Trial Outcomes & Findings for Exploratory Study of Sunitinib Malate as a Component of Neoadjuvant Therapy for Breast Cancer (NCT NCT00656669)
NCT ID: NCT00656669
Last Updated: 2023-05-23
Results Overview
Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 1 (sunitinib monotherapy) and the mean baseline value.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
baseline through end of segment 1 (2 weeks)
Results posted on
2023-05-23
Participant Flow
Please note that one patient discontinued due to an Adverse Event after completing Segment 2 (Paclitaxel/Sunitinib), but before starting Segment 3 adriamycin \& cyclophosphamide (AC).
Participant milestones
| Measure |
Segment Information
This is an exploratory phase 2 and biomarker clinical trial of sunitinib in the neoadjuvant setting for the treatment of breast cancer. The study will be conducted in 3 sequential treatment segments. During the first segment, patients will receive single-agent sunitinib for 2 weeks for the purpose of biomarker and IFP evaluation. Patients will then begin the second segment, 4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel. Sunitinib will be discontinued after Cycle 5 Day 21. The third segment will include 4 cycles (8 weeks) of neoadjuvant treatment with AC followed by surgical resection and determination of pathological response.
|
|---|---|
|
Single Agent Sunitinib (Cycle 1)
STARTED
|
23
|
|
Single Agent Sunitinib (Cycle 1)
COMPLETED
|
23
|
|
Single Agent Sunitinib (Cycle 1)
NOT COMPLETED
|
0
|
|
Paclitaxel/Sunitinib (Cycles 2-5)
STARTED
|
23
|
|
Paclitaxel/Sunitinib (Cycles 2-5)
COMPLETED
|
17
|
|
Paclitaxel/Sunitinib (Cycles 2-5)
NOT COMPLETED
|
6
|
|
AC (Cycles 6-9)
STARTED
|
17
|
|
AC (Cycles 6-9)
COMPLETED
|
15
|
|
AC (Cycles 6-9)
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Segment Information
This is an exploratory phase 2 and biomarker clinical trial of sunitinib in the neoadjuvant setting for the treatment of breast cancer. The study will be conducted in 3 sequential treatment segments. During the first segment, patients will receive single-agent sunitinib for 2 weeks for the purpose of biomarker and IFP evaluation. Patients will then begin the second segment, 4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel. Sunitinib will be discontinued after Cycle 5 Day 21. The third segment will include 4 cycles (8 weeks) of neoadjuvant treatment with AC followed by surgical resection and determination of pathological response.
|
|---|---|
|
Paclitaxel/Sunitinib (Cycles 2-5)
Adverse Event
|
4
|
|
Paclitaxel/Sunitinib (Cycles 2-5)
Physician Decision
|
2
|
|
AC (Cycles 6-9)
Adverse Event
|
1
|
|
AC (Cycles 6-9)
Did not start segment 3
|
1
|
Baseline Characteristics
Exploratory Study of Sunitinib Malate as a Component of Neoadjuvant Therapy for Breast Cancer
Baseline characteristics by cohort
| Measure |
Overall Study
n=23 Participants
These patients are for the patients who were into the trial.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
48.3 Years
STANDARD_DEVIATION 8.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline through end of segment 1 (2 weeks)Population: All patients that had both measures at baseline and endpoint in the sunitinib monotherapy segment
Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 1 (sunitinib monotherapy) and the mean baseline value.
Outcome measures
| Measure |
Sunitinib Monotherapy
n=19 Participants
Patients who completed the Sunitinib monotherapy segment
|
|---|---|
|
Change in Interstitial Fluid Pressure (IFP) Induced by Sunitinib Monotherapy
|
14.0 mm Hg
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: end of cycle 1 (sunitinib monotherapy) to end of cycle 5 (paclitaxel/sunitinib therapy) (112 days)Population: All patients in the paclitaxel plus sunitinib segment
Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 2 (paclitaxel/sunitinib therapy through cycle 5) and end of segment 1 (sunitinib monotherapy) mean value.
Outcome measures
| Measure |
Sunitinib Monotherapy
n=6 Participants
Patients who completed the Sunitinib monotherapy segment
|
|---|---|
|
Change in Interstitial Fluid Pressure (IFP) Induced by Paclitaxel Plus Sunitinib After Sunitinib Monotherapy
|
1.7 mm Hg
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: screening through surgeryPopulation: All patients who had surgery.
