Trial · NCT00709995
A Study for Participants With Metastatic Renal Cell Carcinoma
NCT00709995, Phase 2, Completed, Eli Lilly and Company; results first posted 2019-09-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study for Participants With Metastatic Renal Cell Carcinoma. Trials, record NCT00709995. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00709995
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study for Participants With Metastatic Renal Cell Carcinoma
- NCT number
- NCT00709995
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Metastatic Renal Cell Carcinoma
- Interventions
- Enzastaurin, Sunitinib, Placebo
- First posted
- 2008-07-03
- Last updated
- 2019-09-30
- Results first posted
- 2019-09-30
- Limitations and caveats
Part 1 completers finished 3 or more cycles and included those with progressive disease. Part 2 was not performed and was not activated due to sponsor broad decision to not pursue enzastaurin in solid tumors
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 (PFS) in Part 2 | Randomization to Measured Progressive Disease (PD) (Up to 24 Months) | Progression-free survival (PFS) was defined as the number of months between the date of randomization and the date of first documented disease progression or the date of death due to any cause, whichever came first. |
| Secondary | Overall Survival (OS) in Part 2 | Randomization to Death from Any Cause (Up to 24 Months) | OS time was defined as the number of months between the date of randomization and the date of death due to any cause. |
| Secondary | Time-To-Tumor Progression in Part 2 | Randomization to the Date of Objective Progressive Disease or Date of Death due to Study Disease, whichever came first (Up to 24 Months) | Time to tumor progression (TTP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. |
| Secondary | Number of Participants With Adverse Events (AEs) or Serious AEs (SAEs) in Part 1 | Randomization to Study Completion (Up to 6 Cycles) | Clinically significant events were defined as serious adverse events, regardless of causality. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module. |
| Secondary | Pharmacokinetics (PK): Area Under Concentration Time Curve During One Dosing Interval at Steady State (AUCτ,ss) of Enzastaurin + Metabolite (LSN326020) + Total Analytes in Part 1 | Cycle 1 Day 15: Predose, 2, 4, and 6 - 8 hours, Up to 12 Hours Post dose | Pharmacokinetics (PK) was assessed in participants to determine the area under the concentration time curve during one dosing interval at steady state (AUCτ,ss) of Enzastaurin, LSN326020 and total Analytes. τ equals 12 hours for Enzastaurin, LSN326020 and total Analytes. |
| Secondary | PK: Maximum Concentration at Steady State (Cmax,ss) of Enzastaurin + LSN326020 + Total Analytes in Part 1 | Cycle 1 Day 15: Predose, 2, 4, and 6 - 8 hours, Up to 12 Hours Post dose | PK was assessed in participants to determine the maximum concentration at steady state (Cmax, ss) of Enzastaurin + LSN326020 + total analytes. |
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 (PFS) in Part 2 | Randomization to Measured Progressive Disease (PD) (Up to 24 Months) | Zero participants data were collected. Part 2 was not activated due to sponsor broad decision to not pursue Enzastaurin in solid tumors. | ||
| SECONDARY | Overall Survival (OS) in Part 2 | Randomization to Death from Any Cause (Up to 24 Months) | Zero participant data were collected. Part 2 was not activated due to sponsor broad decision to not pursue Enzastaurin in solid tumors. | ||
| SECONDARY | Time-To-Tumor Progression in Part 2 | Randomization to the Date of Objective Progressive Disease or Date of Death due to Study Disease, whichever came first (Up to 24 Months) | Zero participant data were collected. Part 2 was not activated due to sponsor broad decision to not pursue Enzastaurin in solid tumors. | ||
| SECONDARY | Number of Participants With Adverse Events (AEs) or Serious AEs (SAEs) in Part 1 | Randomization to Study Completion (Up to 6 Cycles) | All randomized participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetics (PK): Area Under Concentration Time Curve During One Dosing Interval at Steady State (AUCτ,ss) of Enzastaurin + Metabolite (LSN326020) + Total Analytes in Part 1 | Cycle 1 Day 15: Predose, 2, 4, and 6 - 8 hours, Up to 12 Hours Post dose | All randomized participants who received at least one dose of study drug and had evaluable PK data. | nanomole*hour/liter (nmol*hr/L) | GEOMETRIC_MEAN |
| SECONDARY | PK: Maximum Concentration at Steady State (Cmax,ss) of Enzastaurin + LSN326020 + Total Analytes in Part 1 | Cycle 1 Day 15: Predose, 2, 4, and 6 - 8 hours, Up to 12 Hours Post dose | All randomized participants who received at least one dose of study drug and had evaluable PK data. | nanomole/liter (nmol/L) | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) or Serious AEs (SAEs) in Part 1 | Modified Regimen A (Cohort 1) | AEs | 11 | Participants | |
