Trial Outcomes & Findings for Irofulven in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cancer (NCT NCT00053365)

Last Updated: 2019-07-24

Results Overview

Per Gynecologic Oncology Group(GOG) Response Evaluation Criteria in Solid Tumors(RECIST) Criteria: Complete Response is disappearance of all target and non-target lesions; Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable dimensions; Increasing Disease is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Response is to be evaluated every 42 days for the first 6 months and every 6 months thereafter while the patient is receiving study treatment, then every 3 months for 2 years and every 6 months for the next 3 years until documented progression or death.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

61 participants

Primary outcome timeframe

From entry into study until documented progression or death, assessed up to 5 years.

Results posted on

2019-07-24

Participant Flow

Stage I of the study accrued patients from 6/2/2003 through 10/31/2005. Stage II of the study accrued patients from 1/3/2006 through 4/7/2008.

Participant milestones

Participant milestones
Measure	Treatment (Irofulven) Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
Overall Study STARTED	61
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Irofulven) Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
Overall Study Incorrect cell type	1
Overall Study Platinum-sensitive interval >12 months	1
Overall Study Never treated	4

Baseline Characteristics

Irofulven in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Irofulven) n=55 Participants Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
Age, Continuous	59.2 years STANDARD_DEVIATION 9.7 • n=5 Participants
Age, Customized 30-39 years	1 participants n=5 Participants
Age, Customized 40-49 years	10 participants n=5 Participants
Age, Customized 50-59 years	17 participants n=5 Participants
Age, Customized 60-69 years	21 participants n=5 Participants
Age, Customized 70-79 years	4 participants n=5 Participants
Age, Customized 80-89 years	2 participants n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants
Recurrent/Persistent Disease	55 participants n=5 Participants
Cell Type Endometrioid Adenocarcinoma	2 participants n=5 Participants
Cell Type Mixed Epithelial Carcinoma	3 participants n=5 Participants
Cell Type Serous Adenocarcinoma	47 participants n=5 Participants
Cell Type Undifferentiated Carcinoma	3 participants n=5 Participants

PRIMARY outcome

Timeframe: From entry into study until documented progression or death, assessed up to 5 years.

Outcome measures

Outcome measures
Measure	Treatment (Irofulven) n=55 Participants Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.	Grade 4 (CTCAE v 2.0) Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0
Tumor Response Partial Response	7 participants Interval 0.07 to 0.29	—
Tumor Response Stable Disease	30 participants	—
Tumor Response Increase Disease	12 participants	—
Tumor Response Indeterminate	6 participants	—

PRIMARY outcome

Timeframe: Assessed every cycle while on treatment, 30 days after the last cycle of treatment

Population: Eligible and evaluable patients

Outcome measures

Outcome measures
Measure	Treatment (Irofulven) n=55 Participants Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.	Grade 4 (CTCAE v 2.0) n=55 Participants Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0
Frequency and Severity of Observed Adverse Events, Grade 3 or Higher According to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 Leukopenia	11 participants	0 participants
Frequency and Severity of Observed Adverse Events, Grade 3 or Higher According to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 Thrombocytopenia	11 participants	2 participants
Frequency and Severity of Observed Adverse Events, Grade 3 or Higher According to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 Neutropenia	16 participants	6 participants
Frequency and Severity of Observed Adverse Events, Grade 3 or Higher According to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 Other hematologic	6 participants	0 participants
Frequency and Severity of Observed Adverse Events, Grade 3 or Higher According to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 Constitutional	4 participants	0 participants
Frequency and Severity of Observed Adverse Events, Grade 3 or Higher According to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 Gastrointestinal	8 participants	1 participants
Frequency and Severity of Observed Adverse Events, Grade 3 or Higher According to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 Infection	4 participants	0 participants
Frequency and Severity of Observed Adverse Events, Grade 3 or Higher According to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 Musculoskeletal	2 participants	0 participants
Frequency and Severity of Observed Adverse Events, Grade 3 or Higher According to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 Metabolic	2 participants	1 participants
Frequency and Severity of Observed Adverse Events, Grade 3 or Higher According to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 Neuropathy (sensory)	1 participants	0 participants
Frequency and Severity of Observed Adverse Events, Grade 3 or Higher According to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 Other neurologic	2 participants	0 participants
Frequency and Severity of Observed Adverse Events, Grade 3 or Higher According to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 Ocular	4 participants	0 participants
Frequency and Severity of Observed Adverse Events, Grade 3 or Higher According to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 Pain	1 participants	0 participants

SECONDARY outcome

Timeframe: From entry into study to death or date of last contact, assessed up to 5 years

Population: Eligible and evaluable

Per Gynecologic Oncology Group(GOG) Response Evaluation Criteria in Solid Tumors(RECIST) Criteria, progression is defined as at least a 20% increase in the sum of longest dimesions(LD) of target lesions taking as reference the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.

