Trial Outcomes & Findings for Phase II Study of Axitinib (AG-013736) With Evaluation of the VEGF-pathway in Metastatic, Recurrent or Primary Unresectable Pheochromocytoma/Paraganglioma (NCT NCT01967576)

NCT ID: NCT01967576

Last Updated: 2021-01-06

Results Overview

Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or no-target) must have reduction in short axis to \<10 mm. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Patients were assessed every 12 weeks (+/- week) up to 40.6 months

Results posted on

2021-01-06

Participant Flow

Participant milestones

Participant milestones
Measure	1/Arm 1-Axitinib Axitinib 5 mg twice a day on a 28-day cycle Axitinib (AG-013736): 5 mg twice a day on a 28-day cycle.
Overall Study STARTED	14
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	1/Arm 1-Axitinib Axitinib 5 mg twice a day on a 28-day cycle Axitinib (AG-013736): 5 mg twice a day on a 28-day cycle.
Overall Study Withdrawal by Subject	3
Overall Study Progressed/Removed from treatment	1
Overall Study Study closing at site	1
Overall Study Adverse Event	1
Overall Study Refused further treatment	1

Baseline Characteristics

Phase II Study of Axitinib (AG-013736) With Evaluation of the VEGF-pathway in Metastatic, Recurrent or Primary Unresectable Pheochromocytoma/Paraganglioma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1/Arm 1-Axitinib n=14 Participants Axitinib 5 mg twice a day on a 28-day cycle Axitinib (AG-013736): 5 mg twice a day on a 28-day cycle.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	52.66 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	1 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Patients were assessed every 12 weeks (+/- week) up to 40.6 months

Population: 2/14 participants were not evaluated for this outcome measure. Current Investigator inherited this trial when the original investigator left the National Institutes of Health (NIH). The reason participants were not evaluated is unknown.

Outcome measures

Outcome measures
Measure	1/Arm 1-Axitinib n=12 Participants Axitinib 5 mg twice a day on a 28-day cycle Axitinib (AG-013736): 5 mg twice a day on a 28-day cycle.
Number of Participants With Clinical Response (Partial Response + Complete Response) Confirmed Partial Response	5 Participants
Number of Participants With Clinical Response (Partial Response + Complete Response) Complete Response	0 Participants
Number of Participants With Clinical Response (Partial Response + Complete Response) Stable Disease	5 Participants
Number of Participants With Clinical Response (Partial Response + Complete Response) Progressive Disease	2 Participants

SECONDARY outcome

Timeframe: time from start of treatment to time of progression or death, up to 5 years and 9 months

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).

Outcome measures

Outcome measures
Measure	1/Arm 1-Axitinib n=12 Participants Axitinib 5 mg twice a day on a 28-day cycle Axitinib (AG-013736): 5 mg twice a day on a 28-day cycle.
Progression - Free Survival (PFS)	7.7 months Interval 3.3 to 16.8

SECONDARY outcome

Timeframe: up to 3 years

Population: Blood samples were collected on a subset of participants, but assays were never performed on any of the samples and therefore no data for the Outcome Measures were collected.

The measurement of VEGFR in blood will be performed using a semi-quantitative immunohistochemistry assay.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 3 years

Population: Blood samples were collected on a subset of participants, but assays were never performed on any of the samples and therefore no data for the Outcome Measures were collected.

Measuring genetic alterations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 3 years

Population: Blood samples were collected on a subset of participants, but assays were never performed on any of the samples and therefore no data for the Outcome Measures were collected.

Pharmacokinetic analysis will be done to determine drug levels in blood.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, approximately 54 months and 29 days.

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	1/Arm 1-Axitinib n=14 Participants Axitinib 5 mg twice a day on a 28-day cycle Axitinib (AG-013736): 5 mg twice a day on a 28-day cycle.
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)	14 Participants

Adverse Events

1/Arm 1-Axitinib

Serious events: 2 serious events

Other events: 14 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	1/Arm 1-Axitinib n=14 participants at risk Axitinib 5 mg twice a day on a 28-day cycle Axitinib (AG-013736): 5 mg twice a day on a 28-day cycle.
Blood and lymphatic system disorders Anemia	14.3% 2/14 • Number of events 3 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Gastrointestinal disorders Duodenal hemorrhage	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
General disorders Edema limbs	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Vascular disorders Hypotension	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Cardiac disorders Sinus tachycardia	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.

