Trial · NCT00402116
Phase 1/2 Study of Enzastaurin in Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma (GS) Patients
NCT00402116, Phase 1, Phase 2, Completed, Eli Lilly and Company; results first posted 2020-08-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 1/2 Study of Enzastaurin in Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma (GS) Patients. Trials, record NCT00402116. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00402116
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 1/2 Study of Enzastaurin in Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma (GS) Patients
- NCT number
- NCT00402116
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 72 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Glioblastoma, Glioblastoma Multiforme, Gliosarcoma
- Interventions
- enzastaurin, temozolomide, radiation therapy
- First posted
- 2006-11-22
- Last updated
- 2020-08-06
- Results first posted
- 2020-08-06
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1- Determination of the Maximum Tolerated Dose (MTD) of Enzastaurin | Until MTD can be determined (up to 12 cycles, 28 days per cycle) | Phase 1- dose escalation of enzastaurin in 2 cohorts up to 6 participants each in order to assess MTD. After radiation/enzastaurin 250 mg per day/temozolomide 75 mg/m\^2 therapy, if no more than 1 of 6 patients experienced a dose-limiting toxicity (DLT) or tumor progression, participants completed one 28-day cycle. If no significant toxicity after the first cycle, participants received subsequent cycles. If no more than 1 of the 6 patients treated at 250 mg of enzastaurin experienced a DLT, up to 6 more patients could be entered at escalated dose cohort of enzastaurin (500 mg). |
| Primary | Phase 1 and Phase 2 - Overall Survival (OS) | Baseline to death from any cause (Up to 48 weeks) | OS is the time from surgical diagnosis to the date of death from any cause. For participants who were alive, OS was censored at the last contact. |
| Secondary | Phase 1 - Number of Participants With Adverse Events (AEs) | Every cycle (up to 12 cycles, 28 days per cycle) | Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module. |
| Secondary | Phase 1 and 2: Association Between Biomarkers and Clinical Outcome | Baseline, Cycle 2, end of study (up to 12 cycles, 28 days per cycle) | Phosphorylated-S6 (pS6) ribosomal protein is a biomarker that's being investigated as a potential marker for clinical outcome using 2211 or 2215 antibody to pS6. Reported here are the hazard ratios and 95% confidence intervals (CIs) for participants for whom an pS6 immunohistochemistry (IHC) score was available. The IHC assays were scored using a 0 to +3 scoring system (no positive staining was scored 0; at least 25% immunoreactivity of cells was scored +1; 26% to 75% was scored +2; and 76% or greater was scored +3). Hazard ratio (HR) \> 1 indicates worse outcome for that IHC score. |
| Secondary | Phase 1 - Response Rate With Macdonald Criteria | Baseline, following radiation, every other cycle (up to 12 cycles, 28 days per cycle) | Response categories: complete response (CR): disappearance of all enhancing tumor on consecutive magnetic resonance imaging (MRI) scans at least 1 month apart, off steroids, and neurologically stable or improved. Partial response (PR): 50% reduction in size of enhancing tumor on consecutive MRI scans at least 1 month apart, steroids stable or reduced, and neurologically stable or improved. Progressive disease (PD): \>25% increase in size of enhancing tumor or any new tumor on MRI scans, or neurologically worse, and steroids stable or increased. Stable disease (SD): all other situations. |
| Secondary | Phase 2 - Number of Participants With Adverse Events (AEs) | Every cycle (28 days per cycle) | Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module. |
| Secondary | Number of Participants Undergoing Magnetic Resonance Imaging/Magnetic Resonance Spectroscopy (MRI/MRS) for Clinical Evaluation at Baseline | Each radiologic assessment (up to 12 cycles, 28 days per cycle) | Number of patients having MRI/MRS for clinical evaluation with baseline assessment. |