| Number of Participants With Adverse Events (AEs) or Serious AEs (SAEs) in Part 1 | Regimen A (Cohort 2) | AEs | 6 | Participants | |
| Number of Participants With Adverse Events (AEs) or Serious AEs (SAEs) in Part 1 | Modified Regimen A (Cohort 1) | SAEs | 3 | Participants | |
| Number of Participants With Adverse Events (AEs) or Serious AEs (SAEs) in Part 1 | Regimen A (Cohort 2) | SAEs | 1 | Participants | |
| Pharmacokinetics (PK): Area Under Concentration Time Curve During One Dosing Interval at Steady State (AUCτ,ss) of Enzastaurin + Metabolite (LSN326020) + Total Analytes in Part 1 | Modified Regimen A (Cohort 1) | Enzastaurin | 12000 | Geometric Coefficient of Variation 144 | nanomole*hour/liter (nmol*hr/L) |
| Pharmacokinetics (PK): Area Under Concentration Time Curve During One Dosing Interval at Steady State (AUCτ,ss) of Enzastaurin + Metabolite (LSN326020) + Total Analytes in Part 1 | Regimen A (Cohort 2) | Enzastaurin | 22600 | Geometric Coefficient of Variation 91 | nanomole*hour/liter (nmol*hr/L) |
| Pharmacokinetics (PK): Area Under Concentration Time Curve During One Dosing Interval at Steady State (AUCτ,ss) of Enzastaurin + Metabolite (LSN326020) + Total Analytes in Part 1 | Modified Regimen A (Cohort 1) | LSN326020 | 8820 | Geometric Coefficient of Variation 76 | nanomole*hour/liter (nmol*hr/L) |
| Pharmacokinetics (PK): Area Under Concentration Time Curve During One Dosing Interval at Steady State (AUCτ,ss) of Enzastaurin + Metabolite (LSN326020) + Total Analytes in Part 1 | Regimen A (Cohort 2) | LSN326020 | 12200 | Geometric Coefficient of Variation 73 | nanomole*hour/liter (nmol*hr/L) |
| Pharmacokinetics (PK): Area Under Concentration Time Curve During One Dosing Interval at Steady State (AUCτ,ss) of Enzastaurin + Metabolite (LSN326020) + Total Analytes in Part 1 | Modified Regimen A (Cohort 1) | Total Analytes | 21400 | Geometric Coefficient of Variation 101 | nanomole*hour/liter (nmol*hr/L) |
| Pharmacokinetics (PK): Area Under Concentration Time Curve During One Dosing Interval at Steady State (AUCτ,ss) of Enzastaurin + Metabolite (LSN326020) + Total Analytes in Part 1 | Regimen A (Cohort 2) | Total Analytes | 35200 | Geometric Coefficient of Variation 82 | nanomole*hour/liter (nmol*hr/L) |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Modified Regimen A (Cohort 1) | 11 | |
| Overall Study | STARTED | Regimen A (Cohort 2) | 6 | |
| Overall Study | Progressive Disease | Modified Regimen A (Cohort 1) | 6 | |
| Overall Study | Progressive Disease | Regimen A (Cohort 2) | 1 | |
| Overall Study | COMPLETED | Modified Regimen A (Cohort 1) | 6 | |
| Overall Study | COMPLETED | Regimen A (Cohort 2) | 1 | |
| Overall Study | NOT COMPLETED | Modified Regimen A (Cohort 1) | 5 | |
| Overall Study | NOT COMPLETED | Regimen A (Cohort 2) | 5 |
Source ClinicalTrials.gov
Adverse events236
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 | Anaemia | Blood and lymphatic system disorders | Modified Regimen A (Cohort 1) | 8 | 11 | 33 |
| other | Anaemia | Blood and lymphatic system disorders | Regimen A (Cohort 2) | 4 | 6 | 10 |
| other | Leukopenia | Blood and lymphatic system disorders | Modified Regimen A (Cohort 1) | 3 | 11 | 4 |
| other | Leukopenia | Blood and lymphatic system disorders | Regimen A (Cohort 2) | 0 | 6 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | Modified Regimen A (Cohort 1) | 1 | 11 | 2 |
| other | Lymphopenia | Blood and lymphatic system disorders | Regimen A (Cohort 2) | 0 | 6 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Modified Regimen A (Cohort 1) | 5 | 11 | 7 |
| other | Neutropenia | Blood and lymphatic system disorders | Regimen A (Cohort 2) | 1 | 6 | 87 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Modified Regimen A (Cohort 1) | 9 | 11 | 20 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Regimen A (Cohort 2) | 2 | 6 | 32 |
1 to 10 of 236Source ClinicalTrials.gov
See all 236 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Modified Regimen A (Cohort 1) | ||
| Total, all-cause mortality | Regimen A (Cohort 2) | ||
| Total, other adverse events | Modified Regimen A (Cohort 1) | 11 | 11 |
| Total, other adverse events | Regimen A (Cohort 2) | 6 | 6 |
| Total, serious adverse events | Modified Regimen A (Cohort 1) | 3 | 11 |
| Total, serious adverse events | Regimen A (Cohort 2) | 1 | 6 |
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 |
|---|
| Modified Regimen A (Cohort 1) vs Regimen A (Cohort 2): 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/NCT00709995
GET https://conductscience.org/api/trials/v1/NCT00709995/events?page=2