TriangleNCT00704730 · STUDY IN CONTEXT
Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer
Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
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.
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.
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
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.
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer-thyrogen-7158b9ac
- nct id
- NCT00704730
- trial label
- Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer
- applicability
- unclear
- applicability note
- Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer-thyrogen-7158b9ac
- nct id
- NCT00704730
- outcome key
- om-0000
- source section id
- NCT00704730-om-0000
- source outcome index
- 0
- endpoint
- Progression-Free Survival (PFS)
- endpoint definition
- 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.
- time origin
- 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.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent to Treat (ITT) 330 subjects were randomized and were included in the analysis. A Kaplan-Meyer analysis was performed to estimate the median.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer-thyrogen-7158b9ac
- nct id
- NCT00704730
- outcome key
- om-0001
- source section id
- NCT00704730-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival (OS) With XL184 Compared With Placebo
- endpoint definition
- 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.
- time origin
- 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.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent to treat (ITT) randomized to either XL184 or placebo
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer-thyrogen-7158b9ac
- nct id
- NCT00704730
- outcome key
- om-0002
- source section id
- NCT00704730-om-0002
- source outcome index
- 2
- endpoint
- Objective Response Rate (ORR)
- endpoint definition
- 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
- time origin
- 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.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer-thyrogen-7158b9ac
- nct id
- NCT00704730
- outcome key
- om-0003
- source section id
- NCT00704730-om-0003
- source outcome index
- 3
- endpoint
- Duration of Objective Response (OR): Independent Radiology Committee (IRC) Determined
- endpoint definition
- 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.
- time origin
- 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.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer-thyrogen-7158b9ac
- nct id
- NCT00704730
- outcome key
- om-0004
- source section id
- NCT00704730-om-0004
- source outcome index
- 4
- endpoint
- Biochemical Response Calcitonin (CTN) %
- endpoint definition
- 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.
- time origin
- 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.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer-thyrogen-7158b9ac
- nct id
- NCT00704730
- outcome key
- om-0005
- source section id
- NCT00704730-om-0005
- source outcome index
- 5
- endpoint
- Biochemical Response Carcinoembryonic Antigen (CEA) %
- endpoint definition
- 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.
- time origin
- 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.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer-thyrogen-7158b9ac
- nct id
- NCT00704730
- outcome key
- om-0000
- arm key
- OG000
- arm label
- XL184 (Cabozantinib)
- regimen
- XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily.
- analyzed count
- 219
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00704730-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer-thyrogen-7158b9ac
- nct id
- NCT00704730
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Placebo
- regimen
- Oral capsules once daily
- analyzed count
- 111
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00704730-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer-thyrogen-7158b9ac
- nct id
- NCT00704730
- outcome key
- om-0001
- arm key
- OG000
- arm label
- XL184 (Cabozantinib)
- regimen
- XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
- analyzed count
- 219
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00704730-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer-thyrogen-7158b9ac
- nct id
- NCT00704730
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Placebo
- regimen
- Oral capsules once daily
- analyzed count
- 111
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00704730-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer-thyrogen-7158b9ac
- nct id
- NCT00704730
- outcome key
- om-0002
- arm key
- OG000
- arm label
- XL184 (Cabozantinib)
- regimen
- XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
- analyzed count
- 208
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00704730-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer-thyrogen-7158b9ac
- nct id
- NCT00704730
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Placebo
- regimen
- Oral capsules once daily
- analyzed count
- 104
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00704730-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer-thyrogen-7158b9ac
- nct id
- NCT00704730
- outcome key
- om-0003
- arm key
- OG000
- arm label
- XL184 (Cabozantinib)
- regimen
- XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
- analyzed count
- 58
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00704730-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer-thyrogen-7158b9ac
- nct id
- NCT00704730
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Placebo
- regimen
- Oral capsules once daily
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00704730-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer-thyrogen-7158b9ac
- nct id
- NCT00704730
- outcome key
- om-0004
- arm key
- OG000
- arm label
- XL184 (Cabozantinib)
- regimen
- XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
- analyzed count
- 217
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00704730-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer-thyrogen-7158b9ac
- nct id
- NCT00704730
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Placebo
- regimen
- Oral capsules once daily
- analyzed count
- 110
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00704730-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer-thyrogen-7158b9ac
- nct id
- NCT00704730
- outcome key
- om-0005
- arm key
- OG000
- arm label
- XL184 (Cabozantinib)
- regimen
- XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
- analyzed count
- 218
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00704730-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer-thyrogen-7158b9ac
- nct id
- NCT00704730
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Placebo
- regimen
- Oral capsules once daily
- analyzed count
- 111
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00704730-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer-thyrogen-7158b9ac
- nct id
- NCT00704730
- harm key
- EG000
- source section id
- NCT00704730-ae
- event group key
- EG000
- event group label
- XL184 (Cabozantinib)
- serious affected
- 90
- serious at risk
- 214
- other affected
- 213
- other at risk
- 214
- frequency threshold
- 5
- collection period
- From baseline at regular intervals through to the date of the primary analysis
- event definition
- The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer-thyrogen-7158b9ac
- nct id
- NCT00704730
- harm key
- EG001
- source section id
- NCT00704730-ae
- event group key
- EG001
- event group label
- Placebo
- serious affected
- 25
- serious at risk
- 109
- other affected
- 102
- other at risk
- 109
- frequency threshold
- 5
- collection period
- From baseline at regular intervals through to the date of the primary analysis
- event definition
- The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice