Trial Outcomes & Findings for Cabozantinib S-Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer (NCT NCT01935934)

NCT ID: NCT01935934

Last Updated: 2025-10-01

Results Overview

Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

102 participants

Primary outcome timeframe

At 12 weeks, then every 8 weeks during treatment; up to 12 weeks post-treatment if discontinued due to toxicities, a maximum of 16 weeks

Results posted on

2025-10-01

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental (Endometriod + Serous) Patients receive cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Exploratory (Uncommon Histology) Patients receive cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Overall Study STARTED	70	32
Overall Study COMPLETED	70	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cabozantinib S-Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental (Endometriod + Serous) n=70 Participants Patients receive cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Exploratory (Uncommon Histology) n=32 Participants Patients receive cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Total n=102 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants	14 Participants n=7 Participants	47 Participants n=5 Participants
Age, Categorical >=65 years	37 Participants n=5 Participants	18 Participants n=7 Participants	55 Participants n=5 Participants
Age, Continuous	70 years n=5 Participants	66 years n=7 Participants	66 years n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	32 Participants n=7 Participants	102 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	67 Participants n=5 Participants	27 Participants n=7 Participants	94 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	54 Participants n=5 Participants	25 Participants n=7 Participants	79 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Canada	48 participants n=5 Participants	22 participants n=7 Participants	70 participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	10 participants n=7 Participants	32 participants n=5 Participants

PRIMARY outcome

Timeframe: At 12 weeks, then every 8 weeks during treatment; up to 12 weeks post-treatment if discontinued due to toxicities, a maximum of 16 weeks

Outcome measures

Outcome measures
Measure	Experimental (Endometriod + Serous) n=70 Participants Patients receive cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Exploratory (Uncommon Histology) n=32 Participants Patients receive cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Carcinosarcoma Patients receive 60 mg cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Other Histology Patients receive 60 mg cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Response Rate	9 Participants	2 Participants	—	—

PRIMARY outcome

Timeframe: Time from start of treatment to time of progression or death, assessed at 12 weeks

Defined as the percentage of patients progression free 12 weeks from starting treatment.

Outcome measures

Outcome measures
Measure	Experimental (Endometriod + Serous) n=70 Participants Patients receive cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Exploratory (Uncommon Histology) n=32 Participants Patients receive cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Carcinosarcoma Patients receive 60 mg cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Other Histology Patients receive 60 mg cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Progression-free Survival	67.17 percentage of participants	46.88 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Archival tumor was available in 91 patients. Genomic analysis failed in 7. Of the remaining 84, 83 tumors were profiled on the NGS TruSeq amplicon panel and 1 on Sequenom to analyze the number of mutations observed.

Will correlate with clinical response. 83 tumors were profiled on the NGS TruSeq amplicon panel and 1 on Sequenom. Fields with at least 50 tumor cells were captured to analyze 100 non-overlapping tumor cell nuclei to calculate a ratio of MET to CEP7 signal; MET ampliction was defined as MET/CEP7 ratio \>=2.

Outcome measures

Outcome measures
Measure	Experimental (Endometriod + Serous) n=31 Participants Patients receive cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Exploratory (Uncommon Histology) n=30 Participants Patients receive cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Carcinosarcoma n=15 Participants Patients receive 60 mg cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Other Histology n=8 Participants Patients receive 60 mg cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Number of Participants With Archival Specimens That Had C-met Amplification or Mutation PTEN	13 participants	NA participants Below level of detection	NA participants Below level of detection	NA participants Below level of detection
Number of Participants With Archival Specimens That Had C-met Amplification or Mutation PIK3CA	10 participants	10 participants	6 participants	NA participants Below level of detection
Number of Participants With Archival Specimens That Had C-met Amplification or Mutation CTNNB1	9 participants	NA participants Below level of detection	NA participants Below level of detection	NA participants Below level of detection
Number of Participants With Archival Specimens That Had C-met Amplification or Mutation KRAS	8 participants	3 participants	3 participants	NA participants Below level of detection
Number of Participants With Archival Specimens That Had C-met Amplification or Mutation TP53	6 participants	19 participants	7 participants	NA participants Below level of detection
Number of Participants With Archival Specimens That Had C-met Amplification or Mutation MET	0 participants	0 participants	0 participants	NA participants Below level of detection

SECONDARY outcome

Timeframe: Time from start of treatment to time of death, every 6 months

Population: Participants followed for overall survival, every 6 months until death

Will correlate with clinical response.

