A Study of Two Different Doses of Cabozantinib (XL184) in Progressive, Metastatic Medullary Thyroid Cancer (EXAMINER)
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|ClinicalTrials.gov Identifier: NCT01896479|
Recruitment Status : Active, not recruiting
First Posted : July 11, 2013
Last Update Posted : April 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Medullary Thyroid Cancer||Drug: Cabozantinib (XL184) 140 mg Drug: Cabozantinib (XL184) 60 mg Drug: Placebo tablet Drug: Placebo capsule||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind Study To Evaluate the Efficacy and Safety of Cabozantinib (XL184) at 60 mg/Day Compared to a 140 mg/Day in Progressive, Metastatic Medullary Thyroid Cancer Patients|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||December 2022|
Experimental: Cabozantinib (XL184) 140 mg
Cabozantinib (XL184) 140 mg as capsules and placebo tablets administered orally once a day.
Drug: Cabozantinib (XL184) 140 mg
Drug: Placebo tablet
Experimental: Cabozantinib (XL184) 60 mg
Cabozantinib (XL184) 60 mg as tablets and placebo capsules administered orally once a day.
Drug: Cabozantinib (XL184) 60 mg
Drug: Placebo capsule
- Progression Free Survival [ Time Frame: Up to 31 months ]PFS is measured from randomization until the date of first documented disease progression or date of death from any cause, whichever comes first. Assessed for up to 31 months.
- Objective Response Rate [ Time Frame: Up to 31 months ]ORR is the proportion of subjects with measurable disease at baseline and who experience a best overall response of complete response (CR) or partial response (PR) which is confirmed ≥ 28 days later. Assessed for up to 31 months.
- Safety and tolerability of cabozantinib as assessed by adverse events. [ Time Frame: Up to 31 months ]Adverse events are measured from informed consent and at least through 30 days after the date of a decision to discontinue study treatment. Assessed for up to 31 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896479