Trial · NCT00586508
Trial of Enzastaurin and Bevacizumab in Participants With Recurrent Malignant Gliomas
NCT00586508, Phase 2, Completed, Eli Lilly and Company; results first posted 2020-09-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial of Enzastaurin and Bevacizumab in Participants With Recurrent Malignant Gliomas. Trials, record NCT00586508. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00586508
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Enzastaurin and Bevacizumab in Participants With Recurrent Malignant Gliomas
- NCT number
- NCT00586508
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 81 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Recurrent Glioblastoma
- Interventions
- enzastaurin, bevacizumab, Enzyme-inducing antiepileptic drugs (EIAED), Non-enzyme inducing antiepileptic drugs (NEIAED)
- First posted
- 2008-01-04
- Last updated
- 2020-09-24
- Results first posted
- 2020-09-24
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival at 6 Months (PFS-6) | Registration to 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). |
| Primary | Time to Progressive Disease (PD) | Registration to PD, death or date of last contact up to 66.56 months | Defined as the time from registration to PD, death or date of last contact. 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). Participants who had no PD or death at the time of the data inclusion cutoff, time to PD was censored at their last tumor assessment prior to the cutoff date. |
| Primary | Number of Participants With Adverse Events (AEs) or Deaths (Safety) | Registration to study completion up to 67.56 months | Data presented are the number of participants who experienced serious adverse events (SAEs), other non-serious AEs and deaths during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module. |
| Secondary | Overall Response Rate (ORR) | Registration to date of objective PD or death up to 66.56 months | Overall response is confirmed complete response (CR) + partial response (PR). CR is complete disappearance of all measurable and evaluable disease, no new lesions, and no evidence of non-evaluable disease. PR is ≥50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions (or the 2 largest lesions), no progression of evaluable disease and no new lesions. ORR is calculated as (total number of participants with CR or PR from the start of registration until disease progression) / (the total number of participants treated)\*100. |
| Secondary | To Evaluate Tumor Markers and Genes | Baseline and every cycle (4-week cycles) | |
| Secondary | Change From Baseline in Health-Related Quality of Life (HRQoL) Subscales | Baseline, Cycles 1-12 (4-week cycles) | HRQoL was assessed with the Functional Assessment of Cancer Therapy - Brain (FACT-Br) version 4. The instrument consists of 50 items with a 5-point rating scale for each item, where 0 = "not at all" and 4 = "very much." Physical well-being, social/family well-being and functional well-being subscales consist of 7 items each with scores ranging from 0-28. The emotional well-being subscale consists of 6 items with a score ranging from 0-24. The brain cancer-specific subscale consists of 23 items with a score ranging from 0-92. Higher scores in each subscale represent better QoL. Changes from baseline in the 4 core subscales are presented. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival at 6 Months (PFS-6) | Registration to 6 months | All enrolled participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Time to Progressive Disease (PD) | Registration to PD, death or date of last contact up to 66.56 months | All enrolled participants who received at least 1 dose of study drug. The number of participants censored are 7 for Enzastaurin + Bevacizumab NEIAED) group and 0 for Enzastaurin + Bevacizumab (EIAED) group. | months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) | Registration to date of objective PD or death up to 66.56 months | All enrolled participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | To Evaluate Tumor Markers and Genes | Baseline and every cycle (4-week cycles) | Data were not collected for any participant due to low samples. | ||
| SECONDARY | Change From Baseline in Health-Related Quality of Life (HRQoL) Subscales | Baseline, Cycles 1-12 (4-week cycles) | All enrolled participants who received at least 1 dose of study drug and had HRQoL assessed at baseline and in the end of Cycles 1-12. | units on a scale | MEAN |
