Dose-Finding Study of Cabozantinib (XL184) in Japanese Subjects With Advanced Cancer
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|ClinicalTrials.gov Identifier: NCT01553656|
Recruitment Status : Completed
First Posted : March 14, 2012
Last Update Posted : August 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors Cancer NSCLC||Drug: cabozantinib capsules Drug: cabozantinib tablets||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||85 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Multiple Ascending Dose Study of XL184 Monotherapy in Japanese Subjects With Advanced or Metastatic Solid Tumors|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||July 2015|
Experimental: Cabozantinib capsules and tablets
Subjects will be enrolled in cohorts at different dose levels in order to determine the maximum tolerated dose of cabozantinib. Initially, subjects enrolled will receive the capsule formulation; other subjects will receive the tablet formulation.
Drug: cabozantinib capsules
cabozantinib capsules administered as 25-mg and 100-mg strengths once-daily until disease progression
Other Name: XL184
Drug: cabozantinib tablets
cabozantinib tablets administered as 20-mg and 60-mg strengths once-daily until disease progression
Other Name: XL184
- Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose [ Time Frame: Assessed in the clinic on Days 1 through 29 ]To establish the MTD and recommended Phase 2 dose (or dose range as appropriate) of XL184 when administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors.
- Safety and tolerability of XL184 [ Time Frame: From study start to October 2014 ]Safety and tolerability of multiple doses of XL184 administered orally on a daily basis. Assessed from informed consent until at least 30 days after discontinuation.
- Plasma Pharmacokinetics [ Time Frame: Assessed in the clinic from Day 1 through Day 29 ]Assess plasma pharmacokinetics of daily oral administration of XL184 from Treatment Day 1 to Day 29.
- Tumor response (preliminary anti-tumor activity) [ Time Frame: Study start to October 2014 ]Assess tumor response after repeated administration of XL184 from screening until discontinuation. Assessed as best overall response by cohort by radiological response defined by RECIST criteria.
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): NCT01553656
|The Cancer Institute Hospital of the Japanese Foundation for Cancer Research (JFCR)|
|Ariake, Koto, Japan, 135-8550|
|National Cancer Center Hospital|
|Chuo-ku, Tokyo, Japan, 104-0045|