| Secondary | Phase 1 and 2 - Progression-Free Survival (PFS) | Baseline to measured progressive disease (up to 12 cycles, 28 days per cycle) | PFS was defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. |
| Secondary | Functional Assessment of Cancer Therapy - Brain (FACT-Br) | Every cycle (up to 12 cycles, 28 days per cycle) | Total FACT-Br score includes physical well-being, social/family well-being, emotional well-being, functional well-being and additional concerns related to brain tumors. The score ranges 0 to 200, with a higher score representing better quality of life. |
| Secondary | M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT) | Every cycle (up to 12 cycles, 28 days per cycle) | General and brain tumor-specific symptoms each assessed on a scale of 0 to 10, with a higher score representing higher symptom burden. The 4 symptom scales reported as changing over the course of the study are listed here. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1- Determination of the Maximum Tolerated Dose (MTD) of Enzastaurin | Until MTD can be determined (up to 12 cycles, 28 days per cycle) | All Phase I participants who received at least one dose of study drug. | milligrams (mg) | NUMBER |
| PRIMARY | Phase 1 and Phase 2 - Overall Survival (OS) | Baseline to death from any cause (Up to 48 weeks) | Phase 2 participants combined with Phase 1 cohort 1 participants who also received 250 mg enzastaurin. | months | MEDIAN |
| SECONDARY | Phase 1 - Number of Participants With Adverse Events (AEs) | Every cycle (up to 12 cycles, 28 days per cycle) | All Phase I participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 1 and 2: Association Between Biomarkers and Clinical Outcome | Baseline, Cycle 2, end of study (up to 12 cycles, 28 days per cycle) | Combined Phases 1 and 2 populations for whom IHC scores were obtained. HR \> 1 indicates poorer overall survival for that IHC score. | Hazard ratio | NUMBER |
| SECONDARY | Phase 1 - Response Rate With Macdonald Criteria | Baseline, following radiation, every other cycle (up to 12 cycles, 28 days per cycle) | Efficacy analysis in phase I was not conducted. Instead, participants who took 250mg in phase I were pooled with phase II participants and are presented in other outcome measures (2 and 8, respectively) in this record. Thus there were 0 participants for this measure. | ||
| SECONDARY | Phase 2 - Number of Participants With Adverse Events (AEs) | Every cycle (28 days per cycle) | All Phase 2 participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Undergoing Magnetic Resonance Imaging/Magnetic Resonance Spectroscopy (MRI/MRS) for Clinical Evaluation at Baseline | Each radiologic assessment (up to 12 cycles, 28 days per cycle) | 35 patients underwent MRI and had baseline measurement. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 1 and 2 - Progression-Free Survival (PFS) | Baseline to measured progressive disease (up to 12 cycles, 28 days per cycle) | Phase 2 participants combined with Phase 1 cohort 1 participants who also received 250 mg enzastaurin. | months | MEDIAN |
| SECONDARY | Functional Assessment of Cancer Therapy - Brain (FACT-Br) | Every cycle (up to 12 cycles, 28 days per cycle) | All treated participants who received at least one dose of study drug in the 250 mg enzastaurin cohort from Phases 1 and 2 combined and who also provided FACT-Br data from at least 1 visit (N = 65). One participant lacked these data. | units on a scale | MEAN |
| SECONDARY | M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT) | Every cycle (up to 12 cycles, 28 days per cycle) | units on a scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group106
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1- Determination of the Maximum Tolerated Dose (MTD) of Enzastaurin | Phase 1 Participants | 250 | milligrams (mg) | ||
| Phase 1 and Phase 2 - Overall Survival (OS) | 250 mg Enzastaurin Phases 1 and 2 Combined | 18.3 | 95% Confidence Interval 15.2 to 19.3 | months | |