Outcome measures
| Measure |
Sunitinib Monotherapy
n=15 Participants
Patients who completed the Sunitinib monotherapy segment
|
|---|---|
|
Pathological Complete Response (pCR) Rate for Patients Treated With Sunitinib/Paclitaxel Followed by AC as Neoadjuvant Therapy for Breast Cancer
|
53.3 percentage of participants
Interval 26.6 to 78.7
|
SECONDARY outcome
Timeframe: end of cycle 1 (sunitinib monotherapy) to end of cycle 5 (paclitaxel/sunitinib therapy)Population: All patients who were on paclitaxel plus sunitinib.
This measure determines the number of patients who had Grade 3/4 Adverse Events that were related to treatment while the patient was on paclitaxel plus sunitinib.
Outcome measures
| Measure |
Sunitinib Monotherapy
n=23 Participants
Patients who completed the Sunitinib monotherapy segment
|
|---|---|
|
To Evaluate the Safety of Paclitaxel Plus Sunitinib When Given in Combination as Neoadjuvant Therapy
|
11 participants
|
Adverse Events
Single Agent Sunitinib
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Paclitaxel/Sunitinib
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
AC Dosing
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Agent Sunitinib
n=23 participants at risk
Single-agent sunitinib for 2 weeks for the purpose of biomarker and IFP evaluation.
|
Paclitaxel/Sunitinib
n=23 participants at risk
4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel.
|
AC Dosing
n=16 participants at risk
4 cycles (8 weeks) of neoadjuvant treatment with AC.
|
|---|---|---|---|
|
Cardiac disorders
LEFT VENTRICULAR SYSTOLIC DYSFUNCTION
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
4.3%
1/23 • Number of events 1 • Cycles 1 through 9 of treatment
|
0.00%
0/16 • Cycles 1 through 9 of treatment
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
4.3%
1/23 • Number of events 1 • Cycles 1 through 9 of treatment
|
0.00%
0/16 • Cycles 1 through 9 of treatment
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
4.3%
1/23 • Number of events 1 • Cycles 1 through 9 of treatment
|
0.00%
0/16 • Cycles 1 through 9 of treatment
|
|
Hepatobiliary disorders
BILIRUBIN (HYPERBILIRUBINEMIA)
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
4.3%
1/23 • Number of events 1 • Cycles 1 through 9 of treatment
|
0.00%
0/16 • Cycles 1 through 9 of treatment
|
|
Infections and infestations
INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
4.3%
1/23 • Number of events 1 • Cycles 1 through 9 of treatment
|
0.00%
0/16 • Cycles 1 through 9 of treatment
|
|
Investigations
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 1 • Cycles 1 through 9 of treatment
|
|
Investigations
FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
12.5%
2/16 • Number of events 2 • Cycles 1 through 9 of treatment
|
Other adverse events
| Measure |
Single Agent Sunitinib
n=23 participants at risk
Single-agent sunitinib for 2 weeks for the purpose of biomarker and IFP evaluation.
|
Paclitaxel/Sunitinib
n=23 participants at risk
4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel.