Outcome measures

Outcome measures
Measure	Treatment (Irofulven) n=55 Participants Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.	Grade 4 (CTCAE v 2.0) Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0
Progression-free Survival Median Overall Survival	24.1 months Interval 17.5 to 28.9	—
Progression-free Survival Median Progression-free Survival	6.7 months Interval 4.1 to 8.9	—

Adverse Events

Treatment (Irofulven)

Serious events: 18 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Irofulven) n=55 participants at risk Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
Cardiac disorders Cardiovascular Other	1.8% 1/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Cardiac disorders Thrombosis Embolism	1.8% 1/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Gastrointestinal disorders Anorexia	3.6% 2/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Gastrointestinal disorders Ileus	1.8% 1/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Gastrointestinal disorders Constipation	1.8% 1/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Gastrointestinal disorders Dehydration	3.6% 2/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Gastrointestinal disorders Vomitting	5.5% 3/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Gastrointestinal disorders Gi Other	3.6% 2/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Infections and infestations Infection Without Neutropenia	3.6% 2/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Metabolism and nutrition disorders Hypomagnesmia	1.8% 1/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Musculoskeletal and connective tissue disorders Muscle Weakness	1.8% 1/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Nervous system disorders Ataxia(Incoordination)	5.5% 3/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Nervous system disorders Neuropathy Sensor	1.8% 1/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Eye disorders Ocular Other	1.8% 1/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Eye disorders Vision Photophobia	3.6% 2/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Eye disorders Vision Blurres	1.8% 1/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.8% 1/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.

Other adverse events

Other adverse events
Measure	Treatment (Irofulven) n=55 participants at risk Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
Blood and lymphatic system disorders Neutropenia	69.1% 38/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Blood and lymphatic system disorders Thrombocytopenia	74.5% 41/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Blood and lymphatic system disorders Lymphopenia	7.3% 4/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Blood and lymphatic system disorders Leukopenia	70.9% 39/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Blood and lymphatic system disorders Transfusion Prbc's	9.1% 5/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Blood and lymphatic system disorders Anemia	81.8% 45/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Cardiac disorders Sinus Tachycardia	5.5% 3/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Cardiac disorders Edema	9.1% 5/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
General disorders Fever(No Neutropenia)	7.3% 4/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
General disorders Sweating	5.5% 3/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
General disorders Fatigue	74.5% 41/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Skin and subcutaneous tissue disorders Pruritis	5.5% 3/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Skin and subcutaneous tissue disorders Alopecia	18.2% 10/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Skin and subcutaneous tissue disorders Rash Desquamation	9.1% 5/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Skin and subcutaneous tissue disorders Bruising	5.5% 3/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Endocrine disorders Hot Flashes/Flushes	12.7% 7/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Gastrointestinal disorders Anorexia	21.8% 12/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Gastrointestinal disorders Flatulence	10.9% 6/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Gastrointestinal disorders Dyspepsia/Heartburn	18.2% 10/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Gastrointestinal disorders Dysphagia Esophagitis Odynophagia	7.3% 4/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Gastrointestinal disorders Diarrhea Without Colostomy	30.9% 17/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Gastrointestinal disorders Constipation	40.0% 22/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Gastrointestinal disorders Stomatitis/Pharyngitis	12.7% 7/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Gastrointestinal disorders Vomitting	40.0% 22/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Gastrointestinal disorders Nausea	69.1% 38/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Vascular disorders Hematuria No Vaginal Bleeding	5.5% 3/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Hepatobiliary disorders Hypoalbuminemia	9.1% 5/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Hepatobiliary disorders Sgot(Alt)	12.7% 7/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Hepatobiliary disorders Sgot(Ast)	9.1% 5/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Hepatobiliary disorders Alkaline Phosphatase	10.9% 6/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Infections and infestations Infection Without Neutropenia	16.4% 9/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Metabolism and nutrition disorders Hyponatremia	5.5% 3/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Metabolism and nutrition disorders Hypocalcemia	9.1% 5/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Metabolism and nutrition disorders Hyperglycemia	14.5% 8/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Metabolism and nutrition disorders Hypokalemia	14.5% 8/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Metabolism and nutrition disorders Hypomagnesmia	18.2% 10/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Musculoskeletal and connective tissue disorders Muscle Weakness	5.5% 3/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Nervous system disorders Ataxia(Incoordination)	5.5% 3/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Nervous system disorders Insomnia	10.9% 6/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Nervous system disorders Dizziness	12.7% 7/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Nervous system disorders Mood Alteration Depression	7.3% 4/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Nervous system disorders Neuropathy Sensor	34.5% 19/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Eye disorders Ocular Other	9.1% 5/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Eye disorders Dry Eye	5.5% 3/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Eye disorders Vision Photophobia	9.1% 5/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Eye disorders Vision Flashing Lights/Floaters	16.4% 9/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Eye disorders Vision Blurres	14.5% 8/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
General disorders Abdominal Pain	32.7% 18/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
General disorders Pain Other	12.7% 7/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
General disorders Headache	30.9% 17/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
General disorders Arthralgia	5.5% 3/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
General disorders Myalgia	14.5% 8/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Respiratory, thoracic and mediastinal disorders Voice Changes/Stridor/Larynx	5.5% 3/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Respiratory, thoracic and mediastinal disorders Cough	7.3% 4/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Respiratory, thoracic and mediastinal disorders Dyspnea	12.7% 7/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Renal and urinary disorders Urinary Retention	5.5% 3/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.
Renal and urinary disorders Proteinuria	5.5% 3/55 • Adverse Events(AEs) considered to be due to study treatment are to be reported up until 5 years after initiating treatment. A patient's AEs are reported following each cycle of study treatment and include AEs occurring within 30 days of each cycle.

Additional Information

Melissa Leventhal

Gynecologic Oncology Group

Phone: 716-845-4030

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60