Trial · NCT01068782
Multiple Doses and Regimens of Cabozantinib in Subjects With Grade IV Astrocytic Tumors in First or Second Relapse
NCT01068782, Phase 2, Terminated, Exelixis; results first posted 2026-02-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Multiple Doses and Regimens of Cabozantinib in Subjects With Grade IV Astrocytic Tumors in First or Second Relapse. Trials, record NCT01068782. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01068782
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multiple Doses and Regimens of Cabozantinib in Subjects With Grade IV Astrocytic Tumors in First or Second Relapse
- NCT number
- NCT01068782
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- Exelixis
- Conditions
- Astrocytic Tumors
- Interventions
- Cabozantinib
- First posted
- 2010-02-15
- Last updated
- 2026-02-25
- Results first posted
- 2026-02-25
- Limitations and caveats
The enrollment in this study was terminated for business development reasons before enrolling one third of the expected participant population. No efficacy data were collected and limited safety data were collected.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Randomized Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to 13 months | An AE was defined as any event with an onset date on or after the date of first dose of study drug, or any ongoing event on the date of first dose that worsened in severity after the date of first dose. TEAEs were defined as AEs that started on or after the first administration of study drug up to the date of last dose plus 30 days. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. |
| Primary | Expansion Phase: Objective Response Rate (ORR) | Up to 13 months | ORR was defined as the number of participants for whom the best overall response at the time of data cutoff is confirmed complete response (CR) or confirmed partial response (PR) as assessed per modified Response Assessment in Neuro-Oncology (RANO) criteria. CR = Disappearance of all enhancing target lesion(s) and no glucocorticoids (other than a physiologic replacement dose of a maximum of 1.2 mg dexamethasone equivalent dose per day) taken for the 5 days immediately preceding the date of the current magnetic resonance imaging (MRI). PR = ≥50% decrease in the sum of the products of perpendicular diameters of all target enhancing lesions on the current MRI scan compared to the baseline MRI scan and glucocorticoids stable or decreased. The sponsor terminated the study early due to business reasons before entering the expansion phase. As such, no data were collected for efficacy analyses. |
| Secondary | Expansion Phase: Progression Free Survival at 6 Months as Per Independent Radiology Facility | Month 6 | Progression-free survival at 6 months (PFS6) was defined as the proportion of participants alive and progression-free 182 days after Study Day 1. The sponsor terminated the study early due to business reasons before entering the expansion phase. As such, no data were collected for efficacy analyses. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Randomized Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to 13 months | The safety population included all participants who enrolled and received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Expansion Phase: Objective Response Rate (ORR) | Up to 13 months | Decision was made to terminate the study prior to entering the expansion phase. As such, no data were collected or analyzed as planned for this outcome measure. | ||
| SECONDARY | Expansion Phase: Progression Free Survival at 6 Months as Per Independent Radiology Facility | Month 6 | Decision was made to terminate the study prior to entering the expansion phase. As such, no data were collected or analyzed as planned for this outcome measure. |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Randomized Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Arm 1 | 5 | Participants | ||
| Randomized Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Arm 2 | 3 | Participants | ||
| Randomized Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Arm 3 | 6 | Participants | ||
| Randomized Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Arm 4 | 4 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1 - Cabozantinib, 25 mg | 5 | |
| Overall Study | STARTED | Arm 2 - Cabozantinib, 75 mg | 4 | |
| Overall Study | STARTED | Arm 3 - Cabozantinib, 125 mg | 6 | |
| Overall Study | STARTED | Arm 4 - Cabozantinib, 125 mg, QD for 2 Weeks, Followed by 1 Week Off | 4 | |
| Overall Study | COMPLETED | Arm 1 - Cabozantinib, 25 mg | 0 | |
| Overall Study | COMPLETED | Arm 2 - Cabozantinib, 75 mg | 0 | |
| Overall Study | COMPLETED | Arm 3 - Cabozantinib, 125 mg | 0 | |
| Overall Study | COMPLETED | Arm 4 - Cabozantinib, 125 mg, QD for 2 Weeks, Followed by 1 Week Off | 0 | |
| Overall Study | NOT COMPLETED | Arm 1 - Cabozantinib, 25 mg | 5 | |
| Overall Study | NOT COMPLETED | Arm 2 - Cabozantinib, 75 mg | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events488
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 | Arm 1 | 1 | 5 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm 2 | 0 | 4 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm 3 | 1 | 6 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm 4 | 1 | 4 | |
| other | Neutropenia | Blood and lymphatic system disorders | Arm 1 | 1 | 5 | |
| other | Neutropenia | Blood and lymphatic system disorders | Arm 2 | 1 | 4 | |
| other | Neutropenia | Blood and lymphatic system disorders | Arm 3 | 1 | 6 | |
| other | Neutropenia | Blood and lymphatic system disorders | Arm 4 | 1 | 4 | |
| other | Bundle branch block right | Cardiac disorders | Arm 1 | 0 | 5 | |
| other | Bundle branch block right | Cardiac disorders | Arm 2 | 0 | 4 |
1 to 10 of 488Source ClinicalTrials.gov
See all 488 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1 | 0 | 5 |
| Total, all-cause mortality | Arm 2 | 0 | 4 |
| Total, all-cause mortality | Arm 3 | 0 | 6 |
| Total, all-cause mortality | Arm 4 | 0 | 4 |
| Total, other adverse events | Arm 1 | 5 | 5 |
| Total, other adverse events | Arm 2 | 3 | 4 |
| Total, other adverse events | Arm 3 | 6 | 6 |
| Total, other adverse events | Arm 4 | 4 | 4 |
| Total, serious adverse events | Arm 1 | 2 | 5 |
| Total, serious adverse events | Arm 2 | 1 | 4 |
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/NCT01068782
GET https://conductscience.org/api/trials/v1/NCT01068782/events?page=2