| Phase 1 - Number of Participants With Adverse Events (AEs) | Phase 1- Cohort 1 (250 mg Enzastaurin) | 0 | Participants | ||
| Phase 1 - Number of Participants With Adverse Events (AEs) | Phase 1 Cohort 2 (500 mg Enzastaurin ) | 1 | Participants | ||
| Phase 1 and 2: Association Between Biomarkers and Clinical Outcome | 250 mg Enzastaurin Phases 1 and 2 Combined | S6 2211 score | 1.70 | 95% Confidence Interval 1.05 to 2.77 | Hazard ratio |
| Phase 1 and 2: Association Between Biomarkers and Clinical Outcome | 250 mg Enzastaurin Phases 1 and 2 Combined | S6 2215 score | 1.69 | 95% Confidence Interval 1.08 to 2.66 | Hazard ratio |
| Phase 2 - Number of Participants With Adverse Events (AEs) | Phase 2 - 250 mg Enzastaurin | 22 | Participants | ||
| Number of Participants Undergoing Magnetic Resonance Imaging/Magnetic Resonance Spectroscopy (MRI/MRS) for Clinical Evaluation at Baseline | Phase 2 - 250 mg | 35 | Participants | ||
| Phase 1 and 2 - Progression-Free Survival (PFS) | 250 mg Enzastaurin Phases 1 and 2 Combined | 10.6 | 95% Confidence Interval 8.4 to 12.7 | months | |
| Functional Assessment of Cancer Therapy - Brain (FACT-Br) | 250 mg Enzastaurin Phases 1 and 2 Combined | Baseline visit | 153.5 | Standard Deviation 24.08 | units on a scale |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1- Cohort 1 (250 mg Enzastaurin) | 6 | |
| Overall Study | STARTED | Phase 1 Cohort 2 (500 mg Enzastaurin) | 6 | |
| Overall Study | STARTED | Phase 2 | 60 | |
| Overall Study | COMPLETED | Phase 1- Cohort 1 (250 mg Enzastaurin) | 3 | |
| Overall Study | COMPLETED | Phase 1 Cohort 2 (500 mg Enzastaurin) | 0 | |
| Overall Study | COMPLETED | Phase 2 | 5 | |
| Overall Study | NOT COMPLETED | Phase 1- Cohort 1 (250 mg Enzastaurin) | 3 | |
| Overall Study | NOT COMPLETED | Phase 1 Cohort 2 (500 mg Enzastaurin) | 6 | |
| Overall Study | NOT COMPLETED | Phase 2 | 55 |
Source ClinicalTrials.gov
Adverse events525
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 | Leukopenia | Blood and lymphatic system disorders | Phase 1- Cohort 1 (250 mg Enzastaurin) | 4 | 6 | 4 |
| other | Leukopenia | Blood and lymphatic system disorders | Phase 1 Cohort 2 (500 mg Enzastaurin) | 4 | 6 | 4 |
| other | Leukopenia | Blood and lymphatic system disorders | Phase 2 - 250 mg Enzastaurin | 16 | 60 | 16 |
| other | Lymphopenia | Blood and lymphatic system disorders | Phase 1- Cohort 1 (250 mg Enzastaurin) | 5 | 6 | 5 |
| other | Lymphopenia | Blood and lymphatic system disorders | Phase 1 Cohort 2 (500 mg Enzastaurin) | 6 | 6 | 6 |
| other | Lymphopenia | Blood and lymphatic system disorders | Phase 2 - 250 mg Enzastaurin | 52 | 60 | 52 |
| other | Cardiac disorder | Cardiac disorders | Phase 1- Cohort 1 (250 mg Enzastaurin) | 1 | 6 | 1 |
| other | Cardiac disorder | Cardiac disorders | Phase 1 Cohort 2 (500 mg Enzastaurin) | 0 | 6 | 0 |
| other | Cardiac disorder | Cardiac disorders | Phase 2 - 250 mg Enzastaurin | 0 | 60 | 0 |
| other | Auditory disorder | Ear and labyrinth disorders | Phase 1- Cohort 1 (250 mg Enzastaurin) | 1 | 6 | 1 |
1 to 10 of 525Source ClinicalTrials.gov
See all 525 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1- Cohort 1 (250 mg Enzastaurin) | ||
| Total, all-cause mortality | Phase 1 Cohort 2 (500 mg Enzastaurin) | ||
| Total, all-cause mortality | Phase 2 - 250 mg Enzastaurin | ||
| Total, other adverse events | Phase 1- Cohort 1 (250 mg Enzastaurin) | 6 | 6 |
| Total, other adverse events | Phase 1 Cohort 2 (500 mg Enzastaurin) | 6 | 6 |
| Total, other adverse events | Phase 2 - 250 mg Enzastaurin | 60 | 60 |
| Total, serious adverse events | Phase 1- Cohort 1 (250 mg Enzastaurin) | 0 | 6 |
| Total, serious adverse events | Phase 1 Cohort 2 (500 mg Enzastaurin) | 1 | 6 |
| Total, serious adverse events | Phase 2 - 250 mg Enzastaurin | 22 | 60 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|
| Phase 1- Cohort 1 (250 mg Enzastaurin) vs Phase 1 Cohort 2 (500 mg Enzastaurin ): Phase 1 - Number of Participants With Adverse Events (AEs) |
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/NCT00402116
GET https://conductscience.org/api/trials/v1/NCT00402116/results?page=2