Trial · NCT00704730
Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer
NCT00704730, Phase 3, Completed, Exelixis; results first posted 2014-09-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer. Trials, record NCT00704730. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00704730
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer
- NCT number
- NCT00704730
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 330 participants, actual
- Lead sponsor
- Exelixis
- Conditions
- Thyroid Cancer
- Interventions
- XL184, Placebo
- First posted
- 2008-06-25
- Last updated
- 2021-04-20
- Results first posted
- 2014-09-09
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) | Treatment period consisted of 4-week cycles with radiologic tumor assessment every 12 weeks from date of randomization until date of first documented PD or date of death from any cause, whichever came first, assessed up to 34 months. | The duration of Progression-Free Survival (PFS) using progression events as determined by Independent Review Committee (IRC) per mRECIST, or death due to any cause. The analysis was conducted after at least 315 subjects were randomized and at least 138 events were observed. |
| Secondary | Overall Survival (OS) With XL184 Compared With Placebo | The pre-specified interim analysis of Overall Survival (OS) was assessed at 44% of required events. Includes data up to 15June2011. As of this date, the number of deaths required to conduct the primary analysis had not been reached. | Duration of Overall Survival (OS) from the time of randomization to death due to any cause. A Kaplan-Meier analysis was performed to estimate the median. |
| Secondary | Objective Response Rate (ORR) | Assessed at the same time as primary analysis of Progression Free Survival (PFS) data. Assessed at baseline and every 12 weeks until Progressive Disease (PD) up to 34 months. | The proportion of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as determined by the Independent Review Committee (IRC.) Per Response Evaluation Criteria in Solid Tumor Criteria (mRECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) ≥ 20% increase in the sum of the longest diameter of target lesions. Overall Response Rate: ORR=CR +PR |
| Secondary | Duration of Objective Response (OR): Independent Radiology Committee (IRC) Determined | From time of first documentation of Objective Response (OR), confirmed at a later visit ≥28 days later as Progressive Disease (PD) as defined by mRECIST or death due to any cause, assessed up to 34 months. | For those subjects with Independent Radiology Committee (IRC) determined Objective Response Rate (ORR), the amount of time from documentation of Objective Response (OR) until Progressive Disease (PD) by mRECIST or death due to any cause. |
| Secondary | Biochemical Response Calcitonin (CTN) % | Serum tumor markers CTN evaluated from blood samples collected at screening and every 12 weeks (±5 days from randomization) until date of first documented progression or date of death from any cause, whichever came first, assessed for up to 34 months. | For each on-treatment tumor marker assessment from each subject, the biochemical response of CTN was determined based on percent increase or decrease from baseline. Best biochemical response over course of treatment was determined from evaluation of subject's time point response data. Biochemical response criteria: Complete Response (CR) - decrease in tumor marker into normal range from baseline value; Partial Response (PR) - decrease of \>50% from baseline value when baseline value is above normal range; Stable Disease (SD) - no more than a 50% increase and no more than a 50% decrease from baseline value above normal range; Progressive Disease (PD) - increase of \>50% from baseline value when baseline value is above normal range / or increase from low or normal range at baseline to above normal range; Not Evaluable (NE) - missing baseline value / or baseline value is not elevated and response is not PD / or response can not be determined due to change in assay format. |
| Secondary | Biochemical Response Carcinoembryonic Antigen (CEA) % | Serum tumor markers CEA evaluated from blood samples collected at screening and every 12 weeks (± 5 days from randomization) until date of first documented progression or date of death from any cause, whichever came first, assessed for up to 34 months. | For each on-treatment tumor marker assessment from each subject, the biochemical response of CEA was determined based on percent increase or decrease from baseline. Best biochemical response over the course of treatment was determined from evaluation of each subject's time point response data. Biochemical response: Complete Response (CR)- Decrease in tumor marker into normal range from baseline value; Partial Response (PR)- Decrease of \>50% from baseline value when baseline value is above normal range; Stable Disease (SD)- No more than a 50% increase and no more than a 50% decrease from baseline value above normal range; Progressive Disease (PD)- Increase of \>50% from baseline value when baseline value is above normal range / or increase from low or normal range at baseline to above normal range; Not Evaluable (NE)- Missing baseline value / or baseline value is not elevated and response is not Progressive Disease (PD) / or response can not be determined due to change in assay format. |
