NCT00940225Phase 2Completed

Study of Cabozantinib (XL184) in Adults With Advanced Malignancies

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Primary completion2013-05ACTUAL

Enrollment730ACTUAL

Source updated2024-04-25Values from available record

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Conditions: Solid Tumors; Cancer
Interventions: type: DRUG; name: Cabozantinib; otherNames: XL184; type: DRUG; name: Placebo
Primary outcomes: measure: Objective Response Rate (ORR) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort Only; description: 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.; timeFrame: From initial dose through final study visit up to 44 months; measure: Bone Scan Response (BSR) - NRE, CRPC; description: 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.; timeFrame: From initial dose through final study visit up to 15 months; measure: Progression-Free Survival (PFS) - Randomized Stage, RDT Cohorts Only; description: Progression Free Survival during the Randomized Stage (Randomized Population); timeFrame: From initial dose through final study visit up to 44 months
History coverage: Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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