Trial Outcomes & Findings for Tariquidar and Docetaxel to Treat Patients With Lung, Ovarian, Renal and Cervical Cancer (NCT NCT00069160)
NCT ID: NCT00069160
Last Updated: 2012-10-12
Results Overview
In the first cycle patients were to receive docetaxel on days 1 and 8 and to be randomized to receive tariquidar on either day 1 or 8. Thus pharmacokinetic data with and without tariquidar can be compared.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
24 hours
Results posted on
2012-10-12
Participant Flow
Participant milestones
| Measure |
Pts Who Received Docetaxel on Day 1, 8, & Tariquidar Day 8,22
Patients receive 40 mg/m\^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m\^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
|
Pts Who Received Docetaxel on Days 1, 8, & Tariquidar Day 1,22
Patients receive docetaxel intravenous (IV) over 1 hour on days 1 and 8 and tariquidar intravenous (IV) over 30 minutes on days 1 and 22.From cycle 2 and onward 75 mg/m\^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
25
|
|
Overall Study
COMPLETED
|
23
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tariquidar and Docetaxel to Treat Patients With Lung, Ovarian, Renal and Cervical Cancer
Baseline characteristics by cohort
| Measure |
Pts Who Received Docetaxel on Day 1, 8, & Tariquidar Day 8,22
n=23 Participants
Patients receive 40 mg/m\^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m\^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
|
Pts Who Received Docetaxel on Days 1, 8, & Tariquidar Day 1,22
n=25 Participants
Patients receive docetaxel intravenous (IV) over 1 hour on days 1 and 8 and tariquidar intravenous (IV) over 30 minutes on days 1 and 22.From cycle 2 and onward 75 mg/m\^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age Continuous
|
50.76 years
STANDARD_DEVIATION 9.54 • n=5 Participants
|
55.77 years
STANDARD_DEVIATION 9.57 • n=7 Participants
|
53.37 years
STANDARD_DEVIATION 9.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
25 participants
n=7 Participants
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Docetaxel alone (C1D1 = 21 patients; C1D8 = 18 patients) Docetaxel with Tariquidar (C1D1 = 21 patients; C1D8 = 16 patients) Data were evaluable in 39 patients. Paired data from 31 participants were evaluable.
In the first cycle patients were to receive docetaxel on days 1 and 8 and to be randomized to receive tariquidar on either day 1 or 8. Thus pharmacokinetic data with and without tariquidar can be compared.
Outcome measures
| Measure |
Docetaxel Alone
n=39 Participants
40 mg/m\^2 docetaxel over 1 hour on days 1 and 8.
|
With Tariquidar
n=37 Participants
40 mg/m\^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on either day 1 or 8 and then again on day 22. From cycle 2 and onward 75 mg/m\^2 docetaxel was administered every 21 days in combination with a single 150 mg dose of tariquidar.
|
|---|---|---|
|
Geometric Mean of Maximum Concentration of the Drug (Cmax)
C1D1
|
1315 Cmax (ng/mL)
Interval 1081.0 to 1598.0
|
1093 Cmax (ng/mL)
Interval 791.2 to 1510.0
|
|
Geometric Mean of Maximum Concentration of the Drug (Cmax)
C1D8
|
1060 Cmax (ng/mL)
Interval 773.5 to 1452.0
|
1026 Cmax (ng/mL)
Interval 807.3 to 1303.0
|
|
Geometric Mean of Maximum Concentration of the Drug (Cmax)
Both Groups (C1D1 + C1D8)
|
1190 Cmax (ng/mL)
Interval 999.9 to 1416.0
|
1063 Cmax (ng/mL)
Interval 869.2 to 1301.0
|
PRIMARY outcome
Timeframe: 4 yrs 8-11 monthsHere are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Docetaxel Alone
n=23 Participants
40 mg/m\^2 docetaxel over 1 hour on days 1 and 8.
|
With Tariquidar
n=25 Participants
40 mg/m\^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on either day 1 or 8 and then again on day 22. From cycle 2 and onward 75 mg/m\^2 docetaxel was administered every 21 days in combination with a single 150 mg dose of tariquidar.
|
|---|---|---|
|
The Number of Participants With Adverse Events.
|
23 participants
|
25 participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Docetaxel alone (C1D1 = 21 patients; C1D8 = 18 patients) Docetaxel with Tariquidar (C1D1 = 21 patients; C1D8 = 16 patients) Pharmacokinetic data were evaluable in 39 patients. Paired data from 31 participants were evaluable.
