Trial Outcomes & Findings for Selumetinib in Treating Patients With Recurrent or Persistent Endometrial Cancer (NCT NCT01011933)

NCT ID: NCT01011933

Last Updated: 2019-07-23

Results Overview

Number of participants who survived progression-free for more than 6 months. Progression is defined using Response Evaluation Criteria for Solid Tumors (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions in the opinion of the treating physician, or global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

54 participants

Primary outcome timeframe

> 6 months from study entry

Results posted on

2019-07-23

Participant Flow

The study initially opened 9/8/2009 and enrolled 28 participants. It was suspended on 5/17/2010 and re-opened 5/2/2011, enrolling an additional 26 participants until it was closed on 10/24/2011.

Participant milestones

Participant milestones
Measure	Treatment (Selumetinib) Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
Overall Study STARTED	54
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Selumetinib) Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
Overall Study Wrong cell type	1
Overall Study Improper pre-protocol Rx	1
Overall Study Inadequate pathology	1
Overall Study Never treated	1

Baseline Characteristics

Selumetinib in Treating Patients With Recurrent or Persistent Endometrial Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Selumetinib) n=50 Participants Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
Age, Continuous	62.8 years STANDARD_DEVIATION 9.7 • n=99 Participants
Age, Customized 40-49 years	4 participants n=99 Participants
Age, Customized 50-59 years	15 participants n=99 Participants
Age, Customized 60-69 years	18 participants n=99 Participants
Age, Customized 70-79 years	11 participants n=99 Participants
Age, Customized 80-89 years	2 participants n=99 Participants
Sex: Female, Male Female	50 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Region of Enrollment United States	50 participants n=99 Participants
Cell Type Clear cell carcinoma	1 participants n=99 Participants
Cell Type Endometrioid adenocarcinoma	31 participants n=99 Participants
Cell Type Mixed epithelial carcinoma	10 participants n=99 Participants
Cell Type Serous adenocarcinoma	8 participants n=99 Participants

PRIMARY outcome

Timeframe: > 6 months from study entry

Outcome measures

Outcome measures
Measure	Treatment (Selumetinib) n=50 Participants Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.	Grade 1 (CTCAE v 3.0) Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0	Grade 2 (CTCAE v 3.0) Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0	Grade 3 (CTCAE v 3.0) Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0	Grade 4 (CTCAE v 3.0) Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0	Grade 5 (CTCAE v 3.0) Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
Number of Participants With or Without Progression-free Survival for > 6 Months by Response Evaluation Criteria for Solid Tumors (RECIST) without progression-free survival	39 participants	—	—	—	—	—
Number of Participants With or Without Progression-free Survival for > 6 Months by Response Evaluation Criteria for Solid Tumors (RECIST) with progression-free survival	11 participants	—	—	—	—	—

PRIMARY outcome

Timeframe: From study entry, assessed up to 5 years

Per Response Evaluation Criteria In Solid Tumors (RECIST) Criteria: Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Normalization of CA125, if elevated at study entry, is required; Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD; Increasing Disease is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry; Stable Disease is any condition not meeting the above criteria.

Outcome measures

Outcome measures
Measure	Treatment (Selumetinib) n=50 Participants Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.	Grade 1 (CTCAE v 3.0) Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0	Grade 2 (CTCAE v 3.0) Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0	Grade 3 (CTCAE v 3.0) Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0	Grade 4 (CTCAE v 3.0) Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0	Grade 5 (CTCAE v 3.0) Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
Objective Tumor Response Rate Assessed by RECIST Complete Response	1 participants	—	—	—	—	—
Objective Tumor Response Rate Assessed by RECIST Increase Disease	23 participants	—	—	—	—	—
Objective Tumor Response Rate Assessed by RECIST Partial Response	2 participants	—	—	—	—	—
Objective Tumor Response Rate Assessed by RECIST Stable Disease	13 participants	—	—	—	—	—
Objective Tumor Response Rate Assessed by RECIST Indeterminate	11 participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Each cycle during treatment and 30 days after the last treatment.

