Trial Outcomes & Findings for Platinum for Triple-Negative Metastatic Breast Cancer and Evaluation of p63/p73 as a Biomarker of Response (NCT NCT00483223)
NCT ID: NCT00483223
Last Updated: 2017-08-25
Results Overview
Objective response rate (ORR) (complete response \[CR\]+ partial response \[PR\]) by RECIST (Response Evaluation Criteria In Solid Tumors). Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD (longest diameter) of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
86 participants
Primary outcome timeframe
3 years
Results posted on
2017-08-25
Participant Flow
Participant milestones
| Measure |
Cisplatin or Carboplatin
Cisplatin or carboplatin (1 arm, 2 cohorts)
Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
|
|---|---|
|
Overall Study
STARTED
|
86
|
|
Overall Study
COMPLETED
|
86
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Platinum for Triple-Negative Metastatic Breast Cancer and Evaluation of p63/p73 as a Biomarker of Response
Baseline characteristics by cohort
| Measure |
Single Arm
n=86 Participants
Cisplatin or carboplatin (1 arm, 2 cohorts)
Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
|
|---|---|
|
Age, Continuous
|
52 years
n=5 Participants
|
|
Age, Customized
< 40
|
13 Participants
n=5 Participants
|
|
Age, Customized
40-65
|
63 Participants
n=5 Participants
|
|
Age, Customized
> 65
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
69 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
> one or other
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
86 Participants
n=5 Participants
|
|
ECOG PS
0
|
55 Participants
n=5 Participants
|
|
ECOG PS
1
|
20 Participants
n=5 Participants
|
|
ECOG PS
2
|
5 Participants
n=5 Participants
|
|
ECOG PS
Not reported
|
6 Participants
n=5 Participants
|
|
Site of metastases
Lymph nodes
|
54 participants
n=5 Participants
|
|
Site of metastases
Lung
|
44 participants
n=5 Participants
|
|
Site of metastases
Bone
|
25 participants
n=5 Participants
|
|
Site of metastases
Liver
|
25 participants
n=5 Participants
|
|
Site of metastases
Skin
|
16 participants
n=5 Participants
|
|
Site of metastases
Brain
|
4 participants
n=5 Participants
|
|
Stage at initial diagnosis of breast cancer
1
|
10 Participants
n=5 Participants
|
|
Stage at initial diagnosis of breast cancer
2
|
32 Participants
n=5 Participants
|
|
Stage at initial diagnosis of breast cancer
3
|
37 Participants
n=5 Participants
|
|
Stage at initial diagnosis of breast cancer
4
|
7 Participants
n=5 Participants
|
|
Prior chemotherapy
Adjuvant/neoadjuvant
|
74 participants
n=5 Participants
|
|
Prior chemotherapy
Anthracycline
|
65 participants
n=5 Participants
|
|
Prior chemotherapy
Taxane
|
67 participants
n=5 Participants
|
|
Treatment cohort
Cisplatin (cohort 1)
|
43 Participants
n=5 Participants
|
|
Treatment cohort
Carboplatin (cohort 2)
|
43 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsObjective response rate (ORR) (complete response \[CR\]+ partial response \[PR\]) by RECIST (Response Evaluation Criteria In Solid Tumors). Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD (longest diameter) of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Outcome measures
| Measure |
Cisplatin or Carboplatin
n=86 Participants
Cisplatin or carboplatin (1 arm, 2 cohorts)
Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
|
|---|---|
|
Objective Response Rate
Complete Response
|
3 Participants
|
|
Objective Response Rate
Partial Response
|
19 Participants
|
|
Objective Response Rate
Stable Disease > 6 Months
|
4 Participants
|
|
Objective Response Rate
Progressive Disease
|
57 Participants
|
|
Objective Response Rate
Not Evaluable
|
3 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Patients from either cohort with a tumor sample available to evaluate for expression ratio.