Outcome measures
| Measure |
Docetaxel Alone
n=39 Participants
40 mg/m\^2 docetaxel over 1 hour on days 1 and 8.
|
With Tariquidar
n=37 Participants
40 mg/m\^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on either day 1 or 8 and then again on day 22. From cycle 2 and onward 75 mg/m\^2 docetaxel was administered every 21 days in combination with a single 150 mg dose of tariquidar.
|
|---|---|---|
|
Geometric Mean of Area Under Curve (AUC0)-24
C1D8
|
1308 h*ng/mL
Interval 989.8 to 1730.0
|
1327 h*ng/mL
Interval 1084.0 to 1623.0
|
|
Geometric Mean of Area Under Curve (AUC0)-24
C1D1
|
1367 h*ng/mL
Interval 1126.0 to 1658.0
|
1409 h*ng/mL
Interval 1172.0 to 1694.0
|
|
Geometric Mean of Area Under Curve (AUC0)-24
Both Groups (C1D1 + C1D8)
|
1339 h*ng/mL
Interval 1144.0 to 1568.0
|
1373 h*ng/mL
Interval 1206.0 to 1563.0
|
PRIMARY outcome
Timeframe: 4 years, 8-11 monthsResponse is determined by RECIST criteria defined as changes in only the largest diameter (unidimensional measurement) of the tumor lesion. Lesions are either measurable or non-measurable. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>/- 20 mm with conventional techniques (CT, MRI, xray) or as \>/- 10 mm with a spiral CT scan. Non-measurable lesions are defined as all other lesions (or sites of disease) including small lesions (longest diameter \<20 mm with conventional techniques or \<10 mm using spiral CT.
Outcome measures
| Measure |
Docetaxel Alone
n=48 Participants
40 mg/m\^2 docetaxel over 1 hour on days 1 and 8.
|
With Tariquidar
40 mg/m\^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on either day 1 or 8 and then again on day 22. From cycle 2 and onward 75 mg/m\^2 docetaxel was administered every 21 days in combination with a single 150 mg dose of tariquidar.
|
|---|---|---|
|
Clinical Response Rate
|
8 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 3 - 24 hoursPopulation: Percent increase in sestamibi AUC in liver after tariquidar.
A significant change in the area under the curve(AUC) in liver tissue (normal tissue as a surrogate) is defined as P\<0.001. A secondary objective of this study was to establish whether tariquidar (150 mg) modulates Pgp in liver. Sestamibi is a Pgp substrate that may be a surrogate for measuring drug efflux from tumors. A baseline Tc-sestamibi scan was obtained before the administration of tariquidar. A minimum of 48 hours later, on or about day 22 a single dose of tariquidar was administered, followed by a second Tc-sestamibi scan.
Outcome measures
| Measure |
Docetaxel Alone
n=35 Participants
40 mg/m\^2 docetaxel over 1 hour on days 1 and 8.
|
With Tariquidar
40 mg/m\^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on either day 1 or 8 and then again on day 22. From cycle 2 and onward 75 mg/m\^2 docetaxel was administered every 21 days in combination with a single 150 mg dose of tariquidar.
|
|---|---|---|
|
Percent Increase in Sestamibi Area Under Curve (AUC) in Liver After Tariquidar
|
82.2 percent increase in sestamibi AUC
Interval 5.8 to 252.0
|
—
|
SECONDARY outcome
Timeframe: 3-24 hours99mTc-sestamibi is a radionuclide imaging agent used to study cardiac function that has also been shown to be a substrate for P-glycoprotein- mediated drug efflux. Because of the high expression of Pgp in liver tissue, sestamibi uptake in liver tissue is often monitored as a marker of Pgp inhibition. A significant change in the area under the curve(AUC) in liver tissue (normal tissue as a surrogate) is defined as P\<0.001.