Population: Eligible and evaluable patients

Outcome measures

Outcome measures
Measure	Treatment (Selumetinib) n=52 Participants Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.	Grade 1 (CTCAE v 3.0) n=52 Participants Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0	Grade 2 (CTCAE v 3.0) n=52 Participants Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0	Grade 3 (CTCAE v 3.0) n=52 Participants Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0	Grade 4 (CTCAE v 3.0) n=52 Participants Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0	Grade 5 (CTCAE v 3.0) n=52 Participants Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0 Leukopenia	39 Participants	11 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0 Thrombocytopenia	48 Participants	4 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0 Neutropenia	45 Participants	3 Participants	2 Participants	2 Participants	0 Participants	0 Participants
Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0 Anemia	21 Participants	10 Participants	16 Participants	4 Participants	1 Participants	0 Participants
Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0 Auditory/Ear	51 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0 Cardiac	45 Participants	2 Participants	2 Participants	3 Participants	0 Participants	0 Participants
Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0 Coagulation	51 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0 Constitutional	16 Participants	18 Participants	10 Participants	8 Participants	0 Participants	0 Participants
Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0 Dermatologic	16 Participants	13 Participants	18 Participants	5 Participants	0 Participants	0 Participants
Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0 Gastrointestinal	9 Participants	18 Participants	19 Participants	6 Participants	0 Participants	0 Participants
Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0 Genitourinary/Renal	50 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0 Hemorrhage	47 Participants	4 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0 Hepatobiliary	51 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0 Infection	51 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0 Lymphatics	31 Participants	10 Participants	7 Participants	4 Participants	0 Participants	0 Participants
Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0 Metabolic	34 Participants	9 Participants	3 Participants	6 Participants	0 Participants	0 Participants
Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0 Neuropathy	49 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0 Other Neurological	44 Participants	5 Participants	0 Participants	3 Participants	0 Participants	0 Participants
Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0 Ocular/Visual	48 Participants	1 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0 Pain	33 Participants	8 Participants	6 Participants	5 Participants	0 Participants	0 Participants
Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0 Pulmonary	40 Participants	6 Participants	3 Participants	3 Participants	0 Participants	0 Participants
Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0 Sexual/Reproductive	51 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0 Vascular	51 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Every other cycle for the first 6 months; then every 3 months thereafter for up to 5 years

Population: Eligible and treated patients

Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure	Treatment (Selumetinib) n=52 Participants Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.	Grade 1 (CTCAE v 3.0) Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0	Grade 2 (CTCAE v 3.0) Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0	Grade 3 (CTCAE v 3.0) Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0	Grade 4 (CTCAE v 3.0) Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0	Grade 5 (CTCAE v 3.0) Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
Duration of Progression-free Survival	2.3 months Interval 1.7 to 5.6	—	—	—	—	—

SECONDARY outcome

Timeframe: Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.

Population: Eligible and treated patients

Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

Outcome measures

Outcome measures
Measure	Treatment (Selumetinib) n=52 Participants Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.	Grade 1 (CTCAE v 3.0) Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0	Grade 2 (CTCAE v 3.0) Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0	Grade 3 (CTCAE v 3.0) Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0	Grade 4 (CTCAE v 3.0) Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0	Grade 5 (CTCAE v 3.0) Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
Duration of Overall Survival	8.5 months Interval 3.5 to 15.5	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: from study entry until end of study treatment, up to 5 years.

