Trial Outcomes & Findings for A Phase 2 Study of Cabozantinib in Japanese Participants With Advanced Renal Cell Carcinoma (NCT NCT03339219)
NCT ID: NCT03339219
Last Updated: 2021-09-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
From first dose of study drug up to first documentation of CR or PR (up to 2.5 years)
Results posted on
2021-09-20
Participant Flow
Participants took part in the study at 16 investigative sites in Japan from 13 December 2017 to 25 August 2020.
Participants with a diagnosis of advanced renal cell carcinoma (RCC) were enrolled in a single-arm study to receive cabozantinib 60 mg, tablet, orally, once daily.
Participant milestones
| Measure |
Cabozantinib 60 mg
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.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
35
|
Reasons for withdrawal
| Measure |
Cabozantinib 60 mg
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.
|
|---|---|
|
Overall Study
Death
|
12
|
|
Overall Study
Site Terminated by Sponsor
|
22
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cabozantinib 60 mg
n=35 Participants
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.
|
|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 9.81 • n=35 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=35 Participants
|
|
Region of Enrollment
Japan
|
35 Participants
n=35 Participants
|
|
Memorial Sloan-Kettering Cancer Center (MSKCC) Risk Factors
Favorable Risk (0)
|
11 Participants
n=35 Participants
|
|
Memorial Sloan-Kettering Cancer Center (MSKCC) Risk Factors
Intermediate Risk (1)
|
19 Participants
n=35 Participants
|
|
Memorial Sloan-Kettering Cancer Center (MSKCC) Risk Factors
Poor Risk (2 or 3)
|
5 Participants
n=35 Participants
|
|
Heng Criteria
Favorable Risk (0)
|
6 Participants
n=35 Participants
|
|
Heng Criteria
Intermediate Risk (1-2)
|
22 Participants
n=35 Participants
|
|
Heng Criteria
Poor Risk (3-6)
|
7 Participants
n=35 Participants
|
|
Karnofsky Performance Status (PS)
70 (Cares for self, unable to carry on normal activity or to do active work)
|
1 Participants
n=35 Participants
|
|
Karnofsky Performance Status (PS)
80 (Normal activity with effort; some signs or symptoms of disease)
|
5 Participants
n=35 Participants
|
|
Karnofsky Performance Status (PS)
90 (Able to carry on normal activity; minor signs or symptoms of disease)
|
5 Participants
n=35 Participants
|
|
Karnofsky Performance Status (PS)
100 (Normal, no complaints, no evidence of disease)
|
24 Participants
n=35 Participants
|
|
Eastern Cooperative Oncology (ECOG) Group PS
Grade 0
|
26 Participants
n=35 Participants
|
|
Eastern Cooperative Oncology (ECOG) Group PS
Grade 1
|
9 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to first documentation of CR or PR (up to 2.5 years)Population: FAS included all participants who received at least one dose of study drug.
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.
Outcome measures
| Measure |
Cabozantinib 60 mg
n=35 Participants
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.
|
|---|---|
|
Objective Response Rate (ORR)
|
25.7 percentage of participants
Interval 14.122 to 40.582
|
SECONDARY outcome
Timeframe: From first dose of study drug up to first documentation of CR or PR or SD (up to 2.5 years)Population: FAS included all participants who received at least one dose of study drug.
CBR was defined as percentage of participants whose best overall response is CR, PR, or stable disease (SD) per RECIST V1.1. Response and progression were evaluated by IRC per RECIST V1.1. CR and PR required confirmation by a subsequent evaluation conducted ≥28 days later and an assessment of SD was made at least 8 weeks after the first day of study drug. 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 the short axis to \<10 mm. PR was defined as at least a 30% decrease in SoD of target lesions, taking as a reference the Baseline SoD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
Cabozantinib 60 mg
n=35 Participants
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.
|
|---|---|
|
Clinical Benefit Rate (CBR)
|
85.7 percentage of participants
Interval 69.743 to 95.194
|
SECONDARY outcome
Timeframe: From first dose of study drug up to disease progression or death (up to 2.5 years)Population: FAS included all participants who received at least one dose of study drug.