Outcome measures
| Measure |
Docetaxel Alone
n=31 Participants
40 mg/m\^2 docetaxel over 1 hour on days 1 and 8.
|
With Tariquidar
40 mg/m\^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on either day 1 or 8 and then again on day 22. From cycle 2 and onward 75 mg/m\^2 docetaxel was administered every 21 days in combination with a single 150 mg dose of tariquidar.
|
|---|---|---|
|
Percent Increase in Sestamibi Area Under Curve (AUC) in Tumor Tissue
|
12.4 Percent
Interval 7.2 to 24.1
|
—
|
Adverse Events
Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22
Serious events: 6 serious events
Other events: 23 other events
Deaths: 0 deaths
Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22
Serious events: 8 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22
n=23 participants at risk
Patients receive 40 mg/m\^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m\^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
|
Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22
n=25 participants at risk
Patients receive 40 mg/m\^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m\^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
|
|---|---|---|
|
Investigations
BLOOD/BONE MARROW:: Leukocytes (total WBC)
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
General disorders
CONSTITUTIONAL SYMPTOMS:: Fatigue (lethargy, malaise, asthenia)
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
General disorders
CONSTITUTIONAL SYMPTOMS::
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
8.0%
2/25 • Number of events 2 • 4 years and 11 months
|
|
General disorders
CONSTITUTIONAL SYMPTOMS:: Rigors, chills
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Alopecia
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL:: Musculoskeletal-Other (Specify,musculoskeletal-lethargic)
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Nervous system disorders
NEUROLOGY:: Dizziness/lightheadedness
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY:: Dyspnea (shortness of breath)
|
8.7%
2/23 • Number of events 2 • 4 years and 11 months
|
12.0%
3/25 • Number of events 3 • 4 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY:: Pulmonary-Other (Specify,clinical deterioration)
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Investigations
BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC)
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Cardiac disorders
CARDIOVASCULAR (GENERAL):: Hypotension
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Cardiac disorders
CARDIOVASCULAR (GENERAL):: Thrombosis/embolism
|
0.00%
0/23 • 4 years and 11 months
|
8.0%
2/25 • Number of events 2 • 4 years and 11 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Anorexia
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Gastrointestinal disorders
HEMORRHAGE:: Rectal bleeding/hematochezia
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Investigations
HEPATIC:: Alkaline phosphatase
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Investigations
HEPATIC:: SGOT (AST) (serum glutamic oxaloacetic transaminase)
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Investigations
HEPATIC:: SGPT (ALT) (serum glutamic pyruvic transaminase)
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Infections and infestations
INFECTION/FEBRILE NEUTROPENIA:: Febrile neutropenia (fever of unknown origin without clinically or m
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hyponatremia
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL:: Muscle weakness (not due to neuropathy)
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Nervous system disorders
NEUROLOGY:: Depressed level of consciousness
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Nervous system disorders
NEUROLOGY:: Mood alteration-anxiety, agitation
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY:: Cough
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
Other adverse events
| Measure |
Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22
n=23 participants at risk
Patients receive 40 mg/m\^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m\^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
|
Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22
n=25 participants at risk
Patients receive 40 mg/m\^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m\^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
|
|---|---|---|
|
Ear and labyrinth disorders
