Trial Outcomes & Findings for A Phase II Study of Cabozantinib (XL184) Therapy in Castrate Resistant Prostate Cancer (CRPC) With Visceral Metastases (NCT NCT01834651)

Last Updated: 2017-09-27

Results Overview

Clinical benefit rate is defined as the combination of complete response, partial response, and stable disease as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by CT imaging and Prostate Cancer Working Group 2 (PCWG2) criteria. Complete response (CR) defined as disappearance of all target lesions; Partial response (PR) \>=30% decrease in som of diameters of target lesions (taking as reference the baseline), and stable disease, neither sufficient shrinkage to qualify for PR nor increase to qualify for progressive disease.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

Baseline to 12 weeks after starting therapy

Results posted on

2017-09-27

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Cabozantinib) Cabozantinib 60mg orally daily until disease progression Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression.
Overall Study STARTED	17
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase II Study of Cabozantinib (XL184) Therapy in Castrate Resistant Prostate Cancer (CRPC) With Visceral Metastases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Cabozantinib) n=17 Participants Cabozantinib 60mg orally daily until disease progression Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression.
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks after starting therapy

Outcome measures

Outcome measures
Measure	Treatment (Cabozantinib) n=16 Participants Cabozantinib 60mg orally daily until disease progression Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression.	Treatment (Cabozantinib) VEGF Levels Carbozantinib 60mg
Clinical Benefit Rate From Cabozantinib (XL184)	10 Participants	—

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Change in number of CTC from baseline at 12 weeks

Outcome measures

Outcome measures
Measure	Treatment (Cabozantinib) n=14 Participants Cabozantinib 60mg orally daily until disease progression Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression.	Treatment (Cabozantinib) VEGF Levels Carbozantinib 60mg
Change in Number of Circulating Tumor Cells (CTC) in Response to Cabozantinib	53.2 CTCs/7.5 ml Standard Deviation 217.8	—

SECONDARY outcome

Timeframe: 12 weeks

Population: There were 16 patients evaluable for this outcome (1 patient did not have RECIST measurable disease)

This is to provide a measure of feasibility using NanoVelcro to measure RNA in circulating tumor cells (CTC)

Outcome measures

Outcome measures
Measure	Treatment (Cabozantinib) n=16 Participants Cabozantinib 60mg orally daily until disease progression Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression.	Treatment (Cabozantinib) VEGF Levels Carbozantinib 60mg
Number of Patients With NanoVelcro Appropriate for RNA in Circulating Tumor Cells	16 Participants	—

SECONDARY outcome

Timeframe: 12 weeks

Population: HGF was evaluable in 16 patients who had viable research samples. VEGF was evaluable in 15 patients who had viable research samples.

Mean change from baseline in levels of HGF and VEGF

Outcome measures

Outcome measures
Measure	Treatment (Cabozantinib) n=16 Participants Cabozantinib 60mg orally daily until disease progression Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression.	Treatment (Cabozantinib) VEGF Levels n=15 Participants Carbozantinib 60mg
Change in Levels of Serum Hepatocyte Growth Factor (HGF) and Vascular Endothelial Growth Factor (VEGF) Concentration	-322.96 pg/ml Standard Deviation 1981.19	191.1 pg/ml Standard Deviation 302.1

SECONDARY outcome

Timeframe: Every 2 weeks for first 3 Cycles and every 4 weeks thereafter for an expected average of 28 weeks.

Population: All patients

Each cycle is 28 days. Safety and tolerability was defined as related grade 3-4 AEs of doses of cabozantinib below 100 mg daily using common terminology criteria for adverse events (CTCAE)

Outcome measures

Outcome measures
Measure	Treatment (Cabozantinib) n=17 Participants Cabozantinib 60mg orally daily until disease progression Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression.	Treatment (Cabozantinib) VEGF Levels Carbozantinib 60mg
Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4) Lymphocyte count decreased	3 Participants	—
Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4) AST increased	4 Participants	—
Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4) Alkaline phosphatase increased	2 Participants	—
Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4) Anemia	1 Participants	—
Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4) Corneal Epithelial Defect	1 Participants	—
Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4) Dehydration	1 Participants	—
Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4) Diarrhea	1 Participants	—
Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4) GGT increased	1 Participants	—
Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4) Hematuria	1 Participants	—
Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4) Hypertension	1 Participants	—
Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4) Hyponatremia	2 Participants	—
Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4) Lipase increased	2 Participants	—
Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4) Palmar-Plantar Erythrodysesthesia	1 Participants	—
Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4) Rectal Fistula	1 Participants	—

SECONDARY outcome

Timeframe: From baseline until the date of first documented progression or date of death from any cause, whichever comes first, assessed for an expected average of 28 weeks.

