Trial Outcomes & Findings for Ixabepilone in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy (NCT NCT00025155)
NCT ID: NCT00025155
Last Updated: 2019-07-24
Results Overview
Percentage of participants with complete and partial tumor response as assessed by the Gynecologic Oncology Group Response Evaluation Criteria in Solid Tumors (GOG RECIST) with one-sided 90% Confidence Interval. Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), \>=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion, or a 50% decrease in the LD in the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
Every other cycle until the completion of study treatment with an average of study treatment time as of 3 months.
Results posted on
2019-07-24
Participant Flow
Participant milestones
| Measure |
Treatment (Ixabepilone)
Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
49
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Ixabepilone)
Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
|
|---|---|
|
Overall Study
Ineligible: Wrong primary cancer site
|
1
|
|
Overall Study
Ineligible: Second primary cancer site
|
1
|
Baseline Characteristics
Ixabepilone in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy
Baseline characteristics by cohort
| Measure |
Treatment (Ixabepilone)
n=49 Participants
Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
|
|---|---|
|
Age, Customized
20-29 years
|
1 participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
0 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
6 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
13 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
15 participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
13 participants
n=5 Participants
|
|
Age, Customized
80-89 years
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
|
International Federation of Gynecology and Obstetrics (FIGO) Stage - Recurrent/Persistent
|
49 participants
n=5 Participants
|
|
Histologic Type
Adenocarcinoma, unspecified
|
1 participants
n=5 Participants
|
|
Histologic Type
Clear Cell Carcinoma
|
4 participants
n=5 Participants
|
|
Histologic Type
Endometrioid Adenocarcinoma
|
2 participants
n=5 Participants
|
|
Histologic Type
Mixed Epithelial Carcinoma
|
3 participants
n=5 Participants
|
|
Histologic Type
Mucinous Adenocarcinoma
|
1 participants
n=5 Participants
|
|
Histologic Type
Serous Adenocarcinoma
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every other cycle until the completion of study treatment with an average of study treatment time as of 3 months.Population: Eligible and treated participants.
Percentage of participants with complete and partial tumor response as assessed by the Gynecologic Oncology Group Response Evaluation Criteria in Solid Tumors (GOG RECIST) with one-sided 90% Confidence Interval. Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), \>=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion, or a 50% decrease in the LD in the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.
Outcome measures
| Measure |
Treatment (Ixabepilone)
n=49 Participants
Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
|
Grade 1
Number of patients who experienced a grade 1 event using Common Toxicity Criteria version 2.0
|
Grade 2
Number of patients who experienced a grade 2 event using Common Toxicity Criteria version 2.0
|
Grade 3
Number of patients who experienced a grade 3 event using Common Toxicity Criteria version 2.0
|
Grade 4
Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0
|
|---|---|---|---|---|---|
|
Tumor Response
|
14.3 percentage of participants
Interval 8.0 to 100.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Every cycle until completion of study treatment up to 30 days after stopping study treatmentPopulation: Eligible and treated patients
Outcome measures
| Measure |
Treatment (Ixabepilone)
n=49 Participants
Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
|
Grade 1
n=49 Participants
Number of patients who experienced a grade 1 event using Common Toxicity Criteria version 2.0
|
Grade 2
n=49 Participants
Number of patients who experienced a grade 2 event using Common Toxicity Criteria version 2.0
|
Grade 3
n=49 Participants
Number of patients who experienced a grade 3 event using Common Toxicity Criteria version 2.0
|
Grade 4
n=49 Participants
Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0
|
|---|---|---|---|---|---|
|
Number of People With Adverse Effects
Genitourinary/Renal
|
41 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of People With Adverse Effects
Leukopenia
|
13 Participants
|
9 Participants
|
20 Participants
|
6 Participants
|
1 Participants
|
|
Number of People With Adverse Effects
Thrombocytopenia
|
39 Participants
|
10 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of People With Adverse Effects
Neutropenia
|
17 Participants
|
10 Participants
|
12 Participants
|
9 Participants
|
1 Participants
|
|
Number of People With Adverse Effects
Anemia
|
9 Participants
|
23 Participants
|
13 Participants
|
4 Participants
|
0 Participants
|
|
Number of People With Adverse Effects
Hematologic
|
43 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of People With Adverse Effects
Allergy
|
46 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of People With Adverse Effects
Cardiovascular
|
45 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of People With Adverse Effects
Coagulation
|
47 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of People With Adverse Effects
Fatigue
|
11 Participants
|
16 Participants
|
15 Participants
|
6 Participants
|
1 Participants
|
|
Number of People With Adverse Effects
Dermatologic
|
23 Participants
|
13 Participants
|
13 Participants
|
0 Participants
|
0 Participants
|
|
Number of People With Adverse Effects
Hemorrhage
|
48 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of People With Adverse Effects
Endocrine
|
48 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of People With Adverse Effects
Gastrointestinal
|
10 Participants
|
15 Participants
|
14 Participants
|