Outcome measures

Outcome measures
Measure	Treatment (Selumetinib) n=50 Participants Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.	Grade 1 (CTCAE v 3.0) Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0	Grade 2 (CTCAE v 3.0) Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0	Grade 3 (CTCAE v 3.0) Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0	Grade 4 (CTCAE v 3.0) Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0	Grade 5 (CTCAE v 3.0) Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
Number of Participants Off Study Therapy for Each Reason Specified. Disease progression	32 participants	—	—	—	—	—
Number of Participants Off Study Therapy for Each Reason Specified. Refused further treatment	5 participants	—	—	—	—	—
Number of Participants Off Study Therapy for Each Reason Specified. Toxicity as permitted	6 participants	—	—	—	—	—
Number of Participants Off Study Therapy for Each Reason Specified. Death	2 participants	—	—	—	—	—
Number of Participants Off Study Therapy for Each Reason Specified. Unspecified	2 participants	—	—	—	—	—
Number of Participants Off Study Therapy for Each Reason Specified. Other - MD decision	1 participants	—	—	—	—	—
Number of Participants Off Study Therapy for Each Reason Specified. Other - AZD6244 contraindicated w/Amiodarone	1 participants	—	—	—	—	—
Number of Participants Off Study Therapy for Each Reason Specified. Other - PT never received any study drug	1 participants	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Study entry up to 2 years

Patients alive or dead after 24 months from time of study entry.

Outcome measures

Outcome measures
Measure	Treatment (Selumetinib) n=50 Participants Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.	Grade 1 (CTCAE v 3.0) Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0	Grade 2 (CTCAE v 3.0) Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0	Grade 3 (CTCAE v 3.0) Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0	Grade 4 (CTCAE v 3.0) Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0	Grade 5 (CTCAE v 3.0) Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
Patient Vital Status Dead, from undetermined cause	1 participants	—	—	—	—	—
Patient Vital Status Dead, unspecified	1 participants	—	—	—	—	—
Patient Vital Status Alive, without disease progression	7 participants	—	—	—	—	—
Patient Vital Status Alive, with disease progression	4 participants	—	—	—	—	—
Patient Vital Status Dead, from disease	37 participants	—	—	—	—	—

Adverse Events

Treatment (Selumetinib)

Serious events: 32 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Selumetinib) n=50 participants at risk Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
Blood and lymphatic system disorders Leukocytes	2.0% 1/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Blood and lymphatic system disorders Hemoglobin	2.0% 1/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Cardiac disorders S/N Arrhythmia: Atrial Fibrillation	2.0% 1/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Cardiac disorders Hypotension	4.0% 2/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
General disorders Death No Ctcae Term - Disease Progression Nos	6.0% 3/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
General disorders Death No Ctcae Term - Death Nos	2.0% 1/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Skin and subcutaneous tissue disorders Rash	2.0% 1/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Gastrointestinal disorders Dysphagia	2.0% 1/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Gastrointestinal disorders Mucositis (Functional/Sympt) - Oral Cavity	4.0% 2/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Gastrointestinal disorders Obstruction, Gi - Small Bowel Nos	2.0% 1/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Gastrointestinal disorders Dehydration	2.0% 1/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Gastrointestinal disorders Constipation	2.0% 1/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Vascular disorders Hemorrhage, Gi - Rectum	2.0% 1/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Hepatobiliary disorders Liver Dysfunction	2.0% 1/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Infections and infestations Inf Unknown Anc: Skin (Cellulitis)	2.0% 1/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Blood and lymphatic system disorders Edema: Limb	2.0% 1/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Metabolism and nutrition disorders Hyponatremia	2.0% 1/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Nervous system disorders Dizziness	2.0% 1/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Nervous system disorders Neuropathy-Sensory	2.0% 1/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Eye disorders Ocular/Visual - Other	2.0% 1/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
General disorders Pain: Chest /Thorax Nos	2.0% 1/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
General disorders Pain: Abdominal Pain Nos	2.0% 1/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.0% 3/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Renal and urinary disorders Obstruction, Gu - Ureter	2.0% 1/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Reproductive system and breast disorders Vaginitis	2.0% 1/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Vascular disorders Thrombosis/Thrombus/Embolism	10.0% 5/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.