Population: Only 12 samples were analyzed.

This is a feasibility outcome to assess ability to measure protein content in large oncosomes in this population.

Outcome measures

Outcome measures
Measure	Treatment (Cabozantinib) n=12 Participants Cabozantinib 60mg orally daily until disease progression Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression.	Treatment (Cabozantinib) VEGF Levels Carbozantinib 60mg
Number of Patients With Evaluable Protein Content of Large Oncosomes From Baseline to First Documented Progression or Date of Death	12 Participants	—

Adverse Events

Treatment (Cabozantinib)

Serious events: 14 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Cabozantinib) n=17 participants at risk Cabozantinib 60mg orally daily until disease progression Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression.
Blood and lymphatic system disorders Anemia	17.6% 3/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Cardiac disorders Chest Pain- Cardiac	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Hepatobiliary disorders Cholecystitis	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Psychiatric disorders Confusion	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Respiratory, thoracic and mediastinal disorders Dyspnea	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
General disorders Fever	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Renal and urinary disorders Hematuria	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Eye disorders Keratitis	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Gastrointestinal disorders Nausea	11.8% 2/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Gastrointestinal disorders Rectal fistula	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Eye disorders Retinal detachment	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE

Other adverse events

Other adverse events
Measure	Treatment (Cabozantinib) n=17 participants at risk Cabozantinib 60mg orally daily until disease progression Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression.
Eye disorders Cataract	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Gastrointestinal disorders Constipation	29.4% 5/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Investigations ALT increased	100.0% 17/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Investigations AST increased	88.2% 15/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Gastrointestinal disorders Abdominal pain	23.5% 4/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Investigations Activated PTT prolonged	11.8% 2/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Investigations Alkaline Phosphatase increased	64.7% 11/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Immune system disorders Allergic Reaction	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Immune system disorders Allergic Rhinitis	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Skin and subcutaneous tissue disorders Alopecia	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Skin and subcutaneous tissue disorders Anasarca	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Blood and lymphatic system disorders Anemia	47.1% 8/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Metabolism and nutrition disorders Anorexia	52.9% 9/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Psychiatric disorders Anxiety	11.8% 2/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Gastrointestinal disorders Ascites	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Musculoskeletal and connective tissue disorders Back pain	23.5% 4/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Reproductive system and breast disorders Bacterial Overgrowth	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Eye disorders Blepharitis	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Gastrointestinal disorders Bloating	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Investigations Blood Bilirubin Increased	23.5% 4/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Eye disorders Blurred Vision	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Musculoskeletal and connective tissue disorders Bone pain	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Injury, poisoning and procedural complications Bruising	11.8% 2/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Eye disorders Corneal Epithelial Defect	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Respiratory, thoracic and mediastinal disorders Cough	11.8% 2/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Investigations Creatinine Increased	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Metabolism and nutrition disorders Dehydration	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Gastrointestinal disorders Diarrhea	58.8% 10/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Eye disorders Diplopia	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Nervous system disorders Dizziness	11.8% 2/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Eye disorders Dry eye	17.6% 3/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Gastrointestinal disorders Dry mouth	23.5% 4/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Skin and subcutaneous tissue disorders Dry nose	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Nervous system disorders Dysguesia	17.6% 3/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Gastrointestinal disorders Dyspepsia	11.8% 2/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Respiratory, thoracic and mediastinal disorders Dyspnea	11.8% 2/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
General disorders Edema limbs	23.5% 4/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Respiratory, thoracic and mediastinal disorders Epistaxis	11.8% 2/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Eye disorders Inflamed eyelids	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Eye disorders Eye Pain	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Skin and subcutaneous tissue disorders Facial Rash	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
General disorders Fatigue	52.9% 9/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Gastrointestinal disorders Fecal Incontinence	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
General disorders Fever	23.5% 4/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Gastrointestinal disorders Flatulence	11.8% 2/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Gastrointestinal disorders Gastroesophageal Reflux Disease	23.5% 4/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Investigations GGT Increased	58.8% 10/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Reproductive system and breast disorders Genital Edema	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Reproductive system and breast disorders Gynecomastia	11.8% 2/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Skin and subcutaneous tissue disorders Hair Color Change	17.6% 3/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Renal and urinary disorders Hematuria	11.8% 2/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Gastrointestinal disorders Hemorrhoids	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Respiratory, thoracic and mediastinal disorders Hoarseness	58.8% 10/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