9 Participants
|
1 Participants
|
|
Number of People With Adverse Effects
Hepatic
|
36 Participants
|
10 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of People With Adverse Effects
Infection
|
43 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of People With Adverse Effects
Metabolic
|
36 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Number of People With Adverse Effects
Neurologic
|
20 Participants
|
12 Participants
|
14 Participants
|
3 Participants
|
0 Participants
|
|
Number of People With Adverse Effects
Ocular
|
48 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of People With Adverse Effects
Pain
|
29 Participants
|
10 Participants
|
8 Participants
|
1 Participants
|
1 Participants
|
|
Number of People With Adverse Effects
Pulmonary
|
37 Participants
|
1 Participants
|
9 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From study entry to disease progression, death or date of last contact, whichever occurs first. Every other cycle, up to 5 years of follow-upPopulation: Eligible and treated participants.
Progression-Free Survival is the period from study entry until disease progression, death or date of last contact, whichever occurs first. Progression is defined as at least a 20% increase in the sum of the longest dimensions (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or a 50% increase in the LD taking as reference the smallest LD recorded since study entry in the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions, or global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or death due to disease without prior objective documentation of progression.
Outcome measures
| Measure |
Treatment (Ixabepilone)
n=49 Participants
Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
|
Grade 1
Number of patients who experienced a grade 1 event using Common Toxicity Criteria version 2.0
|
Grade 2
Number of patients who experienced a grade 2 event using Common Toxicity Criteria version 2.0
|
Grade 3
Number of patients who experienced a grade 3 event using Common Toxicity Criteria version 2.0
|
Grade 4
Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0
|
|---|---|---|---|---|---|
|
Progression Free Survival
|
4.4 Months
Interval 2.2 to 5.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry to death or last contact, up to 5 years of follow-up.Population: Eligible and treated participants.
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Outcome measures
| Measure |
Treatment (Ixabepilone)
n=49 Participants
Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
|
Grade 1
Number of patients who experienced a grade 1 event using Common Toxicity Criteria version 2.0
|
Grade 2
Number of patients who experienced a grade 2 event using Common Toxicity Criteria version 2.0
|
Grade 3
Number of patients who experienced a grade 3 event using Common Toxicity Criteria version 2.0
|
Grade 4
Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0
|
|---|---|---|---|---|---|
|
Overall Survival
|
14.8 Months
Interval 9.9 to 17.5
|
—
|
—
|
—
|
—
|
Adverse Events
Treatment (Ixabepilone)
Serious events: 16 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Ixabepilone)
n=49 participants at risk
Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Cardiac disorders
Thrombosis Embolism
|
4.1%
2/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Rigors Chills
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Ascites Non-Malignant
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Diarrhea Without Colostomy
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Dehydration
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
GI Other
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Infection Without Neutropenia
|
6.1%
3/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes/Stridor/Larynx
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Creatinine
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Incontinence
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Proteinuria
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
Other adverse events
| Measure |
Treatment (Ixabepilone)
n=49 participants at risk
Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
|
|---|---|
|
General disorders
Pain Other
|
10.2%
5/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain Tumor
|
4.1%
2/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Neuropathic Pain
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Headache
|
12.2%
6/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.2%
5/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.1%
2/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypomagnesmia
|
22.4%
11/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Extrapyramidal
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Confusion
|
6.1%
3/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Mood Alteration Anxiety/Agitation
|
10.2%
5/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Memory Loss
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Insomnia
|
10.2%
5/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Dizziness
|
6.1%
3/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Mood Alteration Depression
|
10.2%
5/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Neuropathy Cranial
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Neuropathy Sensor
|
59.2%
29/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Neuropathy Motor
|
4.1%
2/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Eye disorders
Vision Blurred
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Abdominal Pain
|
28.6%
14/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Immune system disorders
Allergic Rhinitis
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Immune system disorders
Allergic Reaction
|
6.1%
3/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Ear and labyrinth disorders
Inner Ear/Hearing
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Blood and lymphatic system disorders
Neutropenia
|
65.3%
32/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.4%