AUDITORY/HEARING:: Middle ear/hearing
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW:: Hemoglobin
|
78.3%
18/23 • Number of events 130 • 4 years and 11 months
|
84.0%
21/25 • Number of events 72 • 4 years and 11 months
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW:: Leukocytes (total WBC)
|
78.3%
18/23 • Number of events 86 • 4 years and 11 months
|
84.0%
21/25 • Number of events 77 • 4 years and 11 months
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW:: Lymphopenia
|
8.7%
2/23 • Number of events 9 • 4 years and 11 months
|
16.0%
4/25 • Number of events 21 • 4 years and 11 months
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC)
|
82.6%
19/23 • Number of events 62 • 4 years and 11 months
|
64.0%
16/25 • Number of events 41 • 4 years and 11 months
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW:: Platelets
|
30.4%
7/23 • Number of events 22 • 4 years and 11 months
|
24.0%
6/25 • Number of events 31 • 4 years and 11 months
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW:: Transfusion: pRBCs
|
13.0%
3/23 • Number of events 5 • 4 years and 11 months
|
36.0%
9/25 • Number of events 11 • 4 years and 11 months
|
|
Cardiac disorders
CARDIOVASCULAR (ARRHYTHMIA):: Sinus tachycardia
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Cardiac disorders
CARDIOVASCULAR (GENERAL):: Edema
|
30.4%
7/23 • Number of events 18 • 4 years and 11 months
|
32.0%
8/25 • Number of events 8 • 4 years and 11 months
|
|
Cardiac disorders
CARDIOVASCULAR (GENERAL):: Hypertension
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Cardiac disorders
CARDIOVASCULAR (GENERAL):: Hypotension
|
8.7%
2/23 • Number of events 2 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Cardiac disorders
CARDIOVASCULAR (GENERAL):: Phlebitis (superficial)
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Cardiac disorders
CARDIOVASCULAR (GENERAL):: Thrombosis/embolism
|
8.7%
2/23 • Number of events 3 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Blood and lymphatic system disorders
COAGULATION:: Partial thromboplastin time (PTT)
|
39.1%
9/23 • Number of events 17 • 4 years and 11 months
|
24.0%
6/25 • Number of events 10 • 4 years and 11 months
|
|
Blood and lymphatic system disorders
COAGULATION:: Prothrombin time (PT)
|
13.0%
3/23 • Number of events 6 • 4 years and 11 months
|
16.0%
4/25 • Number of events 13 • 4 years and 11 months
|
|
General disorders
CONSTITUTIONAL SYMPTOMS:: Fatigue (lethargy, malaise, asthenia)
|
78.3%
18/23 • Number of events 42 • 4 years and 11 months
|
84.0%
21/25 • Number of events 56 • 4 years and 11 months
|
|
General disorders
CONSTITUTIONAL SYMPTOMS:: Fever (in the absence of neutropenia, where neutropenia is defined as AGC<
|
26.1%
6/23 • Number of events 13 • 4 years and 11 months
|
16.0%
4/25 • Number of events 5 • 4 years and 11 months
|
|
General disorders
CONSTITUTIONAL SYMPTOMS:: Rigors, chills
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
General disorders
CONSTITUTIONAL SYMPTOMS:: Weight loss
|
13.0%
3/23 • Number of events 3 • 4 years and 11 months
|
12.0%
3/25 • Number of events 3 • 4 years and 11 months
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Alopecia
|
34.8%
8/23 • Number of events 9 • 4 years and 11 months
|
32.0%
8/25 • Number of events 10 • 4 years and 11 months
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Dermatology/Skin-Other (Specify,_____)
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Dry skin
|
13.0%
3/23 • Number of events 3 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Flushing
|
17.4%
4/23 • Number of events 7 • 4 years and 11 months
|
4.0%
1/25 • Number of events 2 • 4 years and 11 months
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Hand-foot skin reaction
|
17.4%
4/23 • Number of events 5 • 4 years and 11 months
|
12.0%
3/25 • Number of events 3 • 4 years and 11 months
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Injection site reaction
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
20.0%
5/25 • Number of events 5 • 4 years and 11 months
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Nail changes
|
26.1%
6/23 • Number of events 9 • 4 years and 11 months
|
32.0%
8/25 • Number of events 8 • 4 years and 11 months
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Radiation dermatitis
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Rash/desquamation
|
17.4%
4/23 • Number of events 4 • 4 years and 11 months
|
12.0%