General disorders Hot Cold	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
General disorders Hot Flashes	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Metabolism and nutrition disorders Hyperkalemia	23.5% 4/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Metabolism and nutrition disorders Hypernatremia	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Vascular disorders Hypertension	23.5% 4/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Metabolism and nutrition disorders Hypoalbuminemia	58.8% 10/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Metabolism and nutrition disorders Hypocalcemia	23.5% 4/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Metabolism and nutrition disorders Hypoglycemia	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Metabolism and nutrition disorders Hypokalemia	23.5% 4/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Metabolism and nutrition disorders Hypomagnesemia	29.4% 5/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Metabolism and nutrition disorders Hyponatremia	58.8% 10/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Metabolism and nutrition disorders Hypophosphatemia	17.6% 3/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Vascular disorders Hypotension	11.8% 2/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Metabolism and nutrition disorders Hypothyroidism	17.6% 3/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Psychiatric disorders Insomnia	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Eye disorders Keratitis	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Investigations Lipase Increased	17.6% 3/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
General disorders Localized edema - bilateral leg	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Blood and lymphatic system disorders Lymphocyte Count Decreased	64.7% 11/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Gastrointestinal disorders Mucositis Oral	41.2% 7/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Musculoskeletal and connective tissue disorders Myalgia	17.6% 3/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Skin and subcutaneous tissue disorders Nail Changes	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Respiratory, thoracic and mediastinal disorders Nasal Discharge	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Gastrointestinal disorders Nausea	52.9% 9/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Musculoskeletal and connective tissue disorders Neck Pain	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Nervous system disorders Nervous system disorders other, T5 - T9 co	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Investigations Neutrophil Count Decreased	17.6% 3/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Nervous system disorders Oculomotor Nerve Disorder (3rd Nervepalsy)	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Musculoskeletal and connective tissue disorders Osteonecrosis of Jaw	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
General disorders Pain	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
General disorders Pain (Pain in Jaw)	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Musculoskeletal and connective tissue disorders Pain in Extremity	17.6% 3/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodysesthesia Syndrome	76.5% 13/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Nervous system disorders Paresthesia	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Infections and infestations Paronychia	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Investigations Platelet Count Decreased	47.1% 8/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Respiratory, thoracic and mediastinal disorders Pleural Effusion	11.8% 2/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Nervous system disorders Presyncope	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Psychiatric disorders Psychiatric disorders - Other, Nightmares	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Skin and subcutaneous tissue disorders Rash	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Skin and subcutaneous tissue disorders Rash maculo-papular	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Gastrointestinal disorders Rectal Fistula	11.8% 2/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Musculoskeletal and connective tissue disorders Right Foot Drop	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Skin and subcutaneous tissue disorders Scalp Follicullitos	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Investigations Serum Amylase Increased	17.6% 3/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Cardiac disorders Sinus Tachycardia	11.8% 2/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Skin and subcutaneous tissue disorders Skin Friable	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Skin and subcutaneous tissue disorders Skin Induration	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Skin and subcutaneous tissue disorders Skin discoloration	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Psychiatric disorders Somnolence	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Gastrointestinal disorders Stool Color Change	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Gastrointestinal disorders Surgical and medical procedures- Herniorrhaphy	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Nervous system disorders TMJ	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Cardiac disorders Tachycardia	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Infections and infestations Urinary Tract Infection	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Renal and urinary disorders Urinary Tract Obstruction	11.8% 2/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Eye disorders Vision Change	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Respiratory, thoracic and mediastinal disorders Voice Alteration	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Gastrointestinal disorders Vomiting (Intermittent)	17.6% 3/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Eye disorders Watering Eyes	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
General disorders Weakness	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Investigations Weight Loss	29.4% 5/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Respiratory, thoracic and mediastinal disorders Wheezing	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Investigations White Blood Cell Decreased	64.7% 11/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Metabolism and nutrition disorders hyperglycemia	5.9% 1/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE
Metabolism and nutrition disorders proteinuria	52.9% 9/17 • From signed consent up to 30 days after last treatment Attributions and ratings completed by Investigators as per CTCAE

Additional Information

Dr. Edwin Posadas

Cedars-Sinai Medical Center

Phone: 310-423-7600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place