Other adverse events

Other adverse events
Measure	1/Arm 1-Axitinib n=14 participants at risk Axitinib 5 mg twice a day on a 28-day cycle Axitinib (AG-013736): 5 mg twice a day on a 28-day cycle.
Gastrointestinal disorders Abdominal pain	42.9% 6/14 • Number of events 16 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Investigations Activated partial thromboplastin time prolonged	14.3% 2/14 • Number of events 4 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Renal and urinary disorders Acute kidney injury	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Investigations Alanine aminotransferase increased	35.7% 5/14 • Number of events 7 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Investigations Alkaline phosphatase increased	50.0% 7/14 • Number of events 11 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Immune system disorders Allergic reaction	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	21.4% 3/14 • Number of events 3 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Blood and lymphatic system disorders Anemia	71.4% 10/14 • Number of events 30 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Metabolism and nutrition disorders Anorexia	35.7% 5/14 • Number of events 10 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Psychiatric disorders Anxiety	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Musculoskeletal and connective tissue disorders Arthralgia	21.4% 3/14 • Number of events 5 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Investigations Aspartate aminotransferase increased	35.7% 5/14 • Number of events 8 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Musculoskeletal and connective tissue disorders Back pain	28.6% 4/14 • Number of events 8 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Musculoskeletal and connective tissue disorders Bone pain	14.3% 2/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Infections and infestations Bronchial infection	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Musculoskeletal and connective tissue disorders Buttock pain	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Investigations Cardiac troponin I increased	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Musculoskeletal and connective tissue disorders Chest wall pain	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
General disorders Chills	14.3% 2/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Psychiatric disorders Confusion	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Infections and infestations Conjunctivitis infective	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Gastrointestinal disorders Constipation	50.0% 7/14 • Number of events 11 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Respiratory, thoracic and mediastinal disorders Cough	35.7% 5/14 • Number of events 8 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Investigations Creatinine increased	35.7% 5/14 • Number of events 15 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Metabolism and nutrition disorders Dehydration	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Gastrointestinal disorders Dental caries	7.1% 1/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Psychiatric disorders Depression	14.3% 2/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Gastrointestinal disorders Diarrhea	64.3% 9/14 • Number of events 28 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Nervous system disorders Dizziness	50.0% 7/14 • Number of events 11 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Gastrointestinal disorders Dry mouth	14.3% 2/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Skin and subcutaneous tissue disorders Dry skin	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Infections and infestations Duodenal infection	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Gastrointestinal disorders Duodenal ulcer	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Nervous system disorders Dysgeusia	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Reproductive system and breast disorders Dyspareunia	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Gastrointestinal disorders Dysphagia	21.4% 3/14 • Number of events 4 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Respiratory, thoracic and mediastinal disorders Dyspnea	64.3% 9/14 • Number of events 13 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Ear and labyrinth disorders Ear pain	7.1% 1/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
General disorders Edema limbs	21.4% 3/14 • Number of events 3 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Infections and infestations Enterocolitis infectious	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Respiratory, thoracic and mediastinal disorders Epistaxis	14.3% 2/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Ear and labyrinth disorders External ear inflammation	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Eye disorders Eye pain	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
General disorders Facial pain	7.1% 1/14 • Number of events 3 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Injury, poisoning and procedural complications Fall	21.4% 3/14 • Number of events 4 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
General disorders Fatigue	92.9% 13/14 • Number of events 33 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
General disorders Fever	35.7% 5/14 • Number of events 8 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Musculoskeletal and connective tissue disorders Flank pain	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Gastrointestinal disorders Flatulence	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Gastrointestinal disorders Gastroesophageal reflux disease	21.4% 3/14 • Number of events 4 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	14.3% 2/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Nervous system disorders Headache	35.7% 5/14 • Number of events 9 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Ear and labyrinth disorders Hearing impaired	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Cardiac disorders Heart failure	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Vascular disorders Hematoma	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Respiratory, thoracic and mediastinal disorders Hiccups	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Respiratory, thoracic and mediastinal disorders Hoarseness	50.0% 7/14 • Number of events 8 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Vascular disorders Hot flashes	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Metabolism and nutrition disorders Hypercalcemia	21.4% 3/14 • Number of events 13 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Skin and subcutaneous tissue disorders Hyperhidrosis	28.6% 4/14 • Number of events 6 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Metabolism and nutrition disorders Hyperkalemia	42.9% 6/14 • Number of events 13 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Vascular disorders Hypertension	100.0% 14/14 • Number of events 345 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Metabolism and nutrition disorders Hypoalbuminemia	50.0% 7/14 • Number of events 20 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Metabolism and nutrition disorders Hypocalcemia	14.3% 2/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Metabolism and nutrition disorders Hypoglycemia	7.1% 1/14 • Number of events 3 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Metabolism and nutrition disorders Hypokalemia	7.1% 1/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Metabolism and nutrition disorders Hypomagnesemia	21.4% 3/14 • Number of events 3 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Metabolism and nutrition disorders Hyponatremia	50.0% 7/14 • Number of events 8 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Metabolism and nutrition disorders Hypophosphatemia	28.6% 4/14 • Number of events 18 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Vascular disorders Hypotension	35.7% 5/14 • Number of events 11 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Endocrine disorders Hypothyroidism	35.7% 5/14 • Number of events 8 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Respiratory, thoracic and mediastinal disorders Hypoxia	14.3% 2/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Psychiatric disorders Insomnia	21.4% 3/14 • Number of events 3 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Respiratory, thoracic and mediastinal disorders Laryngopharyngeal dysesthesia	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Investigations Lipase increased	14.3% 2/14 • Number of events 3 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Infections and infestations Lung infection	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Investigations Lymphocyte count decreased	85.7% 12/14 • Number of events 42 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Investigations Lymphocyte count increased	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
General disorders Malaise	14.3% 2/14 • Number of events 5 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Cardiac disorders Mitral valve disease	7.1% 1/14 • Number of events 3 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Gastrointestinal disorders Mucositis oral	50.0% 7/14 • Number of events 44 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
General disorders Multi-organ failure	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	7.1% 1/14 • Number of events 3 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Musculoskeletal and connective tissue disorders Myalgia	7.1% 1/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Skin and subcutaneous tissue disorders Nail loss	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Gastrointestinal disorders Nausea	64.3% 9/14 • Number of events 25 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Musculoskeletal and connective tissue disorders Neck pain	14.3% 2/14 • Number of events 4 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Investigations Neutrophil count decreased	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	14.3% 2/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Ear and labyrinth disorders Otitis externa	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Ear and labyrinth disorders Otitis media	7.1% 1/14 • Number of events 3 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
General disorders Pain	21.4% 3/14 • Number of events 3 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Musculoskeletal and connective tissue disorders Pain in extremity	42.9% 6/14 • Number of events 12 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Skin and subcutaneous tissue disorders Pain of skin	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	42.9% 6/14 • Number of events 12 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Cardiac disorders Palpitations	35.7% 5/14 • Number of events 9 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Nervous system disorders Paresthesia	14.3% 2/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Cardiac disorders Pericardial effusion	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Reproductive system and breast disorders Perineal pain	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Nervous system disorders Peripheral sensory neuropathy	14.3% 2/14 • Number of events 3 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Psychiatric disorders Personality change	14.3% 2/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Infections and infestations Pharyngitis	14.3% 2/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Investigations Platelet count decreased	42.9% 6/14 • Number of events 16 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Respiratory, thoracic and mediastinal disorders Pleural effusion	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Nervous system disorders Presyncope	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Renal and urinary disorders Proteinuria	35.7% 5/14 • Number of events 10 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	7.1% 1/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Cardiac disorders Pulmonary valve disease	7.1% 1/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Skin and subcutaneous tissue disorders Purpura	14.3% 2/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Skin and subcutaneous tissue disorders Rash acneiform	21.4% 3/14 • Number of events 3 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Skin and subcutaneous tissue disorders Rash maculo-papular	7.1% 1/14 • Number of events 5 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Gastrointestinal disorders Rectal hemorrhage	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Gastrointestinal disorders Rectal mucositis	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Renal and urinary disorders Renal and urinary disorders - Other, cystocele	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Infections and infestations Rhinitis infective	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Investigations Serum amylase increased	14.3% 2/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Cardiac disorders Sinus bradycardia	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Cardiac disorders Sinus tachycardia	21.4% 3/14 • Number of events 4 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Infections and infestations Sinusitis	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Skin and subcutaneous tissue disorders Skin induration	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Respiratory, thoracic and mediastinal disorders Sneezing	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Cardiac disorders Supraventricular tachycardia	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Nervous system disorders Syncope	14.3% 2/14 • Number of events 3 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Infections and infestations Tooth infection	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Gastrointestinal disorders Toothache	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Nervous system disorders Tremor	14.3% 2/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Cardiac disorders Tricuspid valve disease	7.1% 1/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Infections and infestations Upper respiratory infection	42.9% 6/14 • Number of events 9 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Infections and infestations Urinary tract infection	21.4% 3/14 • Number of events 3 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Skin and subcutaneous tissue disorders Urticaria	14.3% 2/14 • Number of events 3 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Reproductive system and breast disorders Vaginal hemorrhage	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Infections and infestations Vaginal infection	7.1% 1/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Reproductive system and breast disorders Vaginal inflammation	7.1% 1/14 • Number of events 2 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Reproductive system and breast disorders Vaginal stricture	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Reproductive system and breast disorders Vaginismus	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Ear and labyrinth disorders Vertigo	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Respiratory, thoracic and mediastinal disorders Voice alteration	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Gastrointestinal disorders Vomiting	42.9% 6/14 • Number of events 14 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Investigations Weight gain	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Investigations Weight loss	35.7% 5/14 • Number of events 10 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Investigations White blood cell decreased	42.9% 6/14 • Number of events 13 • Date treatment consent signed to date off study, approximately 54 months and 29 days.
Renal and urinary disorders Renal and urinary disorders - Other, hydronephrosis	7.1% 1/14 • Number of events 1 • Date treatment consent signed to date off study, approximately 54 months and 29 days.

Additional Information

Dr. Andrea Apolo

National Cancer Institute

Phone: 301-480-0536

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place