Other adverse events

Other adverse events
Measure	Treatment (Selumetinib) n=50 participants at risk Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 10/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Respiratory, thoracic and mediastinal disorders Dyspnea	26.0% 13/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Vascular disorders Thrombosis/Thrombus/Embolism	12.0% 6/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Blood and lymphatic system disorders Neutrophils	16.0% 8/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Blood and lymphatic system disorders Platelets	14.0% 7/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Blood and lymphatic system disorders Leukocytes	26.0% 13/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Blood and lymphatic system disorders Hemoglobin	70.0% 35/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Cardiac disorders Hypotension	6.0% 3/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Vascular disorders Ptt	6.0% 3/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
General disorders Weight Gain	10.0% 5/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
General disorders Fever	14.0% 7/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
General disorders Rigors/Chills	6.0% 3/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
General disorders Fatigue	76.0% 38/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
General disorders Insomnia	6.0% 3/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Skin and subcutaneous tissue disorders Acne	30.0% 15/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Skin and subcutaneous tissue disorders Rash	48.0% 24/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Skin and subcutaneous tissue disorders Dry Skin	20.0% 10/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Skin and subcutaneous tissue disorders Pruritus	6.0% 3/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Gastrointestinal disorders Flatulence	6.0% 3/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Gastrointestinal disorders Heartburn	6.0% 3/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Gastrointestinal disorders Taste Alteration	8.0% 4/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Gastrointestinal disorders Dry Mouth	8.0% 4/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Gastrointestinal disorders Mucositis (Clinical Exam) - Oral Cavity	6.0% 3/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Gastrointestinal disorders Vomiting	42.0% 21/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Gastrointestinal disorders Anorexia	22.0% 11/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Gastrointestinal disorders Constipation	32.0% 16/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Gastrointestinal disorders Nausea	68.0% 34/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Gastrointestinal disorders Diarrhea	58.0% 29/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Vascular disorders Hemorrhage/Pulmonary - Nose	8.0% 4/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos	8.0% 4/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Blood and lymphatic system disorders Edema: Trunk/Genital	6.0% 3/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Blood and lymphatic system disorders Edema: Limb	46.0% 23/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Blood and lymphatic system disorders Edema: Head And Neck	12.0% 6/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Metabolism and nutrition disorders Ast	20.0% 10/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Metabolism and nutrition disorders Creatinine	8.0% 4/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Metabolism and nutrition disorders Hypoalbuminemia	20.0% 10/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Metabolism and nutrition disorders Alt	14.0% 7/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Metabolism and nutrition disorders Alkaline Phosphatase	18.0% 9/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Metabolism and nutrition disorders Hypophosphatemia	8.0% 4/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Metabolism and nutrition disorders Hyponatremia	12.0% 6/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Metabolism and nutrition disorders Hypocalcemia	16.0% 8/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Metabolism and nutrition disorders Hyperkalemia	6.0% 3/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Metabolism and nutrition disorders Hyperglycemia	18.0% 9/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Metabolism and nutrition disorders Hypokalemia	8.0% 4/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Metabolism and nutrition disorders Hypoglycemia	6.0% 3/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Metabolism and nutrition disorders Hypomagnesemia	14.0% 7/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Nervous system disorders Mood Alteration - Depression	12.0% 6/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Nervous system disorders Mood Alteration - Anxiety	6.0% 3/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Nervous system disorders Dizziness	6.0% 3/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Nervous system disorders Neuropathy-Sensory	16.0% 8/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
Eye disorders Blurred Vision	10.0% 5/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
General disorders Pain: Extremity-Limb	12.0% 6/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
General disorders Pain: Back	16.0% 8/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
General disorders Pain: Joint	12.0% 6/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.
General disorders Pain: Abdominal Pain Nos	28.0% 14/50 • Adverse Events(AEs) are reported up to 30 days after last treatment. Late AEs can be reported up to 5 years after patient enrollment.

Additional Information

Melissa Leventhal

Gynecologic Oncology Group Statistical and Data Center

Phone: 716-845-4030

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60