PFS was defined as the time from the first day of study drug administration to the earlier of progressive disease (PD) per RECIST V1.1 or death due to any cause. Per RECIST V1.1, PD was defined at least a 20% increase in the SoD of target lesions, taking as a reference the smallest (nadir) SoD since (and including) Baseline. In addition to the relative increase of 20%, the SoD also demonstrated an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Cabozantinib 60 mg
n=35 Participants
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.
|
|---|---|
|
Progression-Free Survival (PFS)
|
11.1 months
Interval 7.4 to 18.4
|
SECONDARY outcome
Timeframe: From first dose of study drug up to death due to any cause (up to 2.5 years)Population: FAS included all participants who received at least one dose of study drug.
OS is defined as the time from the first day of study drug administration to death due to any cause.
Outcome measures
| Measure |
Cabozantinib 60 mg
n=35 Participants
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.
|
|---|---|
|
Overall Survival (OS)
|
NA months
Interval 23.4 to
Median and upper limit for 95% confidence interval (CI) was not estimable due to the low number of participants with events.
|
SECONDARY outcome
Timeframe: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)Population: Safety Analysis Set included all participants who received at least one dose of study drug.
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as AEs whose date of onset occurs on or after the start of study drug and within 30 days after the last dose of study treatment.
Outcome measures
| Measure |
Cabozantinib 60 mg
n=35 Participants
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.
|
|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)Population: Safety Analysis Set included all participants who received at least one dose of study drug.
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as AEs whose date of onset occurs on or after the start of study drug and within 30 days after the last dose of study treatment. Severity grade was defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. As per the NCI-CTCAE, Grade 1 scales as mild; Grade 2 scales as moderate; Grade 3 scales as severe or medically significant but not immediately life-threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.
Outcome measures
| Measure |
Cabozantinib 60 mg
n=35 Participants
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.
|
|---|---|
|
Percentage of Participants With Grade 3 or Higher TEAEs
|
82.9 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)Population: Safety Analysis Set included all participants who received at least one dose of study drug.
A serious TEAE was any untoward medical occurrence or effect that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically important due to other reasons than the above-mentioned criteria. TEAEs were defined as AEs whose date of onset occurs on or after the start of study drug and within 30 days after the last dose of study treatment.
Outcome measures
| Measure |
Cabozantinib 60 mg
n=35 Participants
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.
|
|---|---|
|
Percentage of Participants With Serious TEAEs
|
42.9 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)Population: Safety Analysis Set included all participants who received at least one dose of study drug.
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as AEs whose date of onset occurs on or after the start of study drug and within 30 days after the last dose of study treatment.
Outcome measures
| Measure |
Cabozantinib 60 mg
n=35 Participants
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.
|
|---|---|
|
Percentage of Participants With TEAEs Leading to Permanent Treatment Discontinuation
|
17.1 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)Population: Safety Analysis Set included all participants who received at least one dose of study drug.
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as AEs whose date of onset occurs on or after the start of study drug and within 30 days after the last dose of study treatment.
Outcome measures
| Measure |
Cabozantinib 60 mg
n=35 Participants
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.
|
|---|---|
|
Percentage of Participants With TEAEs Leading to Dose Modification (Dose Reduction or Interruption)
Dose Reduction
|
88.6 percentage of participants
|
|
Percentage of Participants With TEAEs Leading to Dose Modification (Dose Reduction or Interruption)
Dose Interruption
|
80.0 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)Population: Safety Analysis Set included all participants who received at least one dose of study drug.
Clinical laboratory tests included tests of serum chemistry, hematology, urine chemistry, coagulation, and thyroid function prespecified in the protocol. Only those categories are reported which are considered clinically significant abnormal laboratory values post baseline, as assessed by the investigator.
Outcome measures
| Measure |
Cabozantinib 60 mg
n=35 Participants
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.