|
AC Dosing
n=16 participants at risk
4 cycles (8 weeks) of neoadjuvant treatment with AC.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
DERMAL CHANGE LYMPHEDEMA, PHLEBOLYMPHEDEMA
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
4.3%
1/23 • Number of events 1 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 2 • Cycles 1 through 9 of treatment
|
|
Cardiac disorders
LEFT VENTRICULAR SYSTOLIC DYSFUNCTION
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 1 • Cycles 1 through 9 of treatment
|
|
Cardiac disorders
VENTRICULAR ARRHYTHMIA - VENTRICULAR TACHYCARDIA
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 1 • Cycles 1 through 9 of treatment
|
|
Eye disorders
DRY EYE SYNDROME
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 1 • Cycles 1 through 9 of treatment
|
|
Eye disorders
OCULAR/VISUAL - OTHER (SPECIFY, __)
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
8.7%
2/23 • Number of events 2 • Cycles 1 through 9 of treatment
|
0.00%
0/16 • Cycles 1 through 9 of treatment
|
|
Eye disorders
VISION-BLURRED VISION
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 1 • Cycles 1 through 9 of treatment
|
|
Gastrointestinal disorders
CONSTIPATION
|
8.7%
2/23 • Number of events 2 • Cycles 1 through 9 of treatment
|
8.7%
2/23 • Number of events 2 • Cycles 1 through 9 of treatment
|
25.0%
4/16 • Number of events 5 • Cycles 1 through 9 of treatment
|
|
Gastrointestinal disorders
DIARRHEA
|
26.1%
6/23 • Number of events 6 • Cycles 1 through 9 of treatment
|
56.5%
13/23 • Number of events 17 • Cycles 1 through 9 of treatment
|
12.5%
2/16 • Number of events 2 • Cycles 1 through 9 of treatment
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
21.7%
5/23 • Number of events 5 • Cycles 1 through 9 of treatment
|
52.2%
12/23 • Number of events 21 • Cycles 1 through 9 of treatment
|
18.8%
3/16 • Number of events 3 • Cycles 1 through 9 of treatment
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
8.7%
2/23 • Number of events 2 • Cycles 1 through 9 of treatment
|
0.00%
0/16 • Cycles 1 through 9 of treatment
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ORAL CAVITY
|
26.1%
6/23 • Number of events 6 • Cycles 1 through 9 of treatment
|
34.8%
8/23 • Number of events 11 • Cycles 1 through 9 of treatment
|
18.8%
3/16 • Number of events 3 • Cycles 1 through 9 of treatment
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) - ORAL CAVITY
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
8.7%
2/23 • Number of events 2 • Cycles 1 through 9 of treatment
|
12.5%
2/16 • Number of events 2 • Cycles 1 through 9 of treatment
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) - STOMACH
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 1 • Cycles 1 through 9 of treatment
|
|
Gastrointestinal disorders
NAUSEA
|
34.8%
8/23 • Number of events 8 • Cycles 1 through 9 of treatment
|
43.5%
10/23 • Number of events 16 • Cycles 1 through 9 of treatment
|
37.5%
6/16 • Number of events 10 • Cycles 1 through 9 of treatment
|
|
Gastrointestinal disorders
TASTE ALTERATION (DYSGEUSIA)
|
47.8%
11/23 • Number of events 12 • Cycles 1 through 9 of treatment
|
56.5%
13/23 • Number of events 19 • Cycles 1 through 9 of treatment
|
25.0%
4/16 • Number of events 4 • Cycles 1 through 9 of treatment
|
|
Gastrointestinal disorders
VOMITING
|
21.7%
5/23 • Number of events 5 • Cycles 1 through 9 of treatment
|
13.0%
3/23 • Number of events 4 • Cycles 1 through 9 of treatment
|
31.2%
5/16 • Number of events 7 • Cycles 1 through 9 of treatment
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
30.4%
7/23 • Number of events 7 • Cycles 1 through 9 of treatment
|
65.2%
15/23 • Number of events 22 • Cycles 1 through 9 of treatment
|
43.8%
7/16 • Number of events 11 • Cycles 1 through 9 of treatment
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
8.7%
2/23 • Number of events 3 • Cycles 1 through 9 of treatment
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
18.8%
3/16 • Number of events 3 • Cycles 1 through 9 of treatment
|
|
General disorders
PAIN - ABDOMEN NOS
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
13.0%
3/23 • Number of events 3 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 1 • Cycles 1 through 9 of treatment
|
|
General disorders
PAIN - BACK
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
8.7%
2/23 • Number of events 3 • Cycles 1 through 9 of treatment
|
18.8%
3/16 • Number of events 3 • Cycles 1 through 9 of treatment
