Trial Outcomes & Findings for Sequential Angiogenic Blockade for the Treatment of Recurrent Mullerian Malignancies (NCT NCT00856180)
NCT ID: NCT00856180
Last Updated: 2018-09-10
Results Overview
The therapy completion rate is defined as the proportion of participants who completed at least 3 months/4 cycles of therapy. Participants were treated until disease progression on the combination regimen or unacceptable toxicity. Clinical response was evaluated based on RECIST 1.0 criteria for measurable disease (MD) participants and Gynecologic Cancer Intergroup (GCIG) CA-125 (Rustin) criteria for non-MD participants. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Serologic PD is rise in CA-125 or previously normal CA125 that rises to \>/=2xULN documented, both requiring 2nd confirmation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Serologic and radiologic disease assessments occurred every 2 cycles/6 weeks on treatment. Median treatment duration for this study cohort was 7.5 months (range 0.7-20.7).
Results posted on
2018-09-10
Participant Flow
20 patients were enrolled between March 2009 and October 2009.
Participant milestones
| Measure |
Bevacizumab Then Cyclophosphamide With Bevacizumab
Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) \[RECIST 1.0 or Rustin criteria\] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Bevacizumab Then Cyclophosphamide With Bevacizumab
Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) \[RECIST 1.0 or Rustin criteria\] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
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|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Progressive Disease
|
16
|
Baseline Characteristics
Sequential Angiogenic Blockade for the Treatment of Recurrent Mullerian Malignancies
Baseline characteristics by cohort
| Measure |
Bevacizumab Then Cyclophosphamide With Bevacizumab
n=20 Participants
Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) \[RECIST 1.0 or Rustin criteria\] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
|
|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Serologic and radiologic disease assessments occurred every 2 cycles/6 weeks on treatment. Median treatment duration for this study cohort was 7.5 months (range 0.7-20.7).Population: The analysis dataset is comprised of all treated participants.
The therapy completion rate is defined as the proportion of participants who completed at least 3 months/4 cycles of therapy. Participants were treated until disease progression on the combination regimen or unacceptable toxicity. Clinical response was evaluated based on RECIST 1.0 criteria for measurable disease (MD) participants and Gynecologic Cancer Intergroup (GCIG) CA-125 (Rustin) criteria for non-MD participants. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Serologic PD is rise in CA-125 or previously normal CA125 that rises to \>/=2xULN documented, both requiring 2nd confirmation.
Outcome measures
| Measure |
Bevacizumab Then Cyclophosphamide With Bevacizumab
n=20 Participants
Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) \[RECIST 1.0 or Rustin criteria\] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
|
Platinum Resistant
At baseline, participants were classified as platinum sensitive or platinum resistant. Platinum resisistant is defined as having had a \</=6 month interval since last receiving platinum therapy prior to disease recurrence.
|
|---|---|---|
|
Therapy Completion Rate
|
.75 proportion of participants
Interval 0.59 to 0.88
|
—
|
PRIMARY outcome
Timeframe: Assessed each cycle/3 weeks throughout treatment from time of first dose and up to day 30 post-treatment. Median treatment duration for this study cohort was 7.5 months (range 0.7-20.7).Population: The analysis dataset is comprised of all treated participants.
All grade 3-5 gastrointestinal perforation events based on CTCAEv3 as reported on case report forms.
Outcome measures
| Measure |
Bevacizumab Then Cyclophosphamide With Bevacizumab
n=20 Participants
Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) \[RECIST 1.0 or Rustin criteria\] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
|
Platinum Resistant
At baseline, participants were classified as platinum sensitive or platinum resistant. Platinum resisistant is defined as having had a \</=6 month interval since last receiving platinum therapy prior to disease recurrence.
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|---|---|---|
|
Grade 3-5 Gastrointestinal Perforation
|
0.05 proportion of participants
Interval 0.003 to 0.22
|
—
|
SECONDARY outcome
Timeframe: Radiologic disease assessments occurred every 2 cycles/6 weeks on treatment. Median treatment duration for this study cohort was 7.5 months (range 0.7-20.7).Population: The analysis dataset is comprised of all treated participants.
Clinical benefit response rate is defined as the proportion of participants who achieve confirmed stable disease (SD) or better on treatment based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Bevacizumab Then Cyclophosphamide With Bevacizumab
n=6 Participants
Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) \[RECIST 1.0 or Rustin criteria\] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
|
Platinum Resistant
n=14 Participants
At baseline, participants were classified as platinum sensitive or platinum resistant. Platinum resisistant is defined as having had a \</=6 month interval since last receiving platinum therapy prior to disease recurrence.
