Trial Outcomes & Findings for Pazopanib Hydrochloride in Treating Patients With Recurrent or Persistent Uterine Cancer (NCT NCT01247571)

Last Updated: 2019-08-08

Results Overview

Complete and Partial Tumor Response by RECIST 1.0. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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

22 participants

Primary outcome timeframe

CT scan or MRI if used to follow lesion(s) for measurable disease every other cycle for the first 6 mnths; then every 3 mnths thereafter until dx progression is confirmed; also repeat any other time clinically indicated, assessed up to 6 months.

Results posted on

2019-08-08

Participant Flow

Participant milestones

Participant milestones
Measure	Pazopanib Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
Overall Study STARTED	22
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pazopanib Hydrochloride in Treating Patients With Recurrent or Persistent Uterine Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pazopanib n=19 Participants Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
Age, Customized 50-59	1 participants n=93 Participants
Age, Customized 60-69	11 participants n=93 Participants
Age, Customized 70-79	7 participants n=93 Participants
Sex: Female, Male Female	19 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: CT scan or MRI if used to follow lesion(s) for measurable disease every other cycle for the first 6 mnths; then every 3 mnths thereafter until dx progression is confirmed; also repeat any other time clinically indicated, assessed up to 6 months.

Population: Eligible and Treated Patients

Outcome measures

Outcome measures
Measure	Pazopanib n=19 Participants Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
Objective Tumor Response (Complete or Partial)	0 percentage of participants Interval 0.0 to 14.6

PRIMARY outcome

Timeframe: 6 months

Population: Eligible and treated patients

Progression-free survival is the period from study entry until disease progression, death or date of last contact. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20 % increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Pazopanib n=19 Participants Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
Percentage of Participants With Progression-free Survival (PFS) at 6 Months	15.8 percentage of participants Interval 4.4 to 35.9

PRIMARY outcome

Timeframe: Every cycle while on treatment

Population: Eligible and Treated Patients

Grade 3 or higher adverse events were graded by CTCAE v4.

Outcome measures

Outcome measures
Measure	Pazopanib n=19 Participants Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
Number of Patients With Grade 3 or Higher Adverse Events Anemia	3 participants
Number of Patients With Grade 3 or Higher Adverse Events Hypertension	3 participants
Number of Patients With Grade 3 or Higher Adverse Events Abdominal pain	2 participants
Number of Patients With Grade 3 or Higher Adverse Events Hyperglycemia	2 participants
Number of Patients With Grade 3 or Higher Adverse Events Hypoglycemia	2 participants
Number of Patients With Grade 3 or Higher Adverse Events Alanine aminotransferase increased	1 participants
Number of Patients With Grade 3 or Higher Adverse Events Ascites	1 participants
Number of Patients With Grade 3 or Higher Adverse Events Aspartate aminotransferase increased	1 participants
Number of Patients With Grade 3 or Higher Adverse Events Creatinine increasead	1 participants
Number of Patients With Grade 3 or Higher Adverse Events Death NOS	1 participants
Number of Patients With Grade 3 or Higher Adverse Events Dehydration	1 participants
Number of Patients With Grade 3 or Higher Adverse Events Diarrhea	1 participants
Number of Patients With Grade 3 or Higher Adverse Events Dyspnea	1 participants
Number of Patients With Grade 3 or Higher Adverse Events Fatigue	1 participants
Number of Patients With Grade 3 or Higher Adverse Events Headache	1 participants
Number of Patients With Grade 3 or Higher Adverse Events Hypocalcemia	1 participants
Number of Patients With Grade 3 or Higher Adverse Events Hyponatremia	1 participants
Number of Patients With Grade 3 or Higher Adverse Events Memory impairment	1 participants
Number of Patients With Grade 3 or Higher Adverse Events Nausea	1 participants
Number of Patients With Grade 3 or Higher Adverse Events Proctitis	1 participants
Number of Patients With Grade 3 or Higher Adverse Events Rectal hemorrhage	1 participants
Number of Patients With Grade 3 or Higher Adverse Events Sepsis	1 participants
Number of Patients With Grade 3 or Higher Adverse Events Vomiting	1 participants

SECONDARY outcome

Timeframe: From start of treatment to time of progression or death, assessed up to 5 years

Population: Eligible and Treated Patients

Progression-free survival is the period from study entry until disease progression, death or date of last contact

Outcome measures

Outcome measures
Measure	Pazopanib n=19 Participants Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
Progression-free Survival	2.0 months Interval 1.6 to 3.6

SECONDARY outcome

Timeframe: Time from start of treatment to time of death or the date of last contact, assessed up to 5 years

Population: Eligible and treated patients

The observed length of life from entry into the study to death or the date of last contact.

Outcome measures

Outcome measures
Measure	Pazopanib n=19 Participants Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
Overall Survival	8.7 months Interval 2.6 to 14.0

Adverse Events

Pazopanib

Serious events: 6 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pazopanib n=19 participants at risk Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
Blood and lymphatic system disorders Anemia	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Abdominal Pain	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
General disorders Death Nos	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Investigations Creatinine Increased	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hypomagnesemia	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Dehydration	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Nervous system disorders Memory Impairment	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Reproductive system and breast disorders Reproductive System And Breast Disorders - Other	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.

Other adverse events

Other adverse events
Measure	Pazopanib n=19 participants at risk Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
Blood and lymphatic system disorders Anemia	47.4% 9/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Cardiac disorders Sinus Bradycardia	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Cardiac disorders Sinus Tachycardia	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Ear and labyrinth disorders Tinnitus	10.5% 2/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Ear and labyrinth disorders Hearing Impaired	10.5% 2/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Ear and labyrinth disorders Ear Pain	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Eye disorders Blurred Vision	15.8% 3/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Dysphagia	15.8% 3/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Dyspepsia	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Dry Mouth	15.8% 3/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Constipation	36.8% 7/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Diarrhea	68.4% 13/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Vomiting	42.1% 8/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Bloating	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Abdominal Pain	36.8% 7/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Proctitis	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Rectal Hemorrhage	10.5% 2/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Mucositis Oral	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Gastrointestinal Pain	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Oral Pain	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Nausea	78.9% 15/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Gastroesophageal Reflux Disease	10.5% 2/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Ascites	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Gastrointestinal disorders Flatulence	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
General disorders Pain	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
General disorders Edema Trunk	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
General disorders Edema Limbs	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
General disorders Fatigue	73.7% 14/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
General disorders Fever	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Infections and infestations Sinusitis	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Infections and infestations Sepsis	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Infections and infestations Urinary Tract Infection	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Injury, poisoning and procedural complications Bruising	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Investigations Investigations - Other	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Investigations Weight Loss	21.1% 4/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Investigations Platelet Count Decreased	10.5% 2/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Investigations Lymphocyte Count Decreased	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Investigations Creatinine Increased	10.5% 2/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Investigations Neutrophil Count Decreased	52.6% 10/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Investigations Blood Bilirubin Increased	15.8% 3/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Investigations White Blood Cell Decreased	52.6% 10/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Investigations Aspartate Aminotransferase Increased	21.1% 4/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Investigations Alkaline Phosphatase Increased	15.8% 3/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Investigations Alanine Aminotransferase Increased	21.1% 4/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hyponatremia	21.1% 4/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hypomagnesemia	15.8% 3/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hypokalemia	10.5% 2/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hypoglycemia	10.5% 2/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hypocalcemia	15.8% 3/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hypoalbuminemia	21.1% 4/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Hyperglycemia	10.5% 2/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Dehydration	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Metabolism and nutrition disorders Anorexia	31.6% 6/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Musculoskeletal and connective tissue disorders Pain In Extremity	21.1% 4/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Musculoskeletal and connective tissue disorders Neck Pain	10.5% 2/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Musculoskeletal and connective tissue disorders Generalized Muscle Weakness	10.5% 2/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Musculoskeletal and connective tissue disorders Back Pain	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Musculoskeletal and connective tissue disorders Arthritis	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	15.8% 3/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Nervous system disorders Peripheral Sensory Neuropathy	42.1% 8/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Nervous system disorders Paresthesia	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Nervous system disorders Memory Impairment	15.8% 3/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Nervous system disorders Headache	31.6% 6/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Nervous system disorders Dysgeusia	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Nervous system disorders Dizziness	10.5% 2/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Psychiatric disorders Insomnia	15.8% 3/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Psychiatric disorders Depression	21.1% 4/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Psychiatric disorders Anxiety	10.5% 2/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Renal and urinary disorders Urinary Retention	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Renal and urinary disorders Urinary Frequency	10.5% 2/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Renal and urinary disorders Proteinuria	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Reproductive system and breast disorders Vaginal Hemorrhage	10.5% 2/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Reproductive system and breast disorders Pelvic Pain	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Reproductive system and breast disorders Vaginal Discharge	10.5% 2/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	15.8% 3/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	31.6% 6/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Respiratory, thoracic and mediastinal disorders Cough	26.3% 5/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Respiratory, thoracic and mediastinal disorders Allergic Rhinitis	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Skin and subcutaneous tissue disorders Skin And Subcutaneous Tissue Disorders - Other	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	10.5% 2/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Skin and subcutaneous tissue disorders Skin Hypopigmentation	10.5% 2/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Skin and subcutaneous tissue disorders Nail Discoloration	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Skin and subcutaneous tissue disorders Dry Skin	5.3% 1/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Skin and subcutaneous tissue disorders Alopecia	21.1% 4/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Vascular disorders Hypertension	52.6% 10/19 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.

Additional Information

Linda Gedeon for William Brady, PhD.

NRG Oncology

Phone: 716-845-1169

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60