|
|
General disorders
PAIN - BREAST
|
8.7%
2/23 • Number of events 2 • Cycles 1 through 9 of treatment
|
8.7%
2/23 • Number of events 3 • Cycles 1 through 9 of treatment
|
0.00%
0/16 • Cycles 1 through 9 of treatment
|
|
General disorders
PAIN - CARDIAC/HEART
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 1 • Cycles 1 through 9 of treatment
|
|
General disorders
PAIN - CHEST/THORAX NOS
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
4.3%
1/23 • Number of events 1 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 1 • Cycles 1 through 9 of treatment
|
|
General disorders
PAIN - EXTREMITY-LIMB
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
13.0%
3/23 • Number of events 5 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 1 • Cycles 1 through 9 of treatment
|
|
General disorders
PAIN - HEAD/HEADACHE
|
13.0%
3/23 • Number of events 3 • Cycles 1 through 9 of treatment
|
8.7%
2/23 • Number of events 2 • Cycles 1 through 9 of treatment
|
12.5%
2/16 • Number of events 2 • Cycles 1 through 9 of treatment
|
|
General disorders
PAIN - JOINT
|
4.3%
1/23 • Number of events 1 • Cycles 1 through 9 of treatment
|
17.4%
4/23 • Number of events 4 • Cycles 1 through 9 of treatment
|
18.8%
3/16 • Number of events 4 • Cycles 1 through 9 of treatment
|
|
General disorders
PAIN - MUSCLE
|
4.3%
1/23 • Number of events 1 • Cycles 1 through 9 of treatment
|
21.7%
5/23 • Number of events 6 • Cycles 1 through 9 of treatment
|
12.5%
2/16 • Number of events 2 • Cycles 1 through 9 of treatment
|
|
General disorders
PAIN - OTHER (SPECIFY, __)
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
8.7%
2/23 • Number of events 4 • Cycles 1 through 9 of treatment
|
0.00%
0/16 • Cycles 1 through 9 of treatment
|
|
General disorders
PAIN - STOMACH
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 1 • Cycles 1 through 9 of treatment
|
|
General disorders
PAIN - THROAT/PHARYNX/LARYNX
|
4.3%
1/23 • Number of events 1 • Cycles 1 through 9 of treatment
|
4.3%
1/23 • Number of events 3 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 1 • Cycles 1 through 9 of treatment
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - PARANASAL
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 1 • Cycles 1 through 9 of treatment
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SINUS
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
4.3%
1/23 • Number of events 1 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 1 • Cycles 1 through 9 of treatment
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SKIN (CELLULITIS)
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
4.3%
1/23 • Number of events 1 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 1 • Cycles 1 through 9 of treatment
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - UPPER AIRWAY NOS
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 1 • Cycles 1 through 9 of treatment
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC - URINARY TRACT NOS
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 1 • Cycles 1 through 9 of treatment
|
|
Injury, poisoning and procedural complications
BURN
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 1 • Cycles 1 through 9 of treatment
|
|
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
4.3%
1/23 • Number of events 1 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 1 • Cycles 1 through 9 of treatment
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
4.3%
1/23 • Number of events 1 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 1 • Cycles 1 through 9 of treatment
|
|
Investigations
HEMOGLOBIN
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 3 • Cycles 1 through 9 of treatment
|
|
Investigations
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
43.5%
10/23 • Number of events 14 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 1 • Cycles 1 through 9 of treatment
|
|
Investigations
PLATELETS
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
17.4%
4/23 • Number of events 4 • Cycles 1 through 9 of treatment
|
0.00%
0/16 • Cycles 1 through 9 of treatment
|
|
Metabolism and nutrition disorders
ANOREXIA
|
21.7%
5/23 • Number of events 6 • Cycles 1 through 9 of treatment
|
52.2%
12/23 • Number of events 18 • Cycles 1 through 9 of treatment
|
50.0%
8/16 • Number of events 9 • Cycles 1 through 9 of treatment
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
17.4%
