Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as XL184
Cabozantinib · 2 trials · 2 indications
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.
ORR was defined as the percentage of participants whose best overall response was complete response (CR) or partial response (PR) evaluated by the independent review committee (IRC) per response evaluation criteria in solid tumors version 1.1 (RECIST V1.1) which was confirmed by a subsequent evaluation conducted ≥28 days later. Per RECIST V1.1, CR was defined as the disappearance of all lesions, and all pathological lymph nodes (whether target or nontarget) must have a reduction in short axis to \<10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameter (SoD) of target lesions, taking as a reference the Baseline SoD.
| 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. |
| Cabozantinib 60 mg | EXPERIMENTAL | Cabozantinib 60 mg, tablet, orally, once daily (QD) in the fasted state until unacceptable toxicity or need for subsequent systemic anticancer treatment up to 2.5 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...
Cabozantinib is being studied for the treatment of advanced hepatocellular carcinoma and advanced renal cell carcinoma. It is an oral small molecule developed by Takeda Pharmaceutical Company Limited. The clinical program has focused on Japanese participants with these advanced solid tumors.
Cabozantinib targets MET and KDR. It is a small molecule inhibitor of these targets, which are receptor tyrosine kinases involved in tumor growth, angiogenesis, and metastatic spread. Inhibiting MET and KDR is intended to disrupt signaling pathways that support cancer progression.
Cabozantinib is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical studies evaluating cabozantinib in advanced hepatocellular carcinoma and advanced renal cell carcinoma.
Cabozantinib is in Phase 2 clinical development for advanced hepatocellular carcinoma and advanced renal cell carcinoma. It is an investigational agent and has not been approved for these indications based on the studies described here.
Cabozantinib has been evaluated in two completed Phase 2 trials. NCT03586973 studied cabozantinib in Japanese participants with advanced hepatocellular carcinoma, enrolling 34 patients. NCT03339219 studied cabozantinib in Japanese participants with advanced renal cell carcinoma, enrolling 35 patients. Both trials were conducted in Japan.