Trial Outcomes & Findings for Irinotecan and Bevacizumab for Recurrent Ovarian Cancer (NCT NCT01091259)
NCT ID: NCT01091259
Last Updated: 2015-11-24
Results Overview
The PFS rate at 6 months is the percentage of patients that experience a PFS event during the first 6 months in the study. The PFS is defined as the time from date of first dose of study medication to the date of first documented disease progression, or death from any cause, whichever is first. Patients who die without a reported prior progression will be considered to have progressed on the day of their death. Progression is evaluated by Response and Evaluation Criteria in Solid Tumor (RECIST) 1.0 or CA125 criteria if no measurable disease as doubling of CA125 levels from either the upper limit of normal or the nadir CA125 level.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
6 months from the start of treatment
Results posted on
2015-11-24
Participant Flow
From April 2010 to May 2013, 29 patients were enrolled from New York University Langone Medical Center.
Participant milestones
| Measure |
Irinotecan With Bevacizumab
Irinotecan is administered every 3 weeks at a dose of 175 mg/m\^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
Irinotecan
Bevacizumab
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Irinotecan With Bevacizumab
Irinotecan is administered every 3 weeks at a dose of 175 mg/m\^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
Irinotecan
Bevacizumab
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lack of Efficacy
|
2
|
Baseline Characteristics
Irinotecan and Bevacizumab for Recurrent Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Irinotecan With Bevacizumab
n=29 Participants
Irinotecan is administered every 3 weeks at a dose of 175 mg/m\^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
Irinotecan
Bevacizumab
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
|
Number of prior regimens
|
5 Regimens
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months from the start of treatmentPopulation: Intent-to-treat population.
The PFS rate at 6 months is the percentage of patients that experience a PFS event during the first 6 months in the study. The PFS is defined as the time from date of first dose of study medication to the date of first documented disease progression, or death from any cause, whichever is first. Patients who die without a reported prior progression will be considered to have progressed on the day of their death. Progression is evaluated by Response and Evaluation Criteria in Solid Tumor (RECIST) 1.0 or CA125 criteria if no measurable disease as doubling of CA125 levels from either the upper limit of normal or the nadir CA125 level.
Outcome measures
| Measure |
Irinotecan With Bevacizumab
n=29 Participants
Irinotecan is administered every 3 weeks at a dose of 175 mg/m\^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
|
|---|---|
|
Progression Free Survival (PFS) Rate at 6 Months
|
55.2 percentage of patients
Interval 39.7 to 76.6
|
SECONDARY outcome
Timeframe: up to 3 yearsPopulation: Intent-to-treat population
ORR is defined as the percentage of all patients with confirmed partial response (PR) or complete response (CR). PR and CR are evaluated by RECIST 1.0 or CA125 if no measurable disease (PR: CA125 decreases by \> 50%; CR: CA125 decreases to the normal range).
Outcome measures
| Measure |
Irinotecan With Bevacizumab
n=29 Participants
Irinotecan is administered every 3 weeks at a dose of 175 mg/m\^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
|
|---|---|
|
Overall Response Rate (ORR)
|
27.6 percentage of patients
Interval 12.7 to 47.2
|
SECONDARY outcome
Timeframe: up to 3 yearsPopulation: Intent-to-treat
Defined as the length of time from the start of treatment that half of the patients are still alive and without disease progression. Progression is evaluated by RECIST 1.0 or CA125 if no measurable disease (PR: CA125 decreases by \> 50%; CR: CA125 decreases to the normal range; progression is defined on the basis of a confirmed doubling of CA125 levels from either the upper limit of normal or the nadir CA125 level)
Outcome measures
| Measure |
Irinotecan With Bevacizumab
n=29 Participants
Irinotecan is administered every 3 weeks at a dose of 175 mg/m\^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
|
|---|---|
|
Median Progression Free Survival
|
6.8 months
Interval 5.1 to 12.1
|
SECONDARY outcome
Timeframe: up to 3 yearsPopulation: Intent-to-treat
Defined as the length of time from the start of treatment that half of the patients are still alive.