| PRIMARY | Number of Participants With Adverse Events (AEs) or Deaths (Safety) | Registration to study completion up to 67.56 months | All enrolled participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group92
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival at 6 Months (PFS-6) | Enzastaurin + Bevacizumab (NEIAED) | 31 | 95% Confidence Interval 21 to 42 | percentage of participants | |
| Progression-Free Survival at 6 Months (PFS-6) | Enzastaurin + Bevacizumab (EIAED) | 15 | 95% Confidence Interval 2 to 39 | percentage of participants | |
| Time to Progressive Disease (PD) | Enzastaurin + Bevacizumab (NEIAED) | 2.76 | 95% Confidence Interval 2.00 to 4.37 | months | |
| Time to Progressive Disease (PD) | Enzastaurin + Bevacizumab (EIAED) | 1.84 | 95% Confidence Interval 0.92 to 2.69 | months | |
| Overall Response Rate (ORR) | Enzastaurin + Bevacizumab (NEIAED) | 5.9 | 95% Confidence Interval 1.6 to 14.4 | percentage of participants | |
| Overall Response Rate (ORR) | Enzastaurin + Bevacizumab (EIAED) | 0 | 95% Confidence Interval NA to NA | percentage of participants | |
| Change From Baseline in Health-Related Quality of Life (HRQoL) Subscales | Enzastaurin + Bevacizumab (NEIAED) | Physical Well-Being Cycle 1 | 1.4 | Standard Deviation 3.27 | units on a scale |
| Change From Baseline in Health-Related Quality of Life (HRQoL) Subscales | Enzastaurin + Bevacizumab (EIAED) | Physical Well-Being Cycle 1 | 2.5 | Standard Deviation 4.04 | units on a scale |
| Change From Baseline in Health-Related Quality of Life (HRQoL) Subscales | Enzastaurin + Bevacizumab (NEIAED) | Physical Well-Being Cycle 2 | 1.2 | Standard Deviation 3.15 | units on a scale |
| Change From Baseline in Health-Related Quality of Life (HRQoL) Subscales | Enzastaurin + Bevacizumab (EIAED) | Physical Well-Being Cycle 2 | 2.0 | Standard Deviation 4.36 | units on a scale |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Enzastaurin + Bevacizumab (NEIAED) | 68 | |
| Overall Study | STARTED | Enzastaurin + Bevacizumab (EIAED) | 13 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Enzastaurin + Bevacizumab (NEIAED) | 68 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Enzastaurin + Bevacizumab (EIAED) | 13 | |
| Overall Study | COMPLETED | Enzastaurin + Bevacizumab (NEIAED) | 0 | |
| Overall Study | COMPLETED | Enzastaurin + Bevacizumab (EIAED) | 0 | |
| Overall Study | NOT COMPLETED | Enzastaurin + Bevacizumab (NEIAED) | 68 | |
| Overall Study | NOT COMPLETED | Enzastaurin + Bevacizumab (EIAED) | 13 |
Source ClinicalTrials.gov
Adverse events214
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Sinus tachycardia | Cardiac disorders | Enzastaurin + Bevacizumab (NEIAED) | 1 | 68 | 1 |
| other | Sinus tachycardia | Cardiac disorders | Enzastaurin + Bevacizumab (EIAED) | 1 | 13 | 1 |
| other | Cushingoid | Endocrine disorders | Enzastaurin + Bevacizumab (NEIAED) | 4 | 68 | 4 |
| other | Cushingoid | Endocrine disorders | Enzastaurin + Bevacizumab (EIAED) | 0 | 13 | 0 |
| other | Diplopia | Eye disorders | Enzastaurin + Bevacizumab (NEIAED) | 0 | 68 | 0 |
| other | Diplopia | Eye disorders | Enzastaurin + Bevacizumab (EIAED) | 1 | 13 | 1 |
| other | Vision blurred | Eye disorders | Enzastaurin + Bevacizumab (NEIAED) | 3 | 68 | 3 |
| other | Vision blurred | Eye disorders | Enzastaurin + Bevacizumab (EIAED) | 1 | 13 | 1 |
| other | Constipation | Gastrointestinal disorders | Enzastaurin + Bevacizumab (NEIAED) | 6 | 68 | 6 |
| other | Constipation | Gastrointestinal disorders | Enzastaurin + Bevacizumab (EIAED) | 3 | 13 | 3 |
1 to 10 of 214Source ClinicalTrials.gov
See all 214 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Enzastaurin + Bevacizumab (NEIAED) | ||
| Total, all-cause mortality | Enzastaurin + Bevacizumab (EIAED) | ||
| Total, other adverse events | Enzastaurin + Bevacizumab (NEIAED) | 68 | 68 |
| Total, other adverse events | Enzastaurin + Bevacizumab (EIAED) | 13 | 13 |
| Total, serious adverse events | Enzastaurin + Bevacizumab (NEIAED) | 24 | 68 |
| Total, serious adverse events | Enzastaurin + Bevacizumab (EIAED) | 4 | 13 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Enzastaurin + Bevacizumab (NEIAED) vs Enzastaurin + Bevacizumab (EIAED): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00586508
GET https://conductscience.org/api/trials/v1/NCT00586508/results?page=2