3/25 • Number of events 4 • 4 years and 11 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Anorexia
|
52.2%
12/23 • Number of events 21 • 4 years and 11 months
|
52.0%
13/25 • Number of events 21 • 4 years and 11 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Constipation
|
43.5%
10/23 • Number of events 13 • 4 years and 11 months
|
16.0%
4/25 • Number of events 5 • 4 years and 11 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Dehydration
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Diarrhea patients without colostomy
|
73.9%
17/23 • Number of events 33 • 4 years and 11 months
|
68.0%
17/25 • Number of events 37 • 4 years and 11 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Dyspepsia/heartburn
|
13.0%
3/23 • Number of events 5 • 4 years and 11 months
|
8.0%
2/25 • Number of events 2 • 4 years and 11 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Dysphagia, esophagitis, odynophagia (painful swallowing)
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Flatulence
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
12.0%
3/25 • Number of events 3 • 4 years and 11 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Gastrointestinal-Other (Specify,_____)
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Mouth dryness
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Nausea
|
0.00%
0/23 • 4 years and 11 months
|
48.0%
12/25 • Number of events 19 • 4 years and 11 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Stomatitis/pharyngitis (oral/pharyngeal mucositis)
|
30.4%
7/23 • Number of events 18 • 4 years and 11 months
|
32.0%
8/25 • Number of events 13 • 4 years and 11 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Taste disturbance (dysgeusia)
|
26.1%
6/23 • Number of events 11 • 4 years and 11 months
|
40.0%
10/25 • Number of events 17 • 4 years and 11 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Vomiting
|
43.5%
10/23 • Number of events 17 • 4 years and 11 months
|
28.0%
7/25 • Number of events 8 • 4 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE:: Epistaxis
|
8.7%
2/23 • Number of events 2 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Investigations
HEPATIC:: Alkaline phosphatase
|
30.4%
7/23 • Number of events 13 • 4 years and 11 months
|
8.0%
2/25 • Number of events 2 • 4 years and 11 months
|
|
Investigations
HEPATIC:: Bilirubin
|
21.7%
5/23 • Number of events 14 • 4 years and 11 months
|
12.0%
3/25 • Number of events 7 • 4 years and 11 months
|
|
Metabolism and nutrition disorders
HEPATIC:: Hypoalbuminemia
|
69.6%
16/23 • Number of events 36 • 4 years and 11 months
|
48.0%
12/25 • Number of events 40 • 4 years and 11 months
|
|
Investigations
HEPATIC:: SGOT (AST) (serum glutamic oxaloacetic transaminase)
|
30.4%
7/23 • Number of events 11 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Investigations
HEPATIC:: SGPT (ALT) (serum glutamic pyruvic transaminase)
|
21.7%
5/23 • Number of events 6 • 4 years and 11 months
|
8.0%
2/25 • Number of events 2 • 4 years and 11 months
|
|
Infections and infestations
INFECTION/FEBRILE NEUTROPENIA:: Catheter-related infection
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Infections and infestations
INFECTION/FEBRILE NEUTROPENIA::
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Infections and infestations
INFECTION/FEBRILE NEUTROPENIA:: Infection without neutropenia
|
17.4%
4/23 • Number of events 7 • 4 years and 11 months
|
20.0%
5/25 • Number of events 6 • 4 years and 11 months
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Bicarbonate
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Investigations
METABOLIC/LABORATORY:: CPK (creatine phosphokinase)
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hypercalcemia
|
4.3%
1/23 • Number of events 2 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hyperglycemia
|
43.5%
10/23 • Number of events 26 • 4 years and 11 months
|
44.0%
11/25 • Number of events 23 • 4 years and 11 months
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hyperkalemia
|
8.7%
2/23 • Number of events 2 • 4 years and 11 months
|
12.0%
3/25 • Number of events 5 • 4 years and 11 months
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hypermagnesemia
|
13.0%
3/23 • Number of events 5 • 4 years and 11 months
|
12.0%
3/25 • Number of events 4 • 4 years and 11 months
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hypernatremia
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hypocalcemia
|
