Trial Outcomes & Findings for Alisertib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus (NCT NCT01637961)

Last Updated: 2019-07-23

Results Overview

Whether or not the patient survived progression-free for at least 6 months. 90% confidence interval (Bonferroni Corrected). Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Progression includes the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Assessed every other cycle for the first 6 months; then every 3 months from the date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.

Results posted on

2019-07-23

Participant Flow

The study was activated on 8/6/2012 and closed to accrual on 6/3/2013.

Participant milestones

Participant milestones
Measure	MLN8237 MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
Overall Study STARTED	23
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	MLN8237 MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
Overall Study Ineligible: wrong primary	1
Overall Study Ineligible: inadequate pathology	1

Baseline Characteristics

Alisertib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MLN8237 n=21 Participants MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
Age, Continuous	60.9 years STANDARD_DEVIATION 9.0 • n=39 Participants
Age, Customized 40-49 years	3 participants n=39 Participants
Age, Customized 50-59 years	6 participants n=39 Participants
Age, Customized 60-69 years	9 participants n=39 Participants
Age, Customized 70-79 years	2 participants n=39 Participants
Age, Customized 80-89 years	1 participants n=39 Participants
Sex: Female, Male Female	21 Participants n=39 Participants
Sex: Female, Male Male	0 Participants n=39 Participants
Region of Enrollment United States	21 participants n=39 Participants
FIGO (International Federation of Gynecology and Obstetrics) Stage - Recurrent/Persistent	21 participants n=39 Participants
Histologic Type - Leiomyosarcoma	21 participants n=39 Participants

PRIMARY outcome

Timeframe: Assessed every other cycle for the first 6 months; then every 3 months from the date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.

Population: Eligible and Treated Patients

Outcome measures

Outcome measures
Measure	MLN8237 n=21 Participants MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.	Grade 1 (CTCAE v 4.0) Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0	Grade 2 (CTCAE v 4.0) Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0	Grade 3 (CTCAE v 4.0) Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0	Grade 4 (CTCAE v 4.0) Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0	Grade 5 (CTCAE v 4.0) Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
Progression-free Survival (PFS) > 6 Months	0.0 percentage of participants Interval 0.0 to 16.1	—	—	—	—	—

PRIMARY outcome

Timeframe: Every other cycle for the first 6 months; then every 3 months thereafter until withdrawal from study treatment or disease progression is confirmed.

Population: Eligible and treated patients

Complete and Partial Tumor Response by RECIST 1.1. Patient response uses best overall response while on therapy. Complete response is defined as the disappearance of all target lesions and non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in the short axis to \<10 mm. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.

Outcome measures

Outcome measures
Measure	MLN8237 n=21 Participants MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.	Grade 1 (CTCAE v 4.0) Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0	Grade 2 (CTCAE v 4.0) Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0	Grade 3 (CTCAE v 4.0) Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0	Grade 4 (CTCAE v 4.0) Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0	Grade 5 (CTCAE v 4.0) Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
Tumor Response	0.0 percentage of participants Interval 0.0 to 16.1	—	—	—	—	—

SECONDARY outcome

Timeframe: From study entry to death or last contact, 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	MLN8237 n=21 Participants MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.	Grade 1 (CTCAE v 4.0) Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0	Grade 2 (CTCAE v 4.0) Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0	Grade 3 (CTCAE v 4.0) Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0	Grade 4 (CTCAE v 4.0) Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0	Grade 5 (CTCAE v 4.0) Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
Overall Survival	13.6 months Interval 5.65 to 17.28	—	—	—	—	—

SECONDARY outcome

Timeframe: Every cycle during treatment and 30 days after the last treatment, up to 5 years.

Population: Eligible and treated patients

Outcome measures

Outcome measures
Measure	MLN8237 n=21 Participants MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.	Grade 1 (CTCAE v 4.0) n=21 Participants Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0	Grade 2 (CTCAE v 4.0) n=21 Participants Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0	Grade 3 (CTCAE v 4.0) n=21 Participants Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0	Grade 4 (CTCAE v 4.0) n=21 Participants Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0	Grade 5 (CTCAE v 4.0) n=21 Participants Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0 Leukopenia	9 Participants	3 Participants	4 Participants	5 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0 Thrombocytopenia	11 Participants	9 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0 Neutropenia	11 Participants	0 Participants	3 Participants	5 Participants	2 Participants	0 Participants
Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0 Anemia	5 Participants	3 Participants	9 Participants	3 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0 Cardiac	20 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0 Nausea	15 Participants	3 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0 General and administration site	9 Participants	5 Participants	7 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0 Infections/infestations	19 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0 Metabolism/nutrition	14 Participants	1 Participants	6 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0 Musculoskeletal/connective tissue	16 Participants	3 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0 Peripheral sensory neuropathy	20 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0 Vascular disorders	19 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0 Other investigations	18 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0 Other blood/lymphatics	19 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0 Vomiting	18 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0 Other gastrointestinal	4 Participants	7 Participants	6 Participants	4 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0 Nervous system	12 Participants	5 Participants	4 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0 Psychiatric	19 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0 Renal/urinary	19 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0 Reproductive/breast	19 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0 Respiratory/thoracic/mediastinal	16 Participants	4 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0 Skin/subcutaneous	7 Participants	5 Participants	7 Participants	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: every other cycle for the first 6 months; then every 3 months thereafter until disease progression is confirmed; up to 5 years

Population: Eligible and treated patients

Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.

Outcome measures

Outcome measures
Measure	MLN8237 n=21 Participants MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.	Grade 1 (CTCAE v 4.0) Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0	Grade 2 (CTCAE v 4.0) Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0	Grade 3 (CTCAE v 4.0) Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0	Grade 4 (CTCAE v 4.0) Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0	Grade 5 (CTCAE v 4.0) Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
Progression Free Survival	1.7 months Interval 1.4 to 3.2	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Aurora A Kinase expression will be assessed for associations with patient demographics and clinical outcome (response, PFS at 6 months, PFS, and OS).

Outcome measures

Outcome data not reported

Adverse Events

MLN8237

Serious events: 5 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MLN8237 n=21 participants at risk MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
Blood and lymphatic system disorders Anemia	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Blood and lymphatic system disorders Febrile Neutropenia	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Cardiac disorders Sinus Tachycardia	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Reproductive system and breast disorders Vaginal Hemorrhage	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodysesthesia Syndrome	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.

Other adverse events

Other adverse events
Measure	MLN8237 n=21 participants at risk MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
Blood and lymphatic system disorders Anemia	71.4% 15/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Blood and lymphatic system disorders Febrile Neutropenia	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Gastrointestinal disorders Dysphagia	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Gastrointestinal disorders Constipation	33.3% 7/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Gastrointestinal disorders Diarrhea	38.1% 8/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Gastrointestinal disorders Vomiting	14.3% 3/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Gastrointestinal disorders Stomach Pain	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Gastrointestinal disorders Abdominal Pain	9.5% 2/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Gastrointestinal disorders Mucositis Oral	42.9% 9/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Gastrointestinal disorders Oral Hemorrhage	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Gastrointestinal disorders Oral Pain	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Gastrointestinal disorders Nausea	28.6% 6/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Gastrointestinal disorders Gastroesophageal Reflux Disease	14.3% 3/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Gastrointestinal disorders Esophagitis	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
General disorders Pain	23.8% 5/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
General disorders Localized Edema	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
General disorders Fatigue	61.9% 13/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
General disorders Fever	9.5% 2/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
General disorders Chills	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Infections and infestations Mucosal Infection	9.5% 2/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Infections and infestations Vaginal Infection	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Investigations Weight Loss	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Investigations Platelet Count Decreased	47.6% 10/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Investigations Neutrophil Count Decreased	47.6% 10/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Investigations White Blood Cell Decreased	57.1% 12/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Investigations Aspartate Aminotransferase Increased	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Investigations Alanine Aminotransferase Increased	9.5% 2/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Metabolism and nutrition disorders Hypokalemia	9.5% 2/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Metabolism and nutrition disorders Hypoalbuminemia	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Metabolism and nutrition disorders Anorexia	14.3% 3/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Musculoskeletal and connective tissue disorders Pain In Extremity	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Musculoskeletal and connective tissue disorders Myalgia	14.3% 3/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Musculoskeletal and connective tissue disorders Back Pain	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Musculoskeletal and connective tissue disorders Arthralgia	9.5% 2/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Nervous system disorders Somnolence	23.8% 5/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Nervous system disorders Peripheral Sensory Neuropathy	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Nervous system disorders Lethargy	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Nervous system disorders Headache	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Nervous system disorders Dysgeusia	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Nervous system disorders Dizziness	9.5% 2/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Psychiatric disorders Insomnia	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Psychiatric disorders Depression	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Renal and urinary disorders Urinary Tract Pain	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Renal and urinary disorders Urinary Frequency	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Reproductive system and breast disorders Vaginal Hemorrhage	9.5% 2/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Respiratory, thoracic and mediastinal disorders Hypoxia	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Respiratory, thoracic and mediastinal disorders Hiccups	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Respiratory, thoracic and mediastinal disorders Dyspnea	9.5% 2/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Respiratory, thoracic and mediastinal disorders Cough	9.5% 2/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Respiratory, thoracic and mediastinal disorders Wheezing	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary Hemorrhage	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Skin and subcutaneous tissue disorders Urticaria	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Skin and subcutaneous tissue disorders Pruritus	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodysesthesia Syndrome	23.8% 5/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	14.3% 3/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Skin and subcutaneous tissue disorders Dry Skin	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Skin and subcutaneous tissue disorders Alopecia	33.3% 7/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Vascular disorders Hypotension	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Vascular disorders Hypertension	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Vascular disorders Hot Flashes	4.8% 1/21 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.

Additional Information

Angela M. Kuras, Associate Director of Data Management

NRG Oncology Statistics and Data Management Center - Buffalo

Phone: 716-845-7733

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60