Trial Outcomes & Findings for Phase I/II Study of Weekly Abraxane and RAD001 in Women With Locally Adv. or Metastatic Breast Ca (NCT NCT00934895)
NCT ID: NCT00934895
Last Updated: 2023-09-18
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
5 yrs
Results posted on
2023-09-18
Participant Flow
Subjects were recruited through the Rutgers Cancer Institute of New Jersey Oncology Group. They study was open to accrual on 07/15/2009 and closed to accrual on 01/07/2014.
We are reporting results on 27 eligible patients. One patient was deemed ineligible.
Participant milestones
| Measure |
Phase I Level -1 - RAD001 5mg Daily, Abraxane 60mg/m2
Phase I:
* Abraxane 60 mg/m2 will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
* RAD001 will be given by tablet (5 mg). The first group of patients will receive RAD001every day depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
|
Phase 1 Level -2 - RAD001 5mg Every Other Day, Abraxane 60mg/m2
Phase I:
* Abraxane 60 mg/m2 will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
* RAD001 will be given by tablet (5 mg). The first group of patients will receive RAD001every other day depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
|
Phase 1 Level 0 RAD001 5mg Daily, Abraxane 80mg/m2
Phase I:
* Abraxane 80 mg/m2 will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
* RAD001 will be given by tablet (5 mg). The first group of patients will receive RAD001 every day depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
|
Phase 1 Level 1 RAD001 5mg Daily, Abraxane 100mg/m2
Phase I:
* Abraxane 100 mg/m2 will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
* RAD001 will be given by tablet (5 mg). The first group of patients will receive RAD001 every day depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
|
Phase 1 Level 2 RAD001 5mg Daily, Abraxane 125mg/m2
Phase I:
* Abraxane 125 mg/m2 will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
* RAD001 will be given by tablet (5 mg). The first group of patients will receive RAD001 every day depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
|
Phase 1 Level 3 RAD001 10mg Daily, Abraxane 125mg/m2
Phase I:
* Abraxane 125 mg/m2 will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
* RAD001 will be given by tablet (10 mg) daily. The first group of patients will receive RAD001 every day depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
|
Phase II Abraxane at 150 mg/m2
The Phase II treatment schedule will continue following the same 28 day cycle schedule as Phase I.
Abraxane will be administered without premedication as a 30 minute intravenous infusion weekly for the first 3 of the 4 weeks of a 28 day cycle (Day 1, Day 8, and Day 15 of each cycle). The dose of Abraxane to be used in the Phase II portion of the trial will be based upon the MTD established in the Phase I portion of this trial.
RAD001 will be administered on the schedule and at the maximum tolerated dose as determined by the Phase I results.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
3
|
6
|
4
|
0
|
14
|
|
Overall Study
COMPLETED
|
0
|
0
|
3
|
6
|
4
|
0
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I/II Study of Weekly Abraxane and RAD001 in Women With Locally Adv. or Metastatic Breast Ca
Baseline characteristics by cohort
| Measure |
Phase I Level -1 - RAD001 5mg Daily, Abraxane 60mg/m2
Phase I:
* Abraxane 60 mg/m2 will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
* RAD001 will be given by tablet (5 mg). The first group of patients will receive RAD001every day depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
|
Phase 1 Level -2 - RAD001 5mg Every Other Day, Abraxane 60mg/m2
Phase I:
* Abraxane 60 mg/m2 will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
* RAD001 will be given by tablet (5 mg). The first group of patients will receive RAD001every other day depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
|
Phase 1 Level 0 RAD001 5mg Daily, Abraxane 80mg/m2
n=3 Participants
Phase I:
* Abraxane 80 mg/m2 will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
* RAD001 will be given by tablet (5 mg). The first group of patients will receive RAD001 every day depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
|
Phase 1 Level 1 RAD001 5mg Daily, Abraxane 100mg/m2
n=6 Participants
Phase I:
* Abraxane 100 mg/m2 will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
* RAD001 will be given by tablet (5 mg). The first group of patients will receive RAD001 every day depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
|
Phase 1 Level 2 RAD001 5mg Daily, Abraxane 125mg/m2
n=4 Participants
Phase I:
* Abraxane 125 mg/m2 will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
* RAD001 will be given by tablet (5 mg). The first group of patients will receive RAD001 every day depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
|
Phase 1 Level 3 RAD001 10mg Daily, Abraxane 125mg/m2
Phase I:
* Abraxane 125 mg/m2 will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
* RAD001 will be given by tablet (10 mg) daily. The first group of patients will receive RAD001 every day depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
|
Phase II
n=14 Participants
Phase II:
The maximum tolerated dose (established in Phase I) will be given as scheduled below and we will measure the effectiveness of the study drug combination.