Response rate categorized by pre-specified ΔNp63/TAp73 expression ratio cutoff in the primary tumors from this patient cohort as a bio-marker to predict response to cisplatin or carboplatin. Response is defined as partial or completed response as determined by RECIST. Expression ratio was measured using quantitative RT-PCR (Reverse transcription polymerase chain reaction).
Outcome measures
| Measure |
Cisplatin or Carboplatin
n=61 Participants
Cisplatin or carboplatin (1 arm, 2 cohorts)
Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
|
|---|---|
|
Response Rate Categorized by p63/p73 Ratio
p63/p73 > 2 · Response
|
9 Participants
|
|
Response Rate Categorized by p63/p73 Ratio
p63/p73 > 2 · No Response
|
24 Participants
|
|
Response Rate Categorized by p63/p73 Ratio
p63/p73 < 2 · Response
|
5 Participants
|
|
Response Rate Categorized by p63/p73 Ratio
p63/p73 < 2 · No Response
|
23 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Response rate is divide by drug cohort and categorized by first or second-line treatment
The number of participants achieving an objective response (as determined by RECIST) categorized by treatment cohort and whether the treatment was first or second line treatment. First line treatment means that the drug used was the first drug used for the treatment of the primary cancer. Second line treatment means that a first line treatment failed to produce the desired response, so a new drug was used for treatment.
Outcome measures
| Measure |
Cisplatin or Carboplatin
n=86 Participants
Cisplatin or carboplatin (1 arm, 2 cohorts)
Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
|
|---|---|
|
Objective Response Rate Categorized by Subgroup
Cisplatin · First line: Response
|
12 Participants
|
|
Objective Response Rate Categorized by Subgroup
Cisplatin · First line: No response
|
22 Participants
|
|
Objective Response Rate Categorized by Subgroup
Cisplatin · Second line: Response
|
2 Participants
|
|
Objective Response Rate Categorized by Subgroup
Cisplatin · Second line: No response
|
7 Participants
|
|
Objective Response Rate Categorized by Subgroup
Carboplatin · First line: Response
|
8 Participants
|
|
Objective Response Rate Categorized by Subgroup
Carboplatin · First line: No response
|
27 Participants
|
|
Objective Response Rate Categorized by Subgroup
Carboplatin · Second line: Response
|
0 Participants
|
|
Objective Response Rate Categorized by Subgroup
Carboplatin · Second line: No response
|
8 Participants
|
SECONDARY outcome
Timeframe: 5 yearsMedian progression free survival and overall survival (progression determined using RECIST) during a median follow-up time of 50 months.
Outcome measures
| Measure |
Cisplatin or Carboplatin
n=86 Participants
Cisplatin or carboplatin (1 arm, 2 cohorts)
Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
|
|---|---|
|
Progression Free Survival and Overall Survival
Median Progression Free Survival
|
2.9 Months
Interval 0.1 to 56.8
|
|
Progression Free Survival and Overall Survival
Median Overall Survival
|
11 Months
Interval 1.6 to 56.8
|
Adverse Events
Cisplatin or Carboplatin
Serious events: 8 serious events
Other events: 85 other events
Deaths: 75 deaths
Serious adverse events
| Measure |
Cisplatin or Carboplatin
n=86 participants at risk
Cisplatin or carboplatin (1 arm, 2 cohorts)
Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
|
|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.2%
1/86 • Number of events 1 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Vascular disorders
Hypertension
|
1.2%
1/86 • Number of events 1 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Investigations
Neutrophil Count
|
1.2%
1/86 • Number of events 1 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Infections and infestations
Infection with normal ANC
|
4.7%
4/86 • Number of events 4 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
General disorders
Hypersensitivity reaction to Cisplatin
|
1.2%
1/86 • Number of events 1 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
Other adverse events
| Measure |
Cisplatin or Carboplatin
n=86 participants at risk
Cisplatin or carboplatin (1 arm, 2 cohorts)
Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.
