Trial Outcomes & Findings for A Phase I/II Clinical Trial of Vidaza With Abraxane in Patients With Advanced/Metastatic Solid Tumors and Breast Cancer (NCT NCT00748553)
NCT ID: NCT00748553
Last Updated: 2017-07-26
Results Overview
Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2 based on the number of participants responding to treatment as measured per RECIST v1 criteria.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
6 months
Results posted on
2017-07-26
Participant Flow
Participant milestones
| Measure |
Phase 1
Azacitidine (Vidaza): 50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle
Nab-paclitaxel (Abraxane): 100mg/m2 weekly for 3 weeks of each 4-week cycle
|
Phase II
Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Phase 1
Azacitidine (Vidaza): 50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle
Nab-paclitaxel (Abraxane): 100mg/m2 weekly for 3 weeks of each 4-week cycle
|
Phase II
Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
disease progression
|
2
|
0
|
|
Overall Study
noncompliance
|
1
|
0
|
Baseline Characteristics
A Phase I/II Clinical Trial of Vidaza With Abraxane in Patients With Advanced/Metastatic Solid Tumors and Breast Cancer
Baseline characteristics by cohort
| Measure |
Phase II
n=14 Participants
Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2
|
Phase I
n=16 Participants
Azacitidine (Vidaza): 50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle
Nab-paclitaxel (Abraxane): 100mg/m2 weekly for 3 weeks of each 4-week cycle
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
62 years
n=7 Participants
|
63.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 16 patients were evaluable for toxicity. 13 were evaluable for response per RECIST v1.
Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2 based on the number of participants responding to treatment as measured per RECIST v1 criteria.
Outcome measures
| Measure |
Phase 1
n=13 Participants
Azacitidine (Vidaza): 50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle
Nab-paclitaxel (Abraxane): 100mg/m2 weekly for 3 weeks of each 4-week cycle
|
|---|---|
|
Phase I: Percentage of Participants Responding to Treatment
|
61.5 percent of participants with response
Interval 35.0 to 87.95
|
PRIMARY outcome
Timeframe: 1.5 yearsPopulation: Of the 14 patients enrolled on the Phase II portion of trial, one patient opted out off trial after 1 cycle because of toxicity.
Objective response rate (ORR) will be measured using RECIST 1.0 criteria. The best response, including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD), for each patient will be summarized. For target lesions, Complete Response is defined as disappearance of all target lesions for at least 4 weeks; Partial Response consists of at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD, for at least 4 weeks; Progressive Disease consists of 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; Stable Disease consists of 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.
Outcome measures
| Measure |
Phase 1
n=13 Participants
Azacitidine (Vidaza): 50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle
Nab-paclitaxel (Abraxane): 100mg/m2 weekly for 3 weeks of each 4-week cycle
|
|---|---|
|
Phase II: Percentage of Participants With Objective Response Rate (ORR) Measured Using RECIST 1.0 Criteria
|
53.8 percentage of participants
Interval 26.7 to 80.9
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Of the 14 patients enrolled on the Phase II portion of trial, one patient opted out off trial after 1 cycle because of toxicity. Thirteen patients were evaluated for ER+ status.
Tissue SPARC protein will be assessed using archival tumor blocks. In addition, in patients who have easily accessible tumors, such as lymph nodes, cutaneous or subcutaneous lesions, and who have consented to sample collection, biopsies will be taken twice: before cycle 1 day 1 treatment, and cycle 3 day 8 (+/- 3 days).
Outcome measures
| Measure |
Phase 1
n=13 Participants
Azacitidine (Vidaza): 50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle
Nab-paclitaxel (Abraxane): 100mg/m2 weekly for 3 weeks of each 4-week cycle
|
|---|---|
|
Number of Participants With ER+ Status
|
11 participants were ER+
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data were not collected.
Progression-free survival (PSF) is defined as the length of time during and after treatment in which a patient is living with a disease that does not get worse.
Outcome measures
Outcome data not reported
Adverse Events
Phase I and II
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase I and II
n=30 participants at risk
Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
10/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Blood and lymphatic system disorders
Anemia
|
26.7%
8/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
5/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.3%
1/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
General disorders
chills
|
6.7%
2/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
2/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Psychiatric disorders
Depression
|
3.3%
1/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
6/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Nervous system disorders
Dizziness
|
20.0%
6/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
2/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Nervous system disorders
Dysgeusia
|
6.7%
2/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.3%
1/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
General disorders
Edema
|
13.3%
4/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Vascular disorders
Embolism
|
3.3%
1/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
General disorders
Fatigue
|
60.0%
18/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
General disorders
Fever
|
3.3%
1/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Nervous system disorders
Headache
|
3.3%
1/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.3%
1/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Reproductive system and breast disorders
Hot flashes
|
6.7%
2/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Investigations
Hypoalbuminemia
|
3.3%
1/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
General disorders
Injection Site Reaction
|
3.3%
1/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Psychiatric disorders
Insomnia
|
6.7%
2/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Investigations
White Blood Cell Decreased
|
43.3%
13/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Nervous system disorders
Memory impairment
|
3.3%
1/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Gastrointestinal disorders
Mucositis
|
10.0%
3/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
16.7%
5/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
6.7%
2/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Gastrointestinal disorders
Nausea
|
36.7%
11/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Nervous system disorders
Neuropathy
|
46.7%
14/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Investigations
Neutropenia
|
36.7%
11/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
General disorders
Non-Cardiac chest pain
|
3.3%
1/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
General disorders
Pain
|
13.3%
4/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Infections and infestations
Sinusitis
|
3.3%
1/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Infections and infestations
Rash
|
13.3%
4/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Infections and infestations
Rhinitis
|
3.3%
1/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
General disorders
taste alteration
|
16.7%
5/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Nervous system disorders
Tremor
|
3.3%
1/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Gastrointestinal disorders
Vomiting
|
23.3%
7/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Investigations
Weight loss
|
3.3%
1/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Gastrointestinal disorders
Dyspnea
|
3.3%
1/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Skin and subcutaneous tissue disorders
Puritis
|
6.7%
2/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
3.3%
1/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
General disorders
Weakness
|
16.7%
5/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
6.7%
2/30 • Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.
Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place