* Abraxane will be given by IV (intravenous infusion) for 30 minutes on the first day of the first three weeks of each 28 day cycle (Day 1, Day 8, and Day 15 of each cycle).
* RAD001 will be given by tablet based on the dose established in the Phase I part of the study.
everolimus: Orally administered RAD001 will be initiated at 5 mg daily. Each cohort Phase I: administration will proceed based on escalation criteria. RAD001
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
16 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
11 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
27 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
26 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
7 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
16 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
—
|
—
|
3 participants
n=27 Participants
|
6 participants
n=483 Participants
|
4 participants
n=36 Participants
|
—
|
14 participants
n=115 Participants
|
27 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 5 yrsOutcome measures
| Measure |
All Participants
n=27 Participants
Phase I:
* Abraxane will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
* RAD001 will be given by tablet. The first group of patients will receive RAD001 once daily depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
Phase II:
The maximum tolerated dose (established in Phase I) will be given as scheduled below and we will measure the effectiveness of the study drug combination.
* Abraxane will be given by IV (intravenous infusion) for 30 minutes on the first day of the first three weeks of each 28 day cycle (Day 1, Day 8, and Day 15 of each cycle).
* RAD001 will be given by tablet based on the dose established in the Phase I part of the study.
everolimus: Orally administered RAD001 will be initiated at 5 mg daily. Each cohort Phase I: administration will proceed based on escalation criteria. RAD001
|
|---|---|
|
To Determine the Maximum Tolerated Dose (MTD) of RAD001 in Combination of Weekly Abraxane and Determine the Phase II Dose of RAD001.
|
5 mg
|
Adverse Events
Phase I Level -1 - RAD001 5mg Daily, Abraxane 60mg/m2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1 Level -2 - RAD001 5mg Every Other Day, Abraxane 60mg/m2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1 Level 0 RAD001 5mg Daily, Abraxane 80mg/m2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 3 deaths
Phase 1 Level 1 RAD001 5mg Daily, Abraxane 100mg/m2
Serious events: 2 serious events
Other events: 6 other events
Deaths: 6 deaths
Phase 1 Level 2 RAD001 5mg Daily, Abraxane 125mg/m2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 3 deaths
Phase 1 Level 3 RAD001 10mg Daily, Abraxane 125mg/m2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase II
Serious events: 4 serious events
Other events: 14 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Phase I Level -1 - RAD001 5mg Daily, Abraxane 60mg/m2
Phase I:
* Abraxane 60 mg/m2 will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
* RAD001 will be given by tablet (5 mg). The first group of patients will receive RAD001every day depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
|
Phase 1 Level -2 - RAD001 5mg Every Other Day, Abraxane 60mg/m2
Phase I:
* Abraxane 60 mg/m2 will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
* RAD001 will be given by tablet (5 mg). The first group of patients will receive RAD001every other day depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
|
Phase 1 Level 0 RAD001 5mg Daily, Abraxane 80mg/m2
n=3 participants at risk
Phase I:
* Abraxane 80 mg/m2 will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
* RAD001 will be given by tablet (5 mg). The first group of patients will receive RAD001 every day depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
|
Phase 1 Level 1 RAD001 5mg Daily, Abraxane 100mg/m2
n=6 participants at risk
Phase I:
* Abraxane 100 mg/m2 will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
* RAD001 will be given by tablet (5 mg). The first group of patients will receive RAD001 every day depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
|
Phase 1 Level 2 RAD001 5mg Daily, Abraxane 125mg/m2
n=4 participants at risk
Phase I:
* Abraxane 125 mg/m2 will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
* RAD001 will be given by tablet (5 mg). The first group of patients will receive RAD001 every day depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
|
Phase 1 Level 3 RAD001 10mg Daily, Abraxane 125mg/m2
Phase I:
* Abraxane 125 mg/m2 will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
* RAD001 will be given by tablet (10 mg) daily. The first group of patients will receive RAD001 every day depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
|
Phase II
n=14 participants at risk
Phase II:
The maximum tolerated dose (established in Phase I) will be given as scheduled below and we will measure the effectiveness of the study drug combination.
