Trial Outcomes & Findings for Pemetrexed as Second-Line Therapy in Treating Patients With Hormone Refractory Prostate Cancer (NCT NCT00216099)
NCT ID: NCT00216099
Last Updated: 2016-07-29
Results Overview
Best overall Prostate-Specific Antigen (PSA) response PSA response is defined by a greater than or equal to 50% decline in PSA confirmed by a second PSA value at least 4 weeks after the first PSA response timepoint PSA Stable Disease is defined as less than a 50% decline in PSA and less than a 50% increase in PSA from baseline PSA progression is defined as greater than or equal to a 50% increase in PSA compared to baseline
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
Start of treatment until disease progression/recurrence (for life)
Results posted on
2016-07-29
Participant Flow
Participant milestones
| Measure |
Pemetrexed 500mg/m^2
Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
Toxicity Analysis
|
49
|
|
Overall Study
Response Analysis
|
48
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pemetrexed as Second-Line Therapy in Treating Patients With Hormone Refractory Prostate Cancer
Baseline characteristics by cohort
| Measure |
Pemetrexed 500mg/m^2
n=49 Participants
Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
|
|---|---|
|
Age, Continuous
|
68 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=39 Participants
|
|
Baseline Prostate-Specific Antigen (PSA)
|
72.2 ng/mL
n=39 Participants
|
|
Baseline Karnofsky Performance Status (KPS)
|
90 units on a scale
n=39 Participants
|
|
Baseline Pain Score
|
2 units on a scale
n=39 Participants
|
|
Baseline Opiate Use
|
9.6 Intramuscular morphine equivalents
n=39 Participants
|
|
Metastatic Sites
Bone
|
31 participants
n=39 Participants
|
|
Metastatic Sites
Lymph Node
|
16 participants
n=39 Participants
|
|
Metastatic Sites
Visceral
|
7 participants
n=39 Participants
|
|
Days Since Last Docetaxel
0-28
|
30 participants
n=39 Participants
|
|
Days Since Last Docetaxel
29-90
|
7 participants
n=39 Participants
|
|
Days Since Last Docetaxel
91-180
|
5 participants
n=39 Participants
|
|
Days Since Last Docetaxel
>180
|
6 participants
n=39 Participants
|
|
Days Since Last Docetaxel
unknown
|
1 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Start of treatment until disease progression/recurrence (for life)Best overall Prostate-Specific Antigen (PSA) response PSA response is defined by a greater than or equal to 50% decline in PSA confirmed by a second PSA value at least 4 weeks after the first PSA response timepoint PSA Stable Disease is defined as less than a 50% decline in PSA and less than a 50% increase in PSA from baseline PSA progression is defined as greater than or equal to a 50% increase in PSA compared to baseline
Outcome measures
| Measure |
Pemetrexed 500mg/m^2
n=49 Participants
Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
|
|---|---|
|
Best Overall PSA Response
>50% decline in PSA
|
8 percentage of participatns
Interval 1.0 to 16.0
|
|
Best Overall PSA Response
Stable PSA
|
20 percentage of participatns
Interval 9.0 to 32.0
|
|
Best Overall PSA Response
PSA progression
|
65 percentage of participatns
Interval 52.0 to 79.0
|
SECONDARY outcome
Timeframe: From study enrollment until death (for life)Outcome measures
| Measure |
Pemetrexed 500mg/m^2
n=48 Participants
Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
|
|---|---|
|
Overall Survival
|
14 months
Interval 13.0 to 19.0
|
SECONDARY outcome
Timeframe: Start of treatment until disease progression/recurrence (for life)Population: Patients who had measurable disease per RECIST 1.1 at baseline. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension with longest diameter \>20 mm using conventional techniques or \>10 mm with spiral CT scan.
Response Evaluation Criteria in Solid Tumors (RECIST). Objective overall response rate is defined as Complete Response (CR) + Partial Response (PR) Per RECIST: CR= Disappearance of all target and non-target lesions and normalization of tumor marker level PR= Disappearance of all target lesions and persistence of non-target lesion(s) or maintenance of tumor marker level above normal limits OR at least a 30% decrease in the sum of the longest diameter, taking as reference the baseline sum longest diameter and disappearance of all non-target lesions or persistence of non-target lesion(s) or maintenance of tumor marker level above normal limits
Outcome measures
| Measure |
Pemetrexed 500mg/m^2
n=26 Participants
Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
|
|---|---|
|
OBJECTIVE Overall Response Rate
Participants with PR with meas. dis. per RECIST
|
8 percentage of participants
Interval 1.0 to 25.0
|
|
OBJECTIVE Overall Response Rate
participants with SD maintained at 12 weeks
|
39 percentage of participants
Interval 20.0 to 59.0
|
SECONDARY outcome
Timeframe: Any time among evaluable subjects (for life)A clinical benefit is defined as an improvement for at least 3 consecutive weeks in at least one of the following parameters without any sustained worsening in any other: \> 50% reduction in analgesic consumption or \> 50% reduction in pain intensity or \> 20 point gain in performance status.