10/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.1%
3/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Blood and lymphatic system disorders
Leukopenia
|
73.5%
36/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Blood and lymphatic system disorders
Transfusion Prbc's
|
8.2%
4/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Blood and lymphatic system disorders
Anemia
|
85.7%
42/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Cardiac disorders
Hypotension
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Cardiac disorders
Sinus Tachycardia
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Cardiac disorders
Edema
|
8.2%
4/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Cardiac disorders
Thrombosis Embolism
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Cardiac disorders
Hypertension
|
8.2%
4/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Prothrombin Time
|
4.1%
2/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Partial Thromboplastin Time
|
4.1%
2/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Fever(No Neutropenia)
|
6.1%
3/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Weight Loss
|
10.2%
5/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Rigors Chills
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Weight Gain(No Vod)
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Constitutional Symptoms Other
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Fatigue
|
79.6%
39/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
40.8%
20/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Rash Desquamation
|
12.2%
6/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Skin Other
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
12.2%
6/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
6.1%
3/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Endocrine disorders
Hot Flashes/Flushes
|
4.1%
2/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Sense Of Smell
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Anorexia
|
26.5%
13/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Flatulence
|
6.1%
3/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Mouth Dryness
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Gastritis
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Dyspepsia/Heartburn
|
10.2%
5/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Taste Disturbance
|
14.3%
7/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Dysphagia Esophagitis Odynophagia
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Diarrhea Without Colostomy
|
42.9%
21/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Constipation
|
32.7%
16/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Mucositis Rt
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Stomatitis/Pharyngitis
|
6.1%
3/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Dehydration
|
12.2%
6/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Vomitting
|
24.5%
12/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Nausea
|
44.9%
22/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Gi Other
|
8.2%
4/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Rectal Bleeding/Hematochezia
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Hematuria No Vaginal Bleeding
|
4.1%
2/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Hepatobiliary disorders
Ggt(Gamma-Glutamyltranspeptidase)
|
4.1%
2/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Hepatobiliary disorders
Hepatic Other
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
8.2%
4/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Hepatobiliary disorders
Sgot(Alt)
|
8.2%
4/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Hepatobiliary disorders
Sgot(Ast)
|
16.3%
8/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Hepatobiliary disorders
Alkaline Phosphatase
|
14.3%
7/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Hepatobiliary disorders
Bilirubin
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Infection Without Neutropenia
|
20.4%
10/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Febrile With Neutropenia
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Blood and lymphatic system disorders
Lymphatics Other
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Blood and lymphatic system disorders
Lymphatics
|
6.1%
3/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.1%
3/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Metabolic Other
|
6.1%
3/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.3%
7/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.1%
3/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.4%
10/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pelvic Pain
|
4.1%
2/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Chest Pain
|
4.1%
2/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Bone Pain
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Arthralgia
|
14.3%
7/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Myalgia
|
14.3%
7/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain Rectal/Perirectal
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes/Stridor/Larynx
|
6.1%
3/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Other
|
6.1%
3/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
3/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/Pulmonary Infiltrates
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
4.1%
2/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
24.5%
12/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Urinary Frequency/Urgency
|
4.1%
2/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Dysuria
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Creatinine
|
6.1%
3/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Renal/Gu Other
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Incontinence
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Proteinuria
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Syndromes Other
|
2.0%
1/49 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
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