Outcome measures
| Measure |
Irinotecan With Bevacizumab
n=29 Participants
Irinotecan is administered every 3 weeks at a dose of 175 mg/m\^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
|
|---|---|
|
Median Overall Survival
|
15.4 months
Interval 11.9 to 20.4
|
SECONDARY outcome
Timeframe: up to 3 yearsPopulation: Any patients who had at least one dose of treatment
Outcome measures
| Measure |
Irinotecan With Bevacizumab
n=29 Participants
Irinotecan is administered every 3 weeks at a dose of 175 mg/m\^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
|
|---|---|
|
Number of Patients Who Experienced Grade 3 and Higher Toxicities
Diarrhea
|
5 participants
|
|
Number of Patients Who Experienced Grade 3 and Higher Toxicities
Fatigue
|
3 participants
|
|
Number of Patients Who Experienced Grade 3 and Higher Toxicities
Pain
|
3 participants
|
|
Number of Patients Who Experienced Grade 3 and Higher Toxicities
Hypertension
|
2 participants
|
|
Number of Patients Who Experienced Grade 3 and Higher Toxicities
Nausea
|
2 participants
|
|
Number of Patients Who Experienced Grade 3 and Higher Toxicities
Proteinuria
|
2 participants
|
|
Number of Patients Who Experienced Grade 3 and Higher Toxicities
Vomiting
|
2 participants
|
|
Number of Patients Who Experienced Grade 3 and Higher Toxicities
Febrile neutropenia
|
1 participants
|
|
Number of Patients Who Experienced Grade 3 and Higher Toxicities
GI obstruction: colon
|
1 participants
|
|
Number of Patients Who Experienced Grade 3 and Higher Toxicities
GI perforation
|
1 participants
|
|
Number of Patients Who Experienced Grade 3 and Higher Toxicities
Leukopenia
|
1 participants
|
Adverse Events
Irinotecan With Bevacizumab
Serious events: 9 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Irinotecan With Bevacizumab
n=29 participants at risk
Irinotecan is administered every 3 weeks at a dose of 175 mg/m\^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
|
|---|---|
|
Gastrointestinal disorders
Pain: Abdomen NOS
|
6.9%
2/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Colitis
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Obstruction, GI: Colon
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Perforation, GI: Colon
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Nervous system disorders
Seizure
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Dehydration
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Diarrhea
|
10.3%
3/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Hepatobiliary disorders
Hemorrhage, GI: Liver
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Cardiac disorders
Hypertension
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Investigations
Leukocytes (total WBC)
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other: hydronephrosis
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
Other adverse events
| Measure |
Irinotecan With Bevacizumab
n=29 participants at risk
Irinotecan is administered every 3 weeks at a dose of 175 mg/m\^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
|
|---|---|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
10.3%
3/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Pain: Abdomen NOS
|
24.1%
7/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Nervous system disorders
Neuropathy: cranial: CN XI Motor-sternomastoid and trapezius
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
6.9%
2/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
6.9%
2/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
24.1%
7/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Anorexia
|
27.6%
8/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Psychiatric disorders
Mood alteration: Anxiety
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain: Joint
|
10.3%
3/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
10.3%
3/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain: Back
|
17.2%
5/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Metabolism and nutrition disorders
Creatinine
|
6.9%
2/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain: Bone
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Reproductive system and breast disorders
Pain: Breast
|
6.9%
2/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Bronchus
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Hemorrhage, GI: Colon
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Constipation:
|
17.2%
5/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
2/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Dehydration
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Psychiatric disorders
Mood alteration: Depression
|
10.3%
3/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Diarrhea
|
65.5%
19/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Nervous system disorders
Dizziness
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Eye disorders
Dry eye syndrome
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
10.3%
3/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
17.2%
5/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia):
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory: Nose
|
6.9%
2/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Psychiatric disorders
Mood alteration: Euphoria
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
General disorders
Pain: Face
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
55.2%
16/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Flatulence
|
6.9%
2/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Vascular disorders
Flushing
|
6.9%
2/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
6.9%
2/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Vascular disorders
Hematoma
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
24.1%
7/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Nervous system disorders
Pain: Head/headache
|
31.0%
9/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
10.3%
3/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Cardiac disorders
Hypertension
|
34.5%
10/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
6.9%
2/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
General disorders
Hypothermia
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
General disorders
Flu-like syndrome
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
13.8%
4/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Investigations
Leukocytes (total WBC)
|
17.2%
5/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Investigations
Lymphopenia
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Nervous system disorders
Memory impairment
|
10.3%
3/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy): Whole body/generalized
|
6.9%
2/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain: Muscle
|
10.3%
3/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Nausea
|
65.5%
19/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain: Neck
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
6.9%
2/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain: Extremity-limb
|
10.3%
3/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
General disorders
Pain: Pain NOS
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Reproductive system and breast disorders
Pain: Pelvis
|
10.3%
3/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Nervous system disorders
Neuropathy: sensory
|
10.3%
3/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pain: Throat/pharynx/larynx
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Investigations
Platelets
|
20.7%
6/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory: Pleura
|
6.9%
2/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Lung (pneumonia)
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Metabolism and nutrition disorders
Proteinuria
|
10.3%
3/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Investigations
INR (International Normalized Ratio of prothrombin time)
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
6.9%
2/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
10.3%
3/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
10.3%
3/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
General disorders
Rigors/chills
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Salivary gland changes/saliva
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Skin (cellulitis)
|
6.9%
2/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic): Oral cavity
|
13.8%
4/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
General disorders
Sweating (diaphoresis)
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Dental: teeth
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Pain: Dental/teeth/peridontal
|
13.8%
4/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Renal and urinary disorders
Pain: Urethra
|
13.8%
4/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Urinary tract NOS
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Reproductive system and breast disorders
Vaginal discharge (non-infectious)
|
6.9%
2/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Eye disorders
Vision-blurred vision
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Vomiting
|
55.2%
16/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
General disorders
Weight loss
|
13.8%
4/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Investigations
Alkaline phosphatase
|
6.9%
2/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Immune system disorders
Allergic reaction
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Gastrointestinal- Other: increased salivation
|
6.9%
2/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: skin sensitivity
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Hemorrhage, GI: oral cavity
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Infections and infestations
Infection - Other: Peritoneal Herpes Simplex
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other: cramping hands
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Eye disorders
Ocular/Visual - Other: visual changes
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Gastrointestinal disorders
Pain: rectum
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity//paranasal sinus reactions
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
General disorders
Edema: limb
|
6.9%
2/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory: nose
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Infections and infestations
Infection with unknown ANC: UTI
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pain: sinus
|
3.4%
1/29 • The adverse events (AEs) are collected from the start of the treatment till 30 days off treatment.
All AEs regardless of attribution are reported.
|
Additional Information
Franco Muggia, MD
Perlmutter Cancer Center at NYU Lagone
Phone: 212-263-6485
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place