Trial Outcomes & Findings for Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery (NCT NCT01533207)
NCT ID: NCT01533207
Last Updated: 2020-04-28
Results Overview
The duration of time from study entry to time of death or the date of last contact.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
38 participants
Primary outcome timeframe
Follow-up every 4 months for 3 years, then every 6 months for 2 years.
Results posted on
2020-04-28
Participant Flow
This study accrued 38 patients from June 2012 to September, 2016. Study was closed due to accrual futility.
Participant milestones
| Measure |
Regimen 1
Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles
|
Regimen II
Observation
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
18
|
|
Overall Study
COMPLETED
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery
Baseline characteristics by cohort
| Measure |
Regimen 1
n=20 Participants
Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles
|
Regimen II
n=18 Participants
Observation
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
20-29 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Follow-up every 4 months for 3 years, then every 6 months for 2 years.Population: Eligible and evaluable participants
The duration of time from study entry to time of death or the date of last contact.
Outcome measures
| Measure |
Regimen 1
n=20 Participants
Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles
|
Regimen II
n=18 Participants
Observation
|
|---|---|---|
|
Number of Participants Who Experienced Death
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Approximately 4 yearsPopulation: eligible and randomized patients
Outcome measures
| Measure |
Regimen 1
n=20 Participants
Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles
|
Regimen II
n=18 Participants
Observation
|
|---|---|---|
|
Incidence of Grade 3 or Higher Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
|
10 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Follow-up every 4 months for 3 years, then every 6 months for 2 years.Population: Eligible and evaluable participants
The duration of time from study entry to time of recurrence or death, whichever occurred first, or the date of last contact.
Outcome measures
| Measure |
Regimen 1
n=20 Participants
Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles
|
Regimen II
n=18 Participants
Observation
|
|---|---|---|
|
Number of Participants With Recurrence
|
8 participants
|
8 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsAnalyses will be carried out using proportional hazards models of both survival and recurrence.
Outcome measures
Outcome data not reported
Adverse Events
Regimen 1
Serious events: 5 serious events
Other events: 16 other events
Deaths: 5 deaths
Regimen II
Serious events: 0 serious events
Other events: 12 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Regimen 1
n=20 participants at risk
Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles
|
Regimen II
n=18 participants at risk
Observation
|
|---|---|---|
|
Gastrointestinal disorders
Mucositis Oral
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Infections and infestations
Wound Infection
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Infections and infestations
Skin Infection
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Infections and infestations
Catheter Related Infection
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Injury, poisoning and procedural complications
Vascular Access Complication
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Investigations
Neutrophil Count Decreased
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
Other adverse events
| Measure |
Regimen 1
n=20 participants at risk
Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles
|
Regimen II
n=18 participants at risk
Observation
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Blood and lymphatic system disorders
Blood And Lymphatic System Disorders - Other
|
15.0%
3/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Blood and lymphatic system disorders
Anemia
|
65.0%
13/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Cardiac disorders
Atrial Fibrillation
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Cardiac disorders
Palpitations
|
20.0%
4/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Cardiac disorders
Chest Pain - Cardiac
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Ear and labyrinth disorders
Hearing Impaired
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Ear and labyrinth disorders
Ear Pain
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Eye disorders
Watering Eyes
|
10.0%
2/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Eye disorders
Blurred Vision
|
10.0%
2/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
2/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Gastrointestinal disorders
Constipation
|
30.0%
6/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Gastrointestinal disorders
Diarrhea
|
35.0%
7/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
4/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Gastrointestinal disorders
Bloating
|
10.0%
2/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Gastrointestinal disorders
Anal Hemorrhage
|
0.00%
0/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Gastrointestinal disorders
Abdominal Pain
|
20.0%
4/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
22.2%
4/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Gastrointestinal disorders
Mucositis Oral
|
25.0%
5/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Gastrointestinal disorders
Lower Gastrointestinal Hemorrhage
|
0.00%
0/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other
|
0.00%
0/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Gastrointestinal disorders
Oral Pain
|
10.0%
2/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Gastrointestinal disorders
Nausea
|
60.0%
12/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Gastrointestinal disorders
Hemorrhoidal Hemorrhage
|
0.00%
0/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Gastrointestinal disorders
Toothache
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
General disorders
General Disorders And Administration Site Conditio
|
0.00%
0/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
General disorders
Pain
|
10.0%
2/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
General disorders
Malaise
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
General disorders
Non-Cardiac Chest Pain
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
General disorders
Edema Limbs
|
35.0%
7/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
11.1%
2/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
General disorders
Fatigue
|
70.0%
14/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
