Trial · NCT00940225
Study of Cabozantinib (XL184) in Adults With Advanced Malignancies
NCT00940225, Phase 2, Completed, Exelixis; results first posted 2024-04-25
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of Cabozantinib (XL184) in Adults With Advanced Malignancies. Trials, record NCT00940225. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00940225
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Cabozantinib (XL184) in Adults With Advanced Malignancies
- NCT number
- NCT00940225
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 730 participants, actual
- Lead sponsor
- Exelixis
- Conditions
- Solid Tumors, Cancer
- Interventions
- Cabozantinib, Placebo
- First posted
- 2009-07-15
- Last updated
- 2024-04-25
- Results first posted
- 2024-04-25
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort Only | From initial dose through final study visit up to 44 months | Objective response rate (ORR) per modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.0 per investigator The analysis of ORR in the RDT Cohorts were defined as the proportion of subjects with a best overall response of confirmed complete response (CR) or partial response (PR) per mRECIST 1.0 during the 12-week Lead-In Stage. In the NRE Ovarian Cohort, mRECIST 1.1 was used. ORR for the NRE CRPC Cohorts was not a primary objective and is therefore not captured in the table below. |
| Primary | Bone Scan Response (BSR) - NRE, CRPC | From initial dose through final study visit up to 15 months | The reduction of bone scan lesion area (BSLA) by \> 30% was used as the quantitative measure of BSR. BSR was a primary outcome measure for only the NRE CRPC Cohorts. |
| Primary | Progression-Free Survival (PFS) - Randomized Stage, RDT Cohorts Only | From initial dose through final study visit up to 44 months | Progression Free Survival during the Randomized Stage (Randomized Population) |
| Secondary | Duration of Objective Response (OR) - Responders From Lead-in Stage | From initial dose through final study visit up to 44 months | Duration of objective response was defined as the time from the tumor assessment that first documented PR or CR that was subsequently confirmed at least 28 days later until the date of documented progression. There were either few or no responders in the Gastric/GEJ, SCLC, and pancreatic cohorts so these cohorts are excluded. |
| Secondary | Progression Free Survival (PFS) - Throughout the Study | From initial dose through final study visit up to 44 months | Progression-free survival (PFS) from first dose throughout the study was estimated for all subjects (safety population) using a piecewise method. |
| Secondary | Duration of Bone Scan Response - NRE Cohorts, CRPC Only | From initial dose through final study visit up to 15 months | The duration of BSR per IRF was calculated for CRPC subjects with an objective response (CR or PR) during the study. |
| Secondary | Overall Survival (OS) - NRE Cohorts, CRPC and Ovarian Only | From initial dose through final study visit up to 15 months |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort Only | From initial dose through final study visit up to 44 months | percentage of participants | NUMBER | |
| PRIMARY | Bone Scan Response (BSR) - NRE, CRPC | From initial dose through final study visit up to 15 months | percentage of participants | NUMBER | |
| PRIMARY | Progression-Free Survival (PFS) - Randomized Stage, RDT Cohorts Only | From initial dose through final study visit up to 44 months | months | MEDIAN | |
| SECONDARY | Duration of Objective Response (OR) - Responders From Lead-in Stage | From initial dose through final study visit up to 44 months | Months | MEDIAN | |
| SECONDARY | Progression Free Survival (PFS) - Throughout the Study | From initial dose through final study visit up to 44 months | months | MEDIAN | |
| SECONDARY | Duration of Bone Scan Response - NRE Cohorts, CRPC Only | From initial dose through final study visit up to 15 months | months | MEDIAN | |
| SECONDARY | Overall Survival (OS) - NRE Cohorts, CRPC and Ovarian Only | From initial dose through final study visit up to 15 months | months | MEDIAN |
Source ClinicalTrials.gov
Results by group50
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) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort Only | Lead-in Stage - CRPC | 4.7 | 95% Confidence Interval 2.0 to 8.7 | percentage of participants | |
| Objective Response Rate (ORR) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort Only | Lead-in Stage - Melanoma | 5.2 | 95% Confidence Interval 1.8 to 12.4 | percentage of participants | |
| Objective Response Rate (ORR) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort Only | Lead-in Stage - NSCLC | 10 | 95% Confidence Interval 4.4 to 20.3 | percentage of participants | |