30.4%
7/23 • Number of events 20 • 4 years and 11 months
|
28.0%
7/25 • Number of events 21 • 4 years and 11 months
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hypoglycemia
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hypomagnesemia
|
34.8%
8/23 • Number of events 18 • 4 years and 11 months
|
16.0%
4/25 • Number of events 6 • 4 years and 11 months
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hyponatremia
|
60.9%
14/23 • Number of events 36 • 4 years and 11 months
|
60.0%
15/25 • Number of events 26 • 4 years and 11 months
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hypophosphatemia
|
13.0%
3/23 • Number of events 9 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL:: Muscle weakness (not due to neuropathy)
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
20.0%
5/25 • Number of events 7 • 4 years and 11 months
|
|
Nervous system disorders
NEUROLOGY:: Ataxia (incoordination)
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Nervous system disorders
NEUROLOGY:: Confusion
|
4.3%
1/23 • Number of events 2 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Nervous system disorders
NEUROLOGY:: Depressed level of consciousness
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Nervous system disorders
NEUROLOGY:: Dizziness/lightheadedness
|
21.7%
5/23 • Number of events 5 • 4 years and 11 months
|
12.0%
3/25 • Number of events 3 • 4 years and 11 months
|
|
Nervous system disorders
NEUROLOGY:: Extrapyramidal/involuntary movement/restlessness
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Nervous system disorders
NEUROLOGY:: Insomnia
|
17.4%
4/23 • Number of events 4 • 4 years and 11 months
|
12.0%
3/25 • Number of events 3 • 4 years and 11 months
|
|
Nervous system disorders
NEUROLOGY:: Mood alteration-depression
|
8.7%
2/23 • Number of events 2 • 4 years and 11 months
|
8.0%
2/25 • Number of events 2 • 4 years and 11 months
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY:: Hypokalemia
|
21.7%
5/23 • Number of events 6 • 4 years and 11 months
|
12.0%
3/25 • Number of events 6 • 4 years and 11 months
|
|
Nervous system disorders
NEUROLOGY:: Neuropathy-sensory
|
26.1%
6/23 • Number of events 7 • 4 years and 11 months
|
32.0%
8/25 • Number of events 11 • 4 years and 11 months
|
|
Nervous system disorders
NEUROLOGY:: Seizure(s)
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Nervous system disorders
NEUROLOGY:: Syncope (fainting
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Nervous system disorders
NEUROLOGY:: Vertigo
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Eye disorders
OCULAR/VISUAL:: Conjunctivitis
|
8.7%
2/23 • Number of events 2 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Eye disorders
OCULAR/VISUAL:: Dry eye
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Eye disorders
OCULAR/VISUAL:: Tearing (watery eyes)
|
39.1%
9/23 • Number of events 11 • 4 years and 11 months
|
24.0%
6/25 • Number of events 10 • 4 years and 11 months
|
|
Reproductive system and breast disorders
PAIN:: Abdominal pain or cramping
|
21.7%
5/23 • Number of events 5 • 4 years and 11 months
|
24.0%
6/25 • Number of events 8 • 4 years and 11 months
|
|
Musculoskeletal and connective tissue disorders
PAIN:: Arthralgia (joint pain)
|
26.1%
6/23 • Number of events 9 • 4 years and 11 months
|
24.0%
6/25 • Number of events 10 • 4 years and 11 months
|
|
Musculoskeletal and connective tissue disorders
PAIN:: Bone pain
|
13.0%
3/23 • Number of events 5 • 4 years and 11 months
|
16.0%
4/25 • Number of events 5 • 4 years and 11 months
|
|
General disorders
PAIN:: Chest pain (non-cardiac and non-pleuritic)
|
17.4%
4/23 • Number of events 4 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Musculoskeletal and connective tissue disorders
PAIN:: Myalgia (muscle pain)
|
30.4%
7/23 • Number of events 22 • 4 years and 11 months
|
32.0%
8/25 • Number of events 12 • 4 years and 11 months
|
|
Nervous system disorders
PAIN:: Neuropathic pain (e.g., jaw pain, neurologic pain, phantom limb pain, post-infectious neuralg
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Nervous system disorders
PAIN:: Pain-Other (Specify,___)
|
39.1%
9/23 • Number of events 11 • 4 years and 11 months
|
8.0%
2/25 • Number of events 2 • 4 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY:: Cough
|
39.1%
9/23 • Number of events 9 • 4 years and 11 months
|
12.0%
3/25 • Number of events 3 • 4 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY:: Dyspnea (shortness of breath)