* Abraxane will be given by IV (intravenous infusion) for 30 minutes on the first day of the first three weeks of each 28 day cycle (Day 1, Day 8, and Day 15 of each cycle).
* RAD001 will be given by tablet based on the dose established in the Phase I part of the study. everolimus: Orally administered RAD001 will be initiated at 5 mg daily. Each cohort Phase I: administration will proceed based on escalation criteria. RAD001
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
16.7%
1/6 • Number of events 4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/14 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Nervous system disorders
Alaxia
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
21.4%
3/14 • Number of events 4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Infections and infestations
Infection
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/14 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/14 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
Other adverse events
| Measure |
Phase I Level -1 - RAD001 5mg Daily, Abraxane 60mg/m2
Phase I:
* Abraxane 60 mg/m2 will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
* RAD001 will be given by tablet (5 mg). The first group of patients will receive RAD001every day depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
|
Phase 1 Level -2 - RAD001 5mg Every Other Day, Abraxane 60mg/m2
Phase I:
* Abraxane 60 mg/m2 will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
* RAD001 will be given by tablet (5 mg). The first group of patients will receive RAD001every other day depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
|
Phase 1 Level 0 RAD001 5mg Daily, Abraxane 80mg/m2
n=3 participants at risk
Phase I:
* Abraxane 80 mg/m2 will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
* RAD001 will be given by tablet (5 mg). The first group of patients will receive RAD001 every day depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
|
Phase 1 Level 1 RAD001 5mg Daily, Abraxane 100mg/m2
n=6 participants at risk
Phase I:
* Abraxane 100 mg/m2 will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
* RAD001 will be given by tablet (5 mg). The first group of patients will receive RAD001 every day depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
|
Phase 1 Level 2 RAD001 5mg Daily, Abraxane 125mg/m2
n=4 participants at risk
Phase I:
* Abraxane 125 mg/m2 will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
* RAD001 will be given by tablet (5 mg). The first group of patients will receive RAD001 every day depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
|
Phase 1 Level 3 RAD001 10mg Daily, Abraxane 125mg/m2
Phase I:
* Abraxane 125 mg/m2 will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle.
* RAD001 will be given by tablet (10 mg) daily. The first group of patients will receive RAD001 every day depending on side effects seen drug could be increased later to twice a day for a 28 day cycle.
Once a safe and effective drug range is established, the study moves into Phase II.
|
Phase II
n=14 participants at risk
Phase II:
The maximum tolerated dose (established in Phase I) will be given as scheduled below and we will measure the effectiveness of the study drug combination.
* Abraxane will be given by IV (intravenous infusion) for 30 minutes on the first day of the first three weeks of each 28 day cycle (Day 1, Day 8, and Day 15 of each cycle).