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) | Treatment period consisted of 4-week cycles with radiologic tumor assessment every 12 weeks from date of randomization until date of first documented PD or date of death from any cause, whichever came first, assessed up to 34 months. | Intent to Treat (ITT) 330 subjects were randomized and were included in the analysis. A Kaplan-Meyer analysis was performed to estimate the median. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) With XL184 Compared With Placebo | The pre-specified interim analysis of Overall Survival (OS) was assessed at 44% of required events. Includes data up to 15June2011. As of this date, the number of deaths required to conduct the primary analysis had not been reached. | Intent to treat (ITT) randomized to either XL184 or placebo | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | Assessed at the same time as primary analysis of Progression Free Survival (PFS) data. Assessed at baseline and every 12 weeks until Progressive Disease (PD) up to 34 months. | The primary analysis Objective Response Rate (ORR) was performed among subset of Intent To Treat (ITT) subjects with measurable disease at baseline (N = 208 cabozantinib, N = 104 placebo) based upon response determined by Independent Radiology Committee (IRC.) Subjects without post-baseline adequate tumor assessments - counted as nonresponders. | % of participants | NUMBER |
| SECONDARY | Duration of Objective Response (OR): Independent Radiology Committee (IRC) Determined | From time of first documentation of Objective Response (OR), confirmed at a later visit ≥28 days later as Progressive Disease (PD) as defined by mRECIST or death due to any cause, assessed up to 34 months. | The primary analysis of Objective Response Rate (ORR) was performed among the subset of Intent To Treat (ITT) subjects with measurable disease at baseline and was based upon response as determined by the Independent Review Committee (IRC.) Subjects who did not have post-baseline adequate tumor assessments were counted as nonresponders. | months | MEDIAN |
| SECONDARY | Biochemical Response Calcitonin (CTN) % | Serum tumor markers CTN evaluated from blood samples collected at screening and every 12 weeks (±5 days from randomization) until date of first documented progression or date of death from any cause, whichever came first, assessed for up to 34 months. | Population was intent to treat (ITT), randomized to either XL184 or placebo. For the CTN measure the analysis population differs from the ITT population of 219 XL184 and 111 Placebo. Three subjects did not provide samples for CTN. The biomarker analysis was based on available samples, not on ITT. | % participants | NUMBER |
| SECONDARY | Biochemical Response Carcinoembryonic Antigen (CEA) % | Serum tumor markers CEA evaluated from blood samples collected at screening and every 12 weeks (± 5 days from randomization) until date of first documented progression or date of death from any cause, whichever came first, assessed for up to 34 months. | For the CEA measure the analysis population differs from the Intent To Treat (ITT) population of 219 XL184 and 111 Placebo. One subject did not provide samples for CEA. The biomarker analysis was based on available samples, not on ITT. | % of participants | NUMBER |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) | XL184 (Cabozantinib) | 11.2 | 95% Confidence Interval 9.3 to 13.7 | months | |
| Progression-Free Survival (PFS) | Placebo | 4.0 | 95% Confidence Interval 3.0 to 5.4 | months | |
| Overall Survival (OS) With XL184 Compared With Placebo | XL184 (Cabozantinib) | 21.1 | 95% Confidence Interval 16.59 to 28.52 | months | |
| Overall Survival (OS) With XL184 Compared With Placebo | Placebo | NA | 95% Confidence Interval 17.41 to NA | months | |
| Objective Response Rate (ORR) | XL184 (Cabozantinib) | 28 | 21.9 to 34.5 | % of participants | |
| Objective Response Rate (ORR) | Placebo | 0 | 0 to 0 | % of participants | |
| Duration of Objective Response (OR): Independent Radiology Committee (IRC) Determined | XL184 (Cabozantinib) | 14.6 | 95% Confidence Interval 11.1 to 17.5 | months | |
| Biochemical Response Calcitonin (CTN) % | XL184 (Cabozantinib) | 22.6 | 60.71 | % participants | |
| Biochemical Response Calcitonin (CTN) % | Placebo | 0.9 | 115.4 | % participants | |
| Biochemical Response Carcinoembryonic Antigen (CEA) % | XL184 (Cabozantinib) | 21.6 | 58.21 | % of participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | XL184 (Cabozantinib) | 219 | |
| Overall Study | STARTED | Placebo | 111 | |
| Overall Study | COMPLETED | XL184 (Cabozantinib) | 98 | |
| Overall Study | COMPLETED | Placebo | 15 | |
| Overall Study | NOT COMPLETED | XL184 (Cabozantinib) | 121 | |
| Overall Study | NOT COMPLETED | Placebo | 96 |
Source ClinicalTrials.gov
Adverse events468
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 | XL184 (Cabozantinib) | 14 | 214 | 14 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 10 | 109 | 10 |
| other | Leukopenia | Blood and lymphatic system disorders | XL184 (Cabozantinib) | 11 | 214 | 11 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo | 2 | 109 | 2 |
| other | Hypothyroidism | Endocrine disorders | XL184 (Cabozantinib) | 20 | 214 | 20 |
| other | Hypothyroidism | Endocrine disorders | Placebo | 1 | 109 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | XL184 (Cabozantinib) | 34 | 214 | 34 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 7 | 109 | 7 |
| other | Abdominal pain upper | Gastrointestinal disorders | XL184 (Cabozantinib) | 16 | 214 | 16 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 6 | 109 | 6 |
1 to 10 of 468Source ClinicalTrials.gov
See all 468 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | XL184 (Cabozantinib) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | XL184 (Cabozantinib) | 213 | 214 |
| Total, other adverse events | Placebo | 102 | 109 |
| Total, serious adverse events | XL184 (Cabozantinib) | 90 | 214 |
| Total, serious adverse events | Placebo | 25 | 109 |
Source ClinicalTrials.gov
Papers2
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| XL184 (Cabozantinib) vs Placebo: 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/NCT00704730
GET https://conductscience.org/api/trials/v1/NCT00704730/events?page=2