drug other than enzastaurin that is still experimental (this means it has not received approval to be prescribed, except in a clinical trial).
- You must not be pregnant or breastfeeding.
- You must not have central nervous system (CNS) tumors (tumors in your brain and spinal cord). (However, participants who have stable CNS tumors and are taking steroid medication may be included.)
- You must not have another serious disorder, including active infections that will interfere with your participation in the study.
- You must not have a second cancer in addition to your primary cancer. Participants with adequately treated skin cancer or who have had another cancer in the past, but have been cancer free for more than 2 years, are eligible.
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 |
|---|---|---|
| enzastaurinAlso: LY317615500 milligrams (mg), oral, daily, six 42-day cycle and subsequent cycles or until participants met study discontinuation criteria of progressive disease or unacceptable toxicity | Drug | Enzastaurin |
Primary outcome
Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs
Time frame: Baseline through study completion (up to 26 months and 30-day safety follow-up)
Data presented are the number of participants who experienced 1 or more AEs or any serious AEs (SAEs) regardless of causality. A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events section of this report.
2 secondary outcomes
Time to Disease Progression (Time to Documented Tumor Activity)
Time frame: Baseline through study completion (up to 26 months and 30-day safety follow-up)
Percentage of Participants With Best Overall Response (Documented Antitumor Activity)
Time frame: Baseline through study completion (up to 26 months and 30-day safety follow-up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Lilly Clinical Trial RegistryLink 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 2 study testing enzastaurin in people with Neoplasms and Cancer, run by Eli Lilly and Company at 1 site in United States.
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 5 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 26 Jun 2020. 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 States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 1 or More Adverse Events (AEs) or Any Serious AEs (time frame: Baseline through study completion (up to 26 months and 30-day safety follow-up)). 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 26 Jun 2020.