Outcome measures
| Measure |
Pemetrexed 500mg/m^2
n=48 Participants
Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
|
|---|---|
|
Rate of Clinical Benefit
|
33 percentage of participants
Interval 20.0 to 48.0
|
SECONDARY outcome
Timeframe: 18 monthsSafety and Tolerability was evaluated by reporting the percentage of patient who experienced grade 3 or 4 toxicities using Common Terminology Criteria for Adverse Events CTCAE v3.0 criteria. CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
Outcome measures
| Measure |
Pemetrexed 500mg/m^2
n=49 Participants
Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
|
|---|---|
|
Safety and Tolerability
Grade 3
|
42.9 percentage of participants
Interval 27.0 to 55.8
|
|
Safety and Tolerability
Grade 4
|
8.2 percentage of participants
Interval 2.3 to 19.6
|
SECONDARY outcome
Timeframe: ScreeningPopulation: Samples were available from 46 patients
Samples for RFC1 G80A pharmacogenetic analysis were collected at screening
Outcome measures
| Measure |
Pemetrexed 500mg/m^2
n=46 Participants
Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
|
|---|---|
|
RFC1 G80A Genotype
A/A Genotype
|
6 participants
|
|
RFC1 G80A Genotype
A/G Genotype
|
22 participants
|
|
RFC1 G80A Genotype
G/G Genotype
|
18 participants
|
SECONDARY outcome
Timeframe: Study enrollment until progression per RECIST or PSA (for life)Progression per Response Evaluation Criteria in Solid Tumors (RECIST) or Prostate-Specific Antigen (PSA) Progression RECIST PD=at least a 20% increase in the sum of the longest diameter (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 or Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions PSA progression=increase in PSA to \>50% above lowest level recorded on study. Two consecutive increases required at least 4 weeks apart, but time to progression will be determined at time of first PSA showing increase \> 50% above baseline \*Note, upper confidence interval was not reached\*
Outcome measures
| Measure |
Pemetrexed 500mg/m^2
n=48 Participants
Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
|
|---|---|
|
Time to Progression
|
5 months
Interval 1.0 to
The upper confidence interval was not reached.
|
SECONDARY outcome
Timeframe: From study enrollment to progression per PSA criteria (for life)Serological Progression (sPD) - increase in PSA to \>50% above lowest level recorded on study. Two consecutive increases required at least 4 weeks apart, but time to progression will be determined at time of first PSA showing increase \> 50% above baseline
Outcome measures
| Measure |
Pemetrexed 500mg/m^2
n=48 Participants
Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
|
|---|---|
|
Time to Prostate-Specific Antigen (PSA)/Serological Progression
|
2 months
Interval 1.0 to 5.0
|
Adverse Events
Pemetrexed 500mg/m^2
Serious events: 15 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed 500mg/m^2
n=49 participants at risk
Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
|
|---|---|
|
Nervous system disorders
CONFUSION
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Gastrointestinal disorders
DEHYDRATION
|
4.1%
2/49 • Number of events 2 • Duration of Treatment
|
|
Gastrointestinal disorders
DIARRHEA
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Blood and lymphatic system disorders
DIC (DISSEMINATED INTRAVASCULAR COAGULATION)
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Infections and infestations
FEBRILE NEUTROPENIA(ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Nervous system disorders
HEMORRHAGE, CNS
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Hepatobiliary disorders
HEPATOBILIARY/PANCREAS - OTHER
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Infections and infestations
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / CATHETER-RELATED
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / URINARY TRACT NOS
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / SKIN (CELLULITES)
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / URINARY TRACT NOS
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Musculoskeletal and connective tissue disorders
PAIN / BONE
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Cardiac disorders
PAIN / CARDIAC/HEART
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
General disorders
PAIN / PELVIS
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Blood and lymphatic system disorders
PLATELETS
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Vascular disorders
VESSEL INJURY-ARTERY / EXTREMITY-LOWER
|
2.0%
1/49 • Number of events 2 • Duration of Treatment
|
|
Vascular disorders
VESSEL INJURY-VEIN / EXTREMITY-LOWER
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
Other adverse events
| Measure |
Pemetrexed 500mg/m^2
n=49 participants at risk
Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
|
|---|---|
|
Investigations
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Investigations
ALKALINE PHOSPHATASE
|
14.3%
7/49 • Number of events 8 • Duration of Treatment
|
|
Immune system disorders
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Immune system disorders
ALLERGY/IMMUNOLOGY - OTHER
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
|
12.2%
6/49 • Number of events 7 • Duration of Treatment
|
|
Gastrointestinal disorders
ANOREXIA
|
34.7%
17/49 • Number of events 32 • Duration of Treatment
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS (NON-SEPTIC)
|
4.1%
2/49 • Number of events 2 • Duration of Treatment
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
10.2%
5/49 • Number of events 7 • Duration of Treatment
|
|
Cardiac disorders
CARDIAC ARRHYTHMIA - OTHER
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Cardiac disorders
CARDIAC GENERAL - OTHER
|
4.1%
2/49 • Number of events 2 • Duration of Treatment
|
|