Outcome measures

Outcome measures
Measure	Experimental (Endometriod + Serous) n=6 Participants Patients receive cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Exploratory (Uncommon Histology) n=7 Participants Patients receive cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Carcinosarcoma Patients receive 60 mg cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	Other Histology Patients receive 60 mg cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Overall Survival	4 Participants	3 Participants	—	—

Adverse Events

Treatment (Cabozantinib S-malate)

Serious events: 42 serious events

Other events: 102 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Cabozantinib S-malate) n=102 participants at risk Patients receive cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Gastrointestinal disorders Gastric hemorrhage	2.0% 2/102 • Number of events 2 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Vascular disorders Thromboembolic event	3.9% 4/102 • Number of events 5 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Metabolism and nutrition disorders Hyponatremia	2.9% 3/102 • Number of events 4 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Metabolism and nutrition disorders Hypophosphatemia	2.0% 2/102 • Number of events 2 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Progressive disease	2.9% 3/102 • Number of events 3 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Cardiac disorders Sinus tachycardia	2.0% 2/102 • Number of events 2 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Metabolism and nutrition disorders Hypokalemia	2.9% 3/102 • Number of events 3 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.0% 2/102 • Number of events 3 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Respiratory, thoracic and mediastinal disorders Dyspnea	0.98% 1/102 • Number of events 2 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
General disorders Death	2.0% 2/102 • Number of events 2 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Gastrointestinal disorders Gastrointestinal fistula	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Gastrointestinal disorders Abdominal pain	2.9% 3/102 • Number of events 3 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Metabolism and nutrition disorders Anorexia	2.9% 3/102 • Number of events 3 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Metabolism and nutrition disorders Hypercalcemia	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Musculoskeletal and connective tissue disorders Back pain	2.0% 2/102 • Number of events 2 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Nervous system disorders Akathisia	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Nervous system disorders Cognitive disturbance	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Musculoskeletal and connective tissue disorders Flank pain	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Gastrointestinal disorders Diarrhea	3.9% 4/102 • Number of events 5 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
General disorders Fever	2.0% 2/102 • Number of events 2 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Gastrointestinal disorders Colonic perforation	3.9% 4/102 • Number of events 4 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Investigations Alanine aminotransferase increased	2.9% 3/102 • Number of events 3 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Vascular disorders Hypertension	5.9% 6/102 • Number of events 8 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Musculoskeletal and connective tissue disorders Pain in extremity	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Gastrointestinal disorders Colonic fistula	2.0% 2/102 • Number of events 2 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Gastrointestinal disorders Dental caries	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Gastrointestinal disorders Ileal perforation	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Infections and infestations Urinary tract infection	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Investigations Lipase increased	2.0% 2/102 • Number of events 2 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Vascular disorders Hypotension	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Infections and infestations Blood	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Blood and lymphatic system disorders Anemia	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Investigations Lymphocyte count decreased	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Investigations Weight loss	2.0% 2/102 • Number of events 2 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Gastrointestinal disorders Nausea	2.0% 2/102 • Number of events 2 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Renal and urinary disorders Hematuria	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Infections and infestations Skin infection	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Investigations Platelet count decreased	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Vascular disorders Lymphedema	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Nervous system disorders Syncope	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Infections and infestations Urosepsis	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Eye disorders Blurred vision	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
General disorders Fatigue	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Nervous system disorders Memory impairment	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Gastrointestinal disorders Dysphagia	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Hepatobiliary disorders Cholecystitis	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Investigations GGT increased	0.98% 1/102 • Number of events 2 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Infections and infestations Abdominal infection	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Gastrointestinal disorders Colonic obstruction	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Respiratory, thoracic and mediastinal disorders Pneumonia	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Nervous system disorders Confusion	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Investigations Alkaline phosphatase increased	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Investigations Aspartate aminotransferase increased	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Investigations Blood bilirubin increased	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Endocrine disorders Hypothyroidism	0.98% 1/102 • Number of events 1 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).

