Trial · NCT01137604
A Study in Subjects With Recurrent Malignant Glioma
NCT01137604, Phase 2, Completed, Eisai Inc.; results first posted 2016-05-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study in Subjects With Recurrent Malignant Glioma. Trials, record NCT01137604. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01137604
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study in Subjects With Recurrent Malignant Glioma
- NCT number
- NCT01137604
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 151 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Glioma
- Interventions
- Lenvatinib, Bevacizumab
- First posted
- 2010-06-04
- Last updated
- 2022-09-29
- Results first posted
- 2016-05-23
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) Rate at Month 6 | At Month 6 from randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) | PFS at Month 6 was defined as the percentage of participants who remained alive and progression-free at Month 6, based on investigator's assessment. Progression was defined using Response Assessment in Neuro-Oncology (RANO) criteria, as a greater than 25% increase in enhancing lesions despite stable or increasing steroid dose, an increase (significant) in non-enhancing T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR) lesions that are not attributable to other non-tumor causes, and any new lesions. PFS rate at Month 6 was estimated from Kaplan-Meier (K-M) product-limit estimate of PFS. |
| Secondary | Objective Response Rate (ORR) | From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (i.e., 2.4 years) | ORR was the percentage of participants with best overall response (BOR) of complete response (CR) and partial response (PR) based on RANO criteria and investigator's assessment. CR was defined as the disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks, no new lesions, and stable or improved non-enhancing (T2/FLAIR) lesions. PR was defined as greater than or equal to 50% decrease, compared to baseline, in the sum of products of perpendicular diameters of all measureable enhancing lesions sustained for at least 4 weeks. No progression of non-measurable disease, no new lesions, stable or improved non-enhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared to baseline. For both CR and PR, in the absence of a confirming scan 4 weeks later, this scan was considered only stable disease. Only participants with measureable disease at baseline were included in evaluation of ORR. |
| Secondary | Progression Free Survival | From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years) | PFS was measured as the time from randomization (Cohort 1) or the first day of treatment (Cohorts 2 and 3) until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression, based on investigator's assessment. |
| Secondary | Overall Survival (OS) | From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until death due to any cause or up to data cutoff date of 19 March 2013 (ie, 2.4 years) | OS was measured as the time from the randomization date (Cohort 1) or the first day of treatment (Cohort 2 and 3) to the date of death from any cause. |
| Secondary | Disease Control Rate (DCR) | From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years) | DCR was the percentage of the participants who had BOR of CR, PR, and stable disease (SD) with the minimum duration of SD lasting greater than or equal to 7 weeks. Only participants with measurable disease at baseline were included in evaluation of DCR, based on investigator's assessment. |
| Secondary | Clinical Benefit Rate (CBR) | From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years) | CBR was the percentage of the participants who had BOR of CR, PR, and SD with the minimum duration of SD lasting greater than or equal to 23 weeks. Only participants with measurable disease at baseline were included in evaluation of CBR, based on investigator's assessment. |
| Secondary | Number of Participants With Adverse Events (AEs)/Serious Adverse Events (SAEs) as a Measure of Safety | For each participant, from the first patient first dose till 30 days after the last dose or the cut-off date of 19 March 2013 (ie, 2.4 years) | Safety was assessed by monitoring and recording all AEs including all Common Terminology Criteria for Adverse Events (CTCAE) grades (for both increasing and decreasing severity) and SAEs; regular monitoring of hematology, clinical chemistry, and urine values; results of physical examinations, regular measurement of vital signs, and electrocardiograms (ECGs), as detailed in the Schedule of Visits and Procedures. The relationship of AEs to treatment was based on investigator judgment. Details of AEs and SAEs are provided in the reported adverse event section. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Objective Response Rate (ORR) | From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (i.e., 2.4 years) | Full Analysis Set included all participants who received at least one dose of study drug | Percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival | From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years) | Full Analysis Set - all participants who received at least one dose of study drug | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until death due to any cause or up to data cutoff date of 19 March 2013 (ie, 2.4 years) | Full Analysis Set - all participants who received at least one dose of study drug | Months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years) | Full Analysis Set - all participants who received at least one dose of study drug | Percentage of participants | NUMBER |