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|---|---|---|
|
Clinical Benefit Response Rate
|
1.00 proportion of participants
Interval 0.61 to 1.0
|
0.64 proportion of participants
Interval 0.39 to 0.85
|
SECONDARY outcome
Timeframe: Radiologic disease assessments occurred every 2 cycles/6 weeks on treatment and every 3 months in follow-up until PD, death or lost to follow-up. Median treatment duration was 7.5 months (range 0.7-20.7) and survival follow-up 23 months..Population: The analysis dataset is comprised of all treated participants.
PFS estimated using Kaplan-Meier methods is defined as the duration of time from the start of bevacizumab alone to documented disease progression (PD) requiring removal from the study or death. If participant ultimately received both bevacizumab and cyclophosphamide then it was the time until PD on both agents. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Serologic PD is rise in CA-125 or previously normal CA-125 that rises to \>/=2xULN documented, both requiring 2nd confirmation. Participants who were event-free were censored at the date of their last disease evaluation.
Outcome measures
| Measure |
Bevacizumab Then Cyclophosphamide With Bevacizumab
n=20 Participants
Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) \[RECIST 1.0 or Rustin criteria\] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
|
Platinum Resistant
At baseline, participants were classified as platinum sensitive or platinum resistant. Platinum resisistant is defined as having had a \</=6 month interval since last receiving platinum therapy prior to disease recurrence.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
8.41 months
Interval 2.83 to 15.41
|
—
|
SECONDARY outcome
Timeframe: Participants were followed long-term for survival every 3 months from the end of treatment until death or lost to follow-up. Median follow-up was 23 months in this study cohort.Population: The analysis dataset is comprised of all treated participants.
OS estimated using Kaplan-Meier methods is defined as the time from study entry to death or date last known alive.
Outcome measures
| Measure |
Bevacizumab Then Cyclophosphamide With Bevacizumab
n=20 Participants
Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) \[RECIST 1.0 or Rustin criteria\] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
|
Platinum Resistant
At baseline, participants were classified as platinum sensitive or platinum resistant. Platinum resisistant is defined as having had a \</=6 month interval since last receiving platinum therapy prior to disease recurrence.
|
|---|---|---|
|
Overall Survival (OS)
|
22.72 months
Interval 15.44 to 30.95
|
—
|
Adverse Events
Bevacizumab Then Cyclophosphamide With Bevacizumab
Serious events: 14 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab Then Cyclophosphamide With Bevacizumab
n=20 participants at risk
Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) \[RECIST 1.0 or Rustin criteria\] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
|
|---|---|
|
Cardiac disorders
Cardiac-ischemia
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Obstruction, colon
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Fatigue
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Head/headache
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Vascular disorders
Hypertension
|
60.0%
12/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
Other adverse events
| Measure |
Bevacizumab Then Cyclophosphamide With Bevacizumab
n=20 participants at risk
Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) \[RECIST 1.0 or Rustin criteria\] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
|
|---|---|
|
Infections and infestations
Infection Gr0-2 neut, upper airway
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Cardiac disorders
Cardiac-other
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Eye disorders
Dry eye syndrome
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Eye disorders
Eye, pain
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
5/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
25.0%
5/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Enteritis
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Dyspepsia
|
15.0%
3/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
8/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Abdomen, pain
|
10.0%
2/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Stomach, pain
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Fatigue
|
80.0%
16/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Edema head and neck
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Edema limb
|
10.0%
2/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Leukocytes
|
15.0%
3/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Neutrophils
|
15.0%
3/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Platelets
|
10.0%
2/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
ALT, SGPT
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
AST, SGOT
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
35.0%
7/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Joint-function
|
10.0%
2/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
15.0%
3/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
10.0%
2/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
40.0%
8/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
15.0%
3/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Neck, pain
|
15.0%
3/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Head/headache
|
30.0%
6/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Renal and urinary disorders
Urinary hemorrhage NOS
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Renal and urinary disorders
Proteinuria
|
20.0%
4/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Reproductive system and breast disorders
Vagina, hemorrhage
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
20.0%
4/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.0%
3/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reaction
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
15.0%
3/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
15.0%
3/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Vascular disorders
Hot flashes
|
5.0%
1/20 • Assessed each cycle/ 3 weeks throughout treatment from time of first dose and up to day 30 post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place