|
|---|---|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
White Blood Cells (WBC) Decreased
|
17.1 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Absolute Neutrophil Count (ANC) Decreased
|
5.7 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Lymphocytes Increased
|
2.9 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Lymphocytes Decreased
|
34.3 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Platelets Decreased
|
20.0 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Hemoglobin Increased
|
2.9 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Hemoglobin Decreased
|
85.7 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Albumin Decreased
|
88.6 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Alkaline Phosphatase (ALP) Increased
|
65.7 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Amylase Increased
|
57.1 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Alkaline Phosphatase (ALT) Increased
|
74.3 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Aspartate Aminotransferase (AST) Increased
|
80.0 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Corrected Calcium Increased
|
5.7 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Corrected Calcium Decreased
|
8.6 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Creatinine Increased
|
97.1 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Gamma-glutamyl Transferase (GGT) Increased
|
54.3 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Glucose Increased
|
62.9 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Glucose Decreased
|
5.7 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Lactate Dehydrogenase (LDH) Increased
|
100 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Lipase Increased
|
45.7 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Magnesium Increased
|
14.3 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Magnesium Decreased
|
77.1 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Phosphate Decreased
|
54.3 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Potassium Increased
|
14.3 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Potassium Decreased
|
22.9 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Sodium Decreased
|
48.6 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Total Bilirubin Increased
|
17.1 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Urine Protein-to-creatinine Ratio (UPCR) Increased
|
91.4 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)Population: Safety Analysis Set included all participants who received at least one dose of study drug. Number analyzed are the number of participants with data available for analyses in the given category.
Vital signs included diastolic blood pressure (DBP) and systolic blood pressure (SBP) in the sitting position, pulse rate respiratory rate temperature, and weight. Abnormal vital sign values considered by the investigator to be clinically significant are reported as categories.
Outcome measures
| Measure |
Cabozantinib 60 mg
n=35 Participants
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.
|
|---|---|
|
Percentage of Participants With Clinically Significant Abnormal Vital Sign
BP Increased: SBP <120 millimeters of mercury (mmHg) and DBP <80 mmHg
|
2.9 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Vital Sign
BP Increased: SBP 120<= - <=139 mmHg or DBP 80<= - <=89 mmHg
|
11.8 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Vital Sign
BP Increased: SBP 140<= - <=159 mmHg or DBP 90<= - <=99 mmHg
|
64.7 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Vital Sign
BP Increased: SBP 160 mmHg<= and DBP <120 mmHg, or DBP 100<=- <=119 mmHg
|
20.6 percentage of participants
|
|
Percentage of Participants With Clinically Significant Abnormal Vital Sign
Weight Decreased >=10% from Baseline
|
37.1 percentage of participants
|
Adverse Events
Cabozantinib 60 mg
Serious events: 15 serious events
Other events: 35 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Cabozantinib 60 mg
n=35 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Ileus
|
2.9%
1/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
2.9%
1/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Lung infection
|
2.9%
1/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Amylase increased
|
2.9%
1/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Lipase increased
|
2.9%
1/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Pancreatic enzymes increased
|
2.9%
1/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.9%
1/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.9%
1/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.9%
1/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.9%
1/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
2.9%
1/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
2.9%
1/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Brain oedema
|
2.9%
1/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Spinal cord disorder
|
2.9%
1/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.9%
1/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Cabozantinib 60 mg
n=35 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
17.1%
6/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
17.1%
6/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Cataract
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
68.6%
24/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
42.9%
15/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
10/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
7/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
17.1%
6/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dental caries
|
11.4%
4/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Periodontal disease
|
11.4%
4/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Toothache
|
8.6%
3/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Malaise
|
31.4%
11/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pyrexia
|
22.9%
8/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
17.1%
6/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Oedema peripheral
|
8.6%
3/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
37.1%
13/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Immune system disorders
Contrast media allergy
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
22.9%
8/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gingivitis
|
11.4%
4/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Periodontitis
|
8.6%
3/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Angular cheilitis
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Oral candidiasis
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Oral herpes
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Skin infection
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
8.6%
3/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Weight decreased
|
40.0%
14/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
25.7%
9/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
7/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
14.3%
5/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Amylase increased
|
11.4%
4/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
11.4%
4/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
8.6%
3/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Neutrophil count decreased
|
8.6%
3/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Platelet count decreased
|
8.6%
3/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatinine increased
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood lactate dehydrogenase abnormal
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Lipase increased
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
31.4%
11/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.6%
3/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
28.6%
10/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.4%
4/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
17.1%
6/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dysgeusia
|
42.9%
15/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Insomnia
|
14.3%
5/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
48.6%
17/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
17.1%
6/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
5/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.4%
4/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.4%
4/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
65.7%
23/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
7/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
17.1%
6/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.6%
3/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.6%
3/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.6%
3/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.7%
2/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypertension
|
42.9%
15/35 • Up to 2.6 years
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER