Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03586973 | A Phase 2 Study of Cabozantinib in Japanese Participants With Advanced Hepatocellular Carcinoma | PHASE2 | COMPLETED | 34 | — | — | Aug 6, 2018 | Jun 29, 2021 | Apr 18, 2023 | 17 | Japan |
24-week PFSR=percentage of participants with progression-free survival (PFS) of at least 24 weeks at Week 25 Day 1 plus 7 days. PFS=time from first day of study drug administration to earlier of progressive disease (PD) or death due to any cause per Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST 1.1). PD=at least a 20% increase in sum of target lesion diameters (SoD) with reference to smallest(nadir) SoD. In addition to relative increase of 20%, SoD must also demonstrate an absolute increase of at least 5 mm. For nontarget lesion time Point Response, unequivocal progression of nontarget lesions. Modest 'increase' in size of one or more nontarget lesions is usually not sufficient to quality for unequivocal progression status, it must not be representative of single lesion increase. Lesion in an anatomical location and not scanned at baseline is considered new lesion. Lesion qualifies as PD if finding is unequivocally not due to change in imaging technique or modality.
| Arm | Type | Description |
|---|---|---|
| Cohort A: Cabozantinib 60 mg | EXPERIMENTAL | Participants who have received first/second line anticancer therapy with sorafenib were assigned to Cohort A and received cabozantinib 60 milligrams (mg), tablet, orally, once daily in the fasted state, up to approximately 2 years. |
| Cohort B: Cabozantinib 60 mg | EXPERIMENTAL | Participants who did not receive first/second line anticancer therapy with sorafenib were assigned to Cohort B and received cabozantinib 60 mg, tablet orally, once daily in the fasted state, up to approximately 2 years. |
| Name | Type | Description |
|---|---|---|
| Cabozantinib | DRUG | Cabozantinib tablet |
Inclusion Criteria: 1. Male or female Japanese participants 20 years of age or older on the day of consent. 2. Histological or cytological diagnosis of HCC (results of a previous biopsy will be accepted). 3. Measurable disease per response evaluation criteria in solid tumors (RECIST) 1.1 as determi...