Other adverse events

Other adverse events
Measure	Treatment (Cabozantinib S-malate) n=102 participants at risk Patients receive cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cabozantinib S-malate: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
General disorders Fatigue	63.7% 65/102 • Number of events 65 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Metabolism and nutrition disorders Anorexia	48.0% 49/102 • Number of events 49 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Investigations Weight loss	30.4% 31/102 • Number of events 31 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Vascular disorders Hypertension	51.0% 52/102 • Number of events 52 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Gastrointestinal disorders Diarrhea	58.8% 60/102 • Number of events 60 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Gastrointestinal disorders Nausea	45.1% 46/102 • Number of events 46 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Gastrointestinal disorders Dysgeusia	41.2% 42/102 • Number of events 42 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Gastrointestinal disorders Mucositis	37.3% 38/102 • Number of events 38 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Gastrointestinal disorders Vomiting	18.6% 19/102 • Number of events 19 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Gastrointestinal disorders Gastrointestinal reflux	16.7% 17/102 • Number of events 17 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Gastrointestinal disorders Dyspepsia	12.7% 13/102 • Number of events 13 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Gastrointestinal disorders Dry mouth	14.7% 15/102 • Number of events 15 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Gastrointestinal disorders Abdominal pain	18.6% 19/102 • Number of events 19 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia	39.2% 40/102 • Number of events 40 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Skin and subcutaneous tissue disorders Dry skin	10.8% 11/102 • Number of events 11 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Skin and subcutaneous tissue disorders Pruritus	9.8% 10/102 • Number of events 10 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Skin and subcutaneous tissue disorders Alopecia	11.8% 12/102 • Number of events 12 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Blood and lymphatic system disorders Anemia	26.5% 27/102 • Number of events 27 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Investigations White blood cell decreased	32.4% 33/102 • Number of events 33 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Investigations Lymphocyte count decreased	30.4% 31/102 • Number of events 31 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Investigations Neutrophil count decreased	22.5% 23/102 • Number of events 23 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Investigations Platelet count decreased	19.6% 20/102 • Number of events 20 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Investigations Aspartate aminotransferase increased	64.7% 66/102 • Number of events 66 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Investigations Hypomagnesemia	47.1% 48/102 • Number of events 48 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Investigations Hypophosphatemia	29.4% 30/102 • Number of events 30 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Investigations Alkaline aminotransferase increased	23.5% 24/102 • Number of events 24 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Investigations Hypoalbuminemia	28.4% 29/102 • Number of events 29 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Investigations GGT increased	16.7% 17/102 • Number of events 17 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Investigations Hyponatremia	20.6% 21/102 • Number of events 21 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Investigations Hypokalemia	18.6% 19/102 • Number of events 19 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Investigations Blood bilirubin increased	11.8% 12/102 • Number of events 12 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Renal and urinary disorders Proteinuria	11.8% 12/102 • Number of events 12 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Endocrine disorders Endocrine disorder	11.8% 12/102 • Number of events 12 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Respiratory, thoracic and mediastinal disorders Hoarseness	14.7% 15/102 • Number of events 15 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Musculoskeletal and connective tissue disorders Pain in extremity	10.8% 11/102 • Number of events 11 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Nervous system disorders Headache	10.8% 11/102 • Number of events 11 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Vascular disorders Vascular disorder	11.8% 12/102 • Number of events 12 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Vascular disorders Venous thromboembolism	10.8% 11/102 • Number of events 11 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Gastrointestinal disorders Gastrointestinal disorder	7.8% 8/102 • Number of events 8 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).
Investigations Alanine aminotransferase increased	62.7% 64/102 • Number of events 64 • Through study completion, an average of 6 months with a maximum of up to 4 years. As pre-defined in the study protocol, adverse events were collected and analyzed for both cohorts together (combined data).

Additional Information

Dr. Neesha Dhani

University Health Network - Princess Margaret Cancer Centre

Phone: 416-946-4501

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60