4/23 • Number of events 4 • Cycles 1 through 9 of treatment
|
47.8%
11/23 • Number of events 17 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 1 • Cycles 1 through 9 of treatment
|
|
Psychiatric disorders
INSOMNIA
|
8.7%
2/23 • Number of events 2 • Cycles 1 through 9 of treatment
|
34.8%
8/23 • Number of events 9 • Cycles 1 through 9 of treatment
|
12.5%
2/16 • Number of events 2 • Cycles 1 through 9 of treatment
|
|
Psychiatric disorders
MOOD ALTERATION - ANXIETY
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
13.0%
3/23 • Number of events 3 • Cycles 1 through 9 of treatment
|
0.00%
0/16 • Cycles 1 through 9 of treatment
|
|
Psychiatric disorders
MOOD ALTERATION - DEPRESSION
|
4.3%
1/23 • Number of events 1 • Cycles 1 through 9 of treatment
|
17.4%
4/23 • Number of events 4 • Cycles 1 through 9 of treatment
|
12.5%
2/16 • Number of events 2 • Cycles 1 through 9 of treatment
|
|
Reproductive system and breast disorders
HOT FLASHES/FLUSHES
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
21.7%
5/23 • Number of events 5 • Cycles 1 through 9 of treatment
|
18.8%
3/16 • Number of events 3 • Cycles 1 through 9 of treatment
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
43.5%
10/23 • Number of events 14 • Cycles 1 through 9 of treatment
|
18.8%
3/16 • Number of events 3 • Cycles 1 through 9 of treatment
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
8.7%
2/23 • Number of events 2 • Cycles 1 through 9 of treatment
|
39.1%
9/23 • Number of events 10 • Cycles 1 through 9 of treatment
|
12.5%
2/16 • Number of events 2 • Cycles 1 through 9 of treatment
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
17.4%
4/23 • Number of events 5 • Cycles 1 through 9 of treatment
|
0.00%
0/16 • Cycles 1 through 9 of treatment
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __)
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
4.3%
1/23 • Number of events 1 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 1 • Cycles 1 through 9 of treatment
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
8.7%
2/23 • Number of events 2 • Cycles 1 through 9 of treatment
|
0.00%
0/16 • Cycles 1 through 9 of treatment
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS/ALOPECIA (SCALP OR BODY)
|
4.3%
1/23 • Number of events 1 • Cycles 1 through 9 of treatment
|
78.3%
18/23 • Number of events 23 • Cycles 1 through 9 of treatment
|
12.5%
2/16 • Number of events 2 • Cycles 1 through 9 of treatment
|
|
Skin and subcutaneous tissue disorders
HYPERPIGMENTATION
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
4.3%
1/23 • Number of events 1 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 1 • Cycles 1 through 9 of treatment
|
|
Skin and subcutaneous tissue disorders
HYPOPIGMENTATION
|
8.7%
2/23 • Number of events 2 • Cycles 1 through 9 of treatment
|
8.7%
2/23 • Number of events 2 • Cycles 1 through 9 of treatment
|
0.00%
0/16 • Cycles 1 through 9 of treatment
|
|
Skin and subcutaneous tissue disorders
NAIL CHANGES
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
17.4%
4/23 • Number of events 4 • Cycles 1 through 9 of treatment
|
0.00%
0/16 • Cycles 1 through 9 of treatment
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
30.4%
7/23 • Number of events 9 • Cycles 1 through 9 of treatment
|
6.2%
1/16 • Number of events 1 • Cycles 1 through 9 of treatment
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
0.00%
0/23 • Cycles 1 through 9 of treatment
|
13.0%
3/23 • Number of events 5 • Cycles 1 through 9 of treatment
|
0.00%
0/16 • Cycles 1 through 9 of treatment
|
|
Skin and subcutaneous tissue disorders
RASH: ACNE/ACNEIFORM
|
13.0%
3/23 • Number of events 4 • Cycles 1 through 9 of treatment
|
21.7%
5/23 • Number of events 7 • Cycles 1 through 9 of treatment
|
18.8%
3/16 • Number of events 3 • Cycles 1 through 9 of treatment
|
|
Skin and subcutaneous tissue disorders
RASH: HAND-FOOT SKIN REACTION
|
4.3%
1/23 • Number of events 1 • Cycles 1 through 9 of treatment
|
30.4%
7/23 • Number of events 10 • Cycles 1 through 9 of treatment
|
12.5%
2/16 • Number of events 2 • Cycles 1 through 9 of treatment
|
|
Vascular disorders
HYPERTENSION
|
17.4%
4/23 • Number of events 4 • Cycles 1 through 9 of treatment
|
30.4%
7/23 • Number of events 8 • Cycles 1 through 9 of treatment
|
0.00%
0/16 • Cycles 1 through 9 of treatment
|
Additional Information
Dr. Kathy Miller
IndianaU
Phone: 317-944-0920
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place