* RAD001 will be given by tablet based on the dose established in the Phase I part of the study. everolimus: Orally administered RAD001 will be initiated at 5 mg daily. Each cohort Phase I: administration will proceed based on escalation criteria. RAD001
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
57.1%
8/14 • Number of events 16 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
33.3%
2/6 • Number of events 3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
50.0%
7/14 • Number of events 19 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
57.1%
8/14 • Number of events 18 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Blood and lymphatic system disorders
Platelets
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
16.7%
1/6 • Number of events 2 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
14.3%
2/14 • Number of events 5 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
71.4%
10/14 • Number of events 16 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
16.7%
1/6 • Number of events 2 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
42.9%
6/14 • Number of events 14 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
50.0%
7/14 • Number of events 8 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
42.9%
6/14 • Number of events 7 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin -
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
28.6%
4/14 • Number of events 4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
28.6%
4/14 • Number of events 5 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
21.4%
3/14 • Number of events 6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
14.3%
2/14 • Number of events 2 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Gastrointestinal disorders
Diarrhea
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
85.7%
12/14 • Number of events 43 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Gastrointestinal disorders
Constipation
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
33.3%
2/6 • Number of events 2 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
21.4%
3/14 • Number of events 3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Gastrointestinal disorders
Mucositis/stomatitis
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
33.3%
2/6 • Number of events 3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
14.3%
2/14 • Number of events 2 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
14.3%
2/14 • Number of events 2 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
21.4%
3/14 • Number of events 5 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
28.6%
4/14 • Number of events 4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholesteremia)
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
21.4%
3/14 • Number of events 3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
21.4%
3/14 • Number of events 4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
14.3%
2/14 • Number of events 2 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
14.3%
2/14 • Number of events 2 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
7.1%
1/14 • Number of events 2 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
14.3%
2/14 • Number of events 2 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
14.3%
2/14 • Number of events 2 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
21.4%
3/14 • Number of events 3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
14.3%
2/14 • Number of events 2 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Investigations
Bicarbonate, serum-low
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
14.3%
2/14 • Number of events 2 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Metabolism and nutrition disorders
Neuropathy: sensory
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
42.9%
6/14 • Number of events 6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Nervous system disorders
Dizziness
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
21.4%
3/14 • Number of events 3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Nervous system disorders
Mood alteration - Depression
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
General disorders
Pain - Back
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
14.3%
2/14 • Number of events 2 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
General disorders
Pain - Extremity-limb
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
33.3%
2/6 • Number of events 2 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
21.4%
3/14 • Number of events 3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
General disorders
Pain - Head/headache
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
21.4%
3/14 • Number of events 3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
General disorders
Pain - Abdomen NOS
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
14.3%
2/14 • Number of events 3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
General disorders
Pain - Joint
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
General disorders
Pain - Muscle
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
7.1%
1/14 • Number of events 2 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
General disorders
Pain - Dental/teeth/peridontal
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
7.1%
1/14 • Number of events 2 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
General disorders
Pain
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
General disorders
Pain - Pain NOS
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
35.7%
5/14 • Number of events 7 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
General disorders
Weight loss
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
General disorders
Insomnia
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Blood and lymphatic system disorders
Edema: limb
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
33.3%
2/6 • Number of events 2 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
42.9%
6/14 • Number of events 7 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
14.3%
2/14 • Number of events 2 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
28.6%
4/14 • Number of events 6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
21.4%
3/14 • Number of events 4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
14.3%
2/14 • Number of events 3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Infections and infestations
Infection with unknown ANC - Urinary tract NOS
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
14.3%
2/14 • Number of events 2 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Blood and lymphatic system disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
21.4%
3/14 • Number of events 4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Othe
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
14.3%
2/14 • Number of events 2 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Infections and infestations
Fever
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/14 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Nervous system disorders
Neuropathy
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/14 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Blood and lymphatic system disorders
hoarseness
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/6 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/14 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Respiratory, thoracic and mediastinal disorders
soar throat
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
33.3%
2/6 • Number of events 3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
50.0%
2/4 • Number of events 2 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/14 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Blood and lymphatic system disorders
Anemia
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
33.3%
2/6 • Number of events 2 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/14 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/14 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Gastrointestinal disorders
Nausea
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/14 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
|
Gastrointestinal disorders
Anorexia
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/3 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
33.3%
2/6 • Number of events 2 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/4 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
—
0/0 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
0.00%
0/14 • Adverse events were collected over a period of 171 days per patient.
There wer no participants in Level -1, -2 and 3.
|
Additional Information
Deborah L Toppmeyer, M.D.
Rutgers Cancer Institute of New Jersey
Phone: 732-235-6789
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place