| SECONDARY | Clinical Benefit Rate (CBR) | From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years) | Full Analysis Set - all participants who received at least one dose of study drug | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs)/Serious Adverse Events (SAEs) as a Measure of Safety | For each participant, from the first patient first dose till 30 days after the last dose or the cut-off date of 19 March 2013 (ie, 2.4 years) | Full Analysis Set - all participants who received at least one dose of study drug | Participants | NUMBER |
| PRIMARY | Progression Free Survival (PFS) Rate at Month 6 | At Month 6 from randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) | Full Analysis Set included all participants who received at least one dose of study drug | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Cohort 1 - Bevacizumab | 15.8 | 95% Confidence Interval 6.0 to 31.3 | Percentage of participants | |
| Objective Response Rate (ORR) | Cohort 1 - Lenvatinib | 21.4 | 95% Confidence Interval 10.3 to 36.8 | Percentage of participants | |
| Objective Response Rate (ORR) | Cohort 2 - Lenvatinib | 7.7 | 95% Confidence Interval 1.6 to 20.9 | Percentage of participants | |
| Objective Response Rate (ORR) | Cohort 3 - Lenvatinib | 0.0 | 95% Confidence Interval 0.0 to 10.9 | Percentage of participants | |
| Progression Free Survival | Cohort 1 - Bevacizumab | 2.8 | 95% Confidence Interval 1.9 to 3.6 | Months | |
| Progression Free Survival | Cohort 1 - Lenvatinib | 2.4 | 95% Confidence Interval 1.8 to 3.6 | Months | |
| Progression Free Survival | Cohort 2 - Lenvatinib | 2.8 | 95% Confidence Interval 1.9 to 3.7 | Months | |
| Progression Free Survival | Cohort 3 - Lenvatinib | 1.8 | 95% Confidence Interval 1.0 to 2.5 | Months | |
| Overall Survival (OS) | Cohort 1 - Bevacizumab | 6.0 | 95% Confidence Interval 4.5 to 7.7 | Months | |
| Overall Survival (OS) | Cohort 1 - Lenvatinib | 7.5 | 95% Confidence Interval 5.6 to 11.6 | Months |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 - Bevacizumab | 38 | |
| Overall Study | STARTED | Cohort 1 - Lenvatinib | 42 | |
| Overall Study | STARTED | Cohort 2 - Lenvatinib | 39 | |
| Overall Study | STARTED | Cohort 3 - Lenvatinib | 32 | |
| Overall Study | Treatment Discontinued Due to Disease Progression | Cohort 1 - Bevacizumab | 34 | |
| Overall Study | Treatment Discontinued Due to Disease Progression | Cohort 1 - Lenvatinib | 32 | |
| Overall Study | Treatment Discontinued Due to Disease Progression | Cohort 2 - Lenvatinib | 26 | |
| Overall Study | Treatment Discontinued Due to Disease Progression | Cohort 3 - Lenvatinib | 21 | |
| Overall Study | COMPLETED | Cohort 1 - Bevacizumab | 34 | |
| Overall Study | COMPLETED | Cohort 1 - Lenvatinib | 32 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events704
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 | Cohort 1 - Bevacizumab | 2 | 38 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1 - Lenvatinib | 2 | 42 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2 - Lenvatinib | 0 | 39 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 3 - Lenvatinib | 2 | 32 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 1 - Bevacizumab | 1 | 38 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 1 - Lenvatinib | 1 | 42 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 2 - Lenvatinib | 2 | 39 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 3 - Lenvatinib | 6 | 32 | |
| other | Sinus tachycardia | Cardiac disorders | Cohort 1 - Bevacizumab | 2 | 38 | |
| other | Sinus tachycardia | Cardiac disorders | Cohort 1 - Lenvatinib | 1 | 42 |
1 to 10 of 704Source ClinicalTrials.gov
See all 704 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 - Bevacizumab | 36 | 38 |
| Total, all-cause mortality | Cohort 1 - Lenvatinib | 38 | 42 |
| Total, all-cause mortality | Cohort 2 - Lenvatinib | 27 | 39 |
| Total, all-cause mortality | Cohort 3 - Lenvatinib | 30 | 32 |
| Total, other adverse events | Cohort 1 - Bevacizumab | 38 | 38 |
| Total, other adverse events | Cohort 1 - Lenvatinib | 40 | 42 |
| Total, other adverse events | Cohort 2 - Lenvatinib | 39 | 39 |
| Total, other adverse events | Cohort 3 - Lenvatinib | 31 | 32 |
| Total, serious adverse events | Cohort 1 - Bevacizumab | 10 | 38 |
| Total, serious adverse events | Cohort 1 - Lenvatinib | 22 | 42 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01137604
GET https://conductscience.org/api/trials/v1/NCT01137604/results?page=2