27.8%
5/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
General disorders
Fever
|
30.0%
6/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
General disorders
Chills
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
General disorders
Infusion Related Reaction
|
10.0%
2/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Infections and infestations
Infections And Infestations - Other
|
10.0%
2/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Infections and infestations
Upper Respiratory Infection
|
10.0%
2/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Infections and infestations
Tooth Infection
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Infections and infestations
Skin Infection
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Infections and infestations
Lung Infection
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Infections and infestations
Phlebitis Infective
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Infections and infestations
Urinary Tract Infection
|
10.0%
2/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Investigations
Weight Gain
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Investigations
Platelet Count Decreased
|
35.0%
7/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Investigations
Creatinine Increased
|
10.0%
2/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Investigations
Neutrophil Count Decreased
|
40.0%
8/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Investigations
White Blood Cell Decreased
|
35.0%
7/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Investigations
Aspartate Aminotransferase Increased
|
20.0%
4/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Investigations
Alkaline Phosphatase Increased
|
15.0%
3/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Investigations
Alanine Aminotransferase Increased
|
25.0%
5/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Metabolism and nutrition disorders
Metabolism And Nutrition Disorders - Other
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
2/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.0%
3/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
4/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
4/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
10.0%
2/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
4/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
5/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
15.0%
3/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.0%
3/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
0.00%
0/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Musculoskeletal and connective tissue disorders
Buttock Pain
|
0.00%
0/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
10.0%
2/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.0%
3/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Nervous system disorders
Nervous System Disorders - Other
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
25.0%
5/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Nervous system disorders
Paresthesia
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Nervous system disorders
Headache
|
20.0%
4/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
16.7%
3/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Nervous system disorders
Dysgeusia
|
10.0%
2/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Nervous system disorders
Syncope
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Nervous system disorders
Dizziness
|
15.0%
3/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Nervous system disorders
Akathisia
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Psychiatric disorders
Personality Change
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Psychiatric disorders
Insomnia
|
20.0%
4/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Psychiatric disorders
Depression
|
15.0%
3/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
11.1%
2/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Psychiatric disorders
Anxiety
|
15.0%
3/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
16.7%
3/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Renal and urinary disorders
Urine Discoloration
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Renal and urinary disorders
Urinary Urgency
|
0.00%
0/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Renal and urinary disorders
Urinary Incontinence
|
10.0%
2/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Renal and urinary disorders
Urinary Tract Pain
|
0.00%
0/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Renal and urinary disorders
Urinary Frequency
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Renal and urinary disorders
Proteinuria
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Renal and urinary disorders
Hematuria
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
0.00%
0/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Reproductive system and breast disorders
Vaginal Inflammation
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic And Mediastinal Disorders -
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
25.0%
5/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
30.0%
6/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
3/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other
|
10.0%
2/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Skin and subcutaneous tissue disorders
Scalp Pain
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
15.0%
3/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
55.0%
11/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Surgical and medical procedures
Surgical And Medical Procedures - Other
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Vascular disorders
Thromboembolic Event
|
15.0%
3/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Vascular disorders
Superficial Thrombophlebitis
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
0.00%
0/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Vascular disorders
Hypertension
|
10.0%
2/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
11.1%
2/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Vascular disorders
Hot Flashes
|
20.0%
4/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
22.2%
4/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
|
Vascular disorders
Flushing
|
5.0%
1/20 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
5.6%
1/18 • For Regimen 1: Baseline (pre-treatment); Prior to each cycle of chemotherapy, up to 4 months. For Regimen 2: Every 3-4 weeks for months 1-3. Every 3-4 weeks for months 3-6 on study.
|
Additional Information
Linda Gedeon on behalf of Danielle Enserro, PhD
NRG Oncology
Phone: 716-845-1169
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60