|
39.1%
9/23 • Number of events 10 • 4 years and 11 months
|
28.0%
7/25 • Number of events 9 • 4 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY:: Pleural effusion (non-malignant)
|
8.7%
2/23 • Number of events 2 • 4 years and 11 months
|
8.0%
2/25 • Number of events 5 • 4 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY:: Pulmonary-Other (Specify,___)
|
8.7%
2/23 • Number of events 3 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY:: Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
0.00%
0/25 • 4 years and 11 months
|
|
Renal and urinary disorders
RENAL/GENITOURINARY:: Creatinine
|
8.7%
2/23 • Number of events 2 • 4 years and 11 months
|
8.0%
2/25 • Number of events 3 • 4 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY:: Hypoxia
|
8.7%
2/23 • Number of events 2 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Renal and urinary disorders
RENAL/GENITOURINARY:: Urinary frequency/urgency
|
8.7%
2/23 • Number of events 2 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Immune system disorders
ALLERGY/IMMUNOLOGY:: Allergic reaction/hypersensitivity (including drug fever)
|
0.00%
0/23 • 4 years and 11 months
|
8.0%
2/25 • Number of events 3 • 4 years and 11 months
|
|
Immune system disorders
ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
34.8%
8/23 • Number of events 9 • 4 years and 11 months
|
12.0%
3/25 • Number of events 3 • 4 years and 11 months
|
|
Nervous system disorders
PAIN:: Headache
|
21.7%
5/23 • Number of events 5 • 4 years and 11 months
|
20.0%
5/25 • Number of events 6 • 4 years and 11 months
|
|
Immune system disorders
ALLERGY/IMMUNOLOGY:: Allergy-Other (Specify,_____)
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Investigations
BLOOD/BONE MARROW:: Hemoglobin
|
0.00%
0/23 • 4 years and 11 months
|
80.0%
20/25 • Number of events 72 • 4 years and 11 months
|
|
Cardiac disorders
CARDIOVASCULAR (ARRHYTHMIA):: Palpitations
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 2 • 4 years and 11 months
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Bruising (in absence of grade 3 or 4 thrombocytopenia)
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Pruritus
|
0.00%
0/23 • 4 years and 11 months
|
8.0%
2/25 • Number of events 2 • 4 years and 11 months
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN:: Wound-non-infectious
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL:: Mucositis due to radiation
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Blood and lymphatic system disorders
HEMORRHAGE:: CNS hemorrhage/bleeding
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Renal and urinary disorders
HEMORRHAGE:: Hematuria (in the absence of vaginal bleeding)
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 2 • 4 years and 11 months
|
|
Gastrointestinal disorders
HEMORRHAGE:: Rectal bleeding/hematochezia
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Infections and infestations
INFECTION/FEBRILE NEUTROPENIA:: Infection/Febrile Neutropenia-Other (Specify,____)
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Investigations
METABOLIC/LABORATORY:: Hyperuricemia
|
4.3%
1/23 • Number of events 1 • 4 years and 11 months
|
8.0%
2/25 • Number of events 3 • 4 years and 11 months
|
|
Nervous system disorders
NEUROLOGY:: Mood alteration-anxiety, agitation
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Eye disorders
OCULAR/VISUAL:: Ocular/Visual-Other (Specify,___)
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Eye disorders
OCULAR/VISUAL:: Vision-blurred vision
|
0.00%
0/23 • 4 years and 11 months
|
8.0%
2/25 • Number of events 2 • 4 years and 11 months
|
|
Ear and labyrinth disorders
PAIN:: Earache (otalgia)
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Reproductive system and breast disorders
PAIN:: Pelvic pain
|
0.00%
0/23 • 4 years and 11 months
|
4.0%
1/25 • Number of events 1 • 4 years and 11 months
|
|
Renal and urinary disorders
RENAL/GENITOURINARY:: Dysuria (painful urination)
|
0.00%
0/23 • 4 years and 11 months
|
8.0%
2/25 • Number of events 2 • 4 years and 11 months
|
|
Renal and urinary disorders
RENAL/GENITOURINARY:: Urinary retention
|
0.00%
0/23 • 4 years and 11 months
|
8.0%
2/25 • Number of events 2 • 4 years and 11 months
|
Additional Information
Susan E. Bates, M.D.
National Cancer Institute, National Institutes of Health
Phone: 301-402-1357
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place