| Objective Response Rate (ORR) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort Only | Lead-in Stage - Pancreatic Cancer | 0 | 95% Confidence Interval 0 to 15.4 | percentage of participants | |
| Objective Response Rate (ORR) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort Only | Lead-in Stage - Gastric/GEJ | 4.8 | 95% Confidence Interval 0.2 to 21.8 | percentage of participants | |
| Objective Response Rate (ORR) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort Only | Lead-in Stage - Hepatocellular Carcinoma | 4.9 | 95% Confidence Interval 0.9 to 16.1 | percentage of participants | |
| Objective Response Rate (ORR) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort Only | Lead-in Stage - SCLC | 4.8 | 95% Confidence Interval 0.2 to 21.8 | percentage of participants | |
| Objective Response Rate (ORR) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort Only | Lead-in Stage - Ovarian Cancer | 21.7 | 95% Confidence Interval 13.1 to 32.4 | percentage of participants | |
| Objective Response Rate (ORR) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort Only | Lead-in Stage - Metastatic Breast Cancer | 13.6 | 95% Confidence Interval 6.0 to 25.7 | percentage of participants | |
| Objective Response Rate (ORR) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort Only | Lead-in Stage - NRE Ovarian Cancer | 10.0 | 95% Confidence Interval 3.3 to 21.8 | percentage of participants |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RDT Cohort - Castration-Resistant Prostate Cancer (CRPC) | 171 | |
| Overall Study | STARTED | RDT Cohort - Melanoma | 77 | |
| Overall Study | STARTED | RDT Cohort - Non-Small Cell Lung Cancer (NSCLC) | 60 | |
| Overall Study | STARTED | RDT Cohort - Pancreatic Cancer | 20 | |
| Overall Study | STARTED | RDT Cohort - Gastric/Gastroesophageal Junction Cancer (GEJ) | 21 | |
| Overall Study | STARTED | RDT Cohort - Hepatocellular Carcinoma (HCC) | 41 | |
| Overall Study | STARTED | RDT Cohort - Small Cell Lung Cancer (SCLC) | 21 | |
| Overall Study | STARTED | RDT Cohort - Ovarian Cancer | 70 | |
| Overall Study | STARTED | RDT Cohort - Metastatic Breast Cancer (MBC) | 45 | |
| Overall Study | STARTED | NRE Cohort - CRPC 100 mg | 93 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events1,464
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 | RDT All Cohorts | 63 | 526 | |
| other | Anaemia | Blood and lymphatic system disorders | NRE Cohort - CRPC 100mg (Castration-Resistant Prostate Cancer) | 29 | 93 | |
| other | Anaemia | Blood and lymphatic system disorders | NRE Cohort - CRPC 39.4mg (Castration-Resistant Prostate Cancer) | 5 | 51 | |
| other | Anaemia | Blood and lymphatic system disorders | NRE Cohort - Ovarian 100mg | 10 | 60 | |
| other | Leukopenia | Blood and lymphatic system disorders | RDT All Cohorts | 27 | 526 | |
| other | Leukopenia | Blood and lymphatic system disorders | NRE Cohort - CRPC 100mg (Castration-Resistant Prostate Cancer) | 7 | 93 | |
| other | Leukopenia | Blood and lymphatic system disorders | NRE Cohort - CRPC 39.4mg (Castration-Resistant Prostate Cancer) | 3 | 51 | |
| other | Leukopenia | Blood and lymphatic system disorders | NRE Cohort - Ovarian 100mg | 5 | 60 | |
| other | Neutropenia | Blood and lymphatic system disorders | RDT All Cohorts | 35 | 526 | |
| other | Neutropenia | Blood and lymphatic system disorders | NRE Cohort - CRPC 100mg (Castration-Resistant Prostate Cancer) | 8 | 93 |
1 to 10 of 1,464Source ClinicalTrials.gov
See all 1,464 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RDT All Cohorts | 54 | 526 |
| Total, all-cause mortality | NRE Cohort - CRPC 100mg (Castration-Resistant Prostate Cancer) | 53 | 93 |
| Total, all-cause mortality | NRE Cohort - CRPC 39.4mg (Castration-Resistant Prostate Cancer) | 13 | 51 |
| Total, all-cause mortality | NRE Cohort - Ovarian 100mg | 33 | 60 |
| Total, other adverse events | RDT All Cohorts | 524 | 526 |
| Total, other adverse events | NRE Cohort - CRPC 100mg (Castration-Resistant Prostate Cancer) | 93 | 93 |
| Total, other adverse events | NRE Cohort - CRPC 39.4mg (Castration-Resistant Prostate Cancer) | 50 | 51 |
| Total, other adverse events | NRE Cohort - Ovarian 100mg | 59 | 60 |
| Total, serious adverse events | RDT All Cohorts | 223 | 526 |
| Total, serious adverse events | NRE Cohort - CRPC 100mg (Castration-Resistant Prostate Cancer) | 53 | 93 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers9
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 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/NCT00940225
GET https://conductscience.org/api/trials/v1/NCT00940225/results?page=2