|
|---|---|
|
Immune system disorders
Allergic reaction
|
4.7%
4/86 • Number of events 7 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Ear and labyrinth disorders
Tinnitus
|
18.6%
16/86 • Number of events 34 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Investigations
Hemoglobin
|
73.3%
63/86 • Number of events 250 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Investigations
Leukocytes
|
39.5%
34/86 • Number of events 97 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Investigations
Lymphopenia
|
23.3%
20/86 • Number of events 71 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Investigations
Neutrophils
|
40.7%
35/86 • Number of events 75 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Investigations
Platelets
|
32.6%
28/86 • Number of events 72 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
General disorders
Fatigue
|
66.3%
57/86 • Number of events 217 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
General disorders
Fever w/o neutropenia
|
9.3%
8/86 • Number of events 8 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Psychiatric disorders
Insomnia
|
11.6%
10/86 • Number of events 35 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
General disorders
Constitutional, other
|
8.1%
7/86 • Number of events 7 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.0%
6/86 • Number of events 12 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
4.7%
4/86 • Number of events 10 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
10.5%
9/86 • Number of events 17 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Vascular disorders
Hot flashes
|
9.3%
8/86 • Number of events 25 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Metabolism and nutrition disorders
Anorexia
|
17.4%
15/86 • Number of events 22 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Gastrointestinal disorders
Constipation
|
30.2%
26/86 • Number of events 61 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
10.5%
9/86 • Number of events 13 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Gastrointestinal disorders
Nausea
|
66.3%
57/86 • Number of events 143 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Gastrointestinal disorders
Vomiting
|
18.6%
16/86 • Number of events 29 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Gastrointestinal disorders
GI-other
|
7.0%
6/86 • Number of events 9 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.8%
11/86 • Number of events 21 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
General disorders
Edema limb
|
11.6%
10/86 • Number of events 19 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.6%
10/86 • Number of events 14 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
22.1%
19/86 • Number of events 51 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Metabolism and nutrition disorders
ALT, SGPT
|
18.6%
16/86 • Number of events 28 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Metabolism and nutrition disorders
AST, SGOT
|
29.1%
25/86 • Number of events 51 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.0%
12/86 • Number of events 14 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
45.3%
39/86 • Number of events 79 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
32.6%
28/86 • Number of events 105 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.5%
9/86 • Number of events 19 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
17.4%
15/86 • Number of events 27 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Nervous system disorders
Dizziness
|
11.6%
10/86 • Number of events 14 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Psychiatric disorders
Anxiety
|
9.3%
8/86 • Number of events 19 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Psychiatric disorders
Depression
|
4.7%
4/86 • Number of events 7 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Nervous system disorders
Neuropathy-sensory
|
37.2%
32/86 • Number of events 114 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Nervous system disorders
Neuropathy-peripheral
|
5.8%
5/86 • Number of events 10 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Nervous system disorders
Neurologic-other
|
5.8%
5/86 • Number of events 8 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Gastrointestinal disorders
Abdomen, pain
|
10.5%
9/86 • Number of events 11 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
12.8%
11/86 • Number of events 20 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Musculoskeletal and connective tissue disorders
Bone, pain
|
7.0%
6/86 • Number of events 10 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Musculoskeletal and connective tissue disorders
Chest wall, pain
|
11.6%
10/86 • Number of events 11 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Musculoskeletal and connective tissue disorders
Chest/thoracic pain NOS
|
4.7%
4/86 • Number of events 8 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
7.0%
6/86 • Number of events 12 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Nervous system disorders
Head/headache
|
14.0%
12/86 • Number of events 21 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
8.1%
7/86 • Number of events 9 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
5.8%
5/86 • Number of events 10 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Musculoskeletal and connective tissue disorders
Neck, pain
|
5.8%
5/86 • Number of events 6 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
General disorders
Pain-other
|
10.5%
9/86 • Number of events 14 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.3%
14/86 • Number of events 25 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
29.1%
25/86 • Number of events 52 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
5.8%
5/86 • Number of events 7 • On day 1 of each 21 day treatment cycle for duration of treatment.
Physical exam, laboratory test, and questions are used to assess adverse events on the first day of every 21 day cycle.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place