Ovarian CancerPhase 2NCT00420381
Evaluation of Enzastaurin in the Treatment of Persistent or Recurrent Ovarian or Primary Peritoneal Cancer
A Phase 2 study testing enzastaurin in people with Ovarian Cancer and Neoplasms, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The purpose is to assess the efficacy and toxicity of the study agent, enzastaurin, in participants with recurrent or persistent ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Neoplasms, Carcinoma
- 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
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2014
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have recurrent or persistent epithelial ovarian or primary peritoneal carcinoma.
- All participants must have measurable disease.
- Participants must have at least one "target lesion" to be used to assess response on this protocol.
- Participants must not be eligible for a higher priority GOG protocol, if one exists.
- Participants who have received one prior regimen must have a GOG Performance Status of 0, 1, or 2. Participants who have received two prior regimens must have a GOG Performance Status of 0 or 1.
- Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy is permitted.
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- Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least four weeks prior to registration.
- Participants must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound.
- Participants must NOT have received any non-cytotoxic therapy for management of recurrent or persistent disease.
- Participants of child-bearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after discontinuation of study treatment.
Who cannot join
- Participants with previous enzastaurin treatment.
- Participants who have received radiation to more than 25% of marrow-bearing areas
- Participants with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy.
- Participants who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- Participants who are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin (refer to Concomitant Medications for a discussion of enzyme inducing anti-epileptic drugs [EIAEDs]).
- Participants who are receiving concurrent administration of any other systemic anticancer therapy except for a biphosphonate if patient has bony metastases.
- Participants who have received prior therapy with non-cytotoxic agents (i.e. bevacizumab).
- Participants with serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gynecologic Oncology Group 215-854-0770
Philadelphia, Pennsylvania, 19103
About this study
Official title: A Phase II Evaluation of Enzastaurin in the Treatment of Persistent or Recurrent Ovarian or Primary Peritoneal Carcinoma
The purpose is to assess the efficacy and toxicity of the study agent, enzastaurin, in participants with recurrent or persistent ovarian cancer.
- Conditions
- Ovarian Cancer, Neoplasms, Carcinoma
- Being tested
- enzastaurin
- Keywords
- Recurrent Cancer
- Medical subject headings
- Ovarian Neoplasms, Neoplasms, Carcinoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enzastaurinDrug
Also called LY317615
1125 mg loading dose then 500 mg, oral, daily, until progressive disease
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: enzastaurin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival for at Least 6 Months (PFS-6)
Data presented are the percentage of participants without progressive disease (PD) or death from any cause 6 months after registration. PD was a 25% increase in the sum of products of all measurable lesions (or 2 largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Measured: Baseline through 6 months
Number of Participants With Adverse Events and Severe Adverse Events
Data presented are the number of participants who experienced 1 or more adverse events (AEs) (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.
Measured: Baseline through end of study (Up to 45 months)
Secondary outcomes (4)
Duration of Progression-Free Survival
PFS is defined as the rate of PFS from the date of diagnosis to the first date of objectively determined progressive disease (based on radiological assessment) or death from any cause. It is assumed that PFS follows an exponential distribution.
Measured: Baseline to disease progression (Up to 38 months)
Prognostic Factors: Platinum Sensitivity
Participants who had disease progression within 6 months of ending their last regimen of platinum therapy were considered platinum resistant. Participants who had disease progression between 6 and 12 months of ending their last platinum regimen were considered platinum sensitive. Participants who had disease progression beyond 12 months of ending their last platinum regimen were also considered platinum sensitive.
Measured: Baseline
Prognostic Factors: Performance Status
Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work.
Measured: Baseline
Overall Survival
Overall survival (OS) time is defined as the time from the date of diagnosis to the date of death from any cause. For participants who are still alive at the time of analysis, survival time will be censored at the last contact date.
Measured: Baseline through end of study (Up to 45 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionMay 2008
- Study completionDec 2014
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 Ovarian 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gynecologic Oncology Group
- Responsible party
- Sponsor
- Investigators
- Lydia Usha, Study director, Gynecologic Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420381
- Sponsor's protocol ID
- 10738
- Other IDs
- H6Q-MC-S025
- Status last verified
- Nov 2020
- First submitted
- 8 Jan 2007
- Last updated
- 19 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Evaluation of Enzastaurin in the Treatment of Persistent or Recurrent Ovarian or Primary Peritoneal Carcinoma
- ClinicalTrials.gov ID
- NCT00420381
- Acronym / sponsor ID
- 10738
- Conditions
- Ovarian Cancer, Neoplasms, Carcinoma
- Keywords
- Recurrent Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Gynecologic Oncology Group
- Study start
- Jan 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Jan 2007 (estimated)
- Results
- Posted 19 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to assess the efficacy and toxicity of the study agent, enzastaurin, in participants with recurrent or persistent ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: enzastaurin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants must have recurrent or persistent epithelial ovarian or primary peritoneal carcinoma.
- All participants must have measurable disease.
- Participants must have at least one "target lesion" to be used to assess response on this protocol.
- Participants must not be eligible for a higher priority GOG protocol, if one exists.
- Participants who have received one prior regimen must have a GOG Performance Status of 0, 1, or 2. Participants who have received two prior regimens must have a GOG Performance Status of 0 or 1.
Key exclusion criteria (8 listed)
- Participants with previous enzastaurin treatment.
- Participants who have received radiation to more than 25% of marrow-bearing areas
- Participants with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy.
- Participants who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- Participants who are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin (refer to Concomitant Medications for a discussion of enzyme inducing anti-epileptic drugs [EIAEDs]).
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: LY3176151125 mg loading dose then 500 mg, oral, daily, until progressive disease | Drug | A |
Primary outcome
Progression-free Survival for at Least 6 Months (PFS-6)
Time frame: Baseline through 6 months
Data presented are the percentage of participants without progressive disease (PD) or death from any cause 6 months after registration. PD was a 25% increase in the sum of products of all measurable lesions (or 2 largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Number of Participants With Adverse Events and Severe Adverse Events
Time frame: Baseline through end of study (Up to 45 months)
Data presented are the number of participants who experienced 1 or more adverse events (AEs) (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.
4 secondary outcomes
Duration of Progression-Free Survival
Time frame: Baseline to disease progression (Up to 38 months)
Prognostic Factors: Platinum Sensitivity
Time frame: Baseline
Prognostic Factors: Performance Status
Time frame: Baseline
Overall Survival
Time frame: Baseline through end of study (Up to 45 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 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.
Lydia Usha study director
Gynecologic Oncology Group
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 Ovarian Cancer and Neoplasms, 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 10 inclusion and 8 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 19 Dec 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 19 Dec 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?
Progression-free Survival for at Least 6 Months (PFS-6) (time frame: Baseline through 6 months). The study lists 2 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 19 Dec 2020.