Nervous system disorders
COGNITIVE DISTURBANCE
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Nervous system disorders
CONFUSION
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Gastrointestinal disorders
CONSTIPATION
|
20.4%
10/49 • Number of events 17 • Duration of Treatment
|
|
General disorders
CONSTITUTIONAL SYMPTOMS - OTHER
|
8.2%
4/49 • Number of events 4 • Duration of Treatment
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
28.6%
14/49 • Number of events 15 • Duration of Treatment
|
|
Investigations
CREATININE
|
14.3%
7/49 • Number of events 10 • Duration of Treatment
|
|
Gastrointestinal disorders
DEHYDRATION
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN - OTHER
|
4.1%
2/49 • Number of events 3 • Duration of Treatment
|
|
Gastrointestinal disorders
DIARRHEA
|
26.5%
13/49 • Number of events 18 • Duration of Treatment
|
|
Gastrointestinal disorders
DISTENSION/BLOATING, ABDOMINAL
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Nervous system disorders
DIZZINESS
|
4.1%
2/49 • Number of events 3 • Duration of Treatment
|
|
Gastrointestinal disorders
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
26.5%
13/49 • Number of events 21 • Duration of Treatment
|
|
Blood and lymphatic system disorders
EDEMA: LIMB
|
24.5%
12/49 • Number of events 15 • Duration of Treatment
|
|
Blood and lymphatic system disorders
EDEMA: TRUNK/GENITAL
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Nervous system disorders
EXTRAPYRAMIDAL/INVOLUNTARY MOVEMENT/RESTLESSNESS
|
4.1%
2/49 • Number of events 2 • Duration of Treatment
|
|
Musculoskeletal and connective tissue disorders
EXTREMITY-LOWER (GAIT/WALKING)
|
6.1%
3/49 • Number of events 3 • Duration of Treatment
|
|
Musculoskeletal and connective tissue disorders
EXTREMITY-UPPER (FUNCTION)
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
83.7%
41/49 • Number of events 65 • Duration of Treatment
|
|
Infections and infestations
FEBRILE NEUTROPENIA (ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)
|
4.1%
2/49 • Number of events 2 • Duration of Treatment
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
18.4%
9/49 • Number of events 20 • Duration of Treatment
|
|
Skin and subcutaneous tissue disorders
FLUSHING
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Gastrointestinal disorders
GASTROINTESTINAL - OTHER
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Investigations
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
|
6.1%
3/49 • Number of events 3 • Duration of Treatment
|
|
Reproductive system and breast disorders
GYNECOMASTIA
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS/ALOPECIA (SCALP OR BODY)
|
18.4%
9/49 • Number of events 9 • Duration of Treatment
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
22.4%
11/49 • Number of events 12 • Duration of Treatment
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
42.9%
21/49 • Number of events 44 • Duration of Treatment
|
|
Investigations
HEMOGLOBINURIA
|
2.0%
1/49 • Number of events 3 • Duration of Treatment
|
|
Gastrointestinal disorders
HEMORRHAGE, GI
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Gastrointestinal disorders
HEMORRHAGE, GI / ANUS
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / NOSE
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Endocrine disorders
HOT FLASHES/FLUSHES
|
12.2%
6/49 • Number of events 6 • Duration of Treatment
|
|
Cardiac disorders
HYPERTENSION
|
6.1%
3/49 • Number of events 3 • Duration of Treatment
|
|
Cardiac disorders
HYPOTENSION
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Renal and urinary disorders
INCONTINENCE, URINARY
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Infections and infestations
INFECTION - OTHER
|
10.2%
5/49 • Number of events 5 • Duration of Treatment
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / BLADDER (URINARY)
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA)
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SKIN (CELLULITIS)
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / ABDOMEN NOS
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / BLADDER (URINARY)
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / LYMPHATIC
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / SKIN (CELLULITES)
|
2.0%
1/49 • Number of events 2 • Duration of Treatment
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / UPPER AIRWAY NOS
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / URINARY TRACT NOS
|
8.2%
4/49 • Number of events 8 • Duration of Treatment
|
|
Surgical and medical procedures
INR (INTERNATIONAL NORMALIZED RATIO OF PROTHROMBIN TIME)
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
General disorders
INSOMNIA
|
26.5%
13/49 • Number of events 15 • Duration of Treatment
|
|
Blood and lymphatic system disorders
LEUKOCYTES (TOTAL WBC)
|
8.2%
4/49 • Number of events 13 • Duration of Treatment
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINE-RANGE OF MOTION
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Blood and lymphatic system disorders
LYMPHATICS - OTHER
|
2.0%
1/49 • Number of events 4 • Duration of Treatment
|
|
Psychiatric disorders
MOOD ALTERATION / AGITATION
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Psychiatric disorders
MOOD ALTERATION / ANXIETY
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Psychiatric disorders
MOOD ALTERATION / DEPRESSION
|
16.3%
8/49 • Number of events 9 • Duration of Treatment
|
|
Surgical and medical procedures
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY
|
8.2%
4/49 • Number of events 4 • Duration of Treatment
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY
|
4.1%
2/49 • Number of events 2 • Duration of Treatment
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ORAL CAVITY
|
10.2%
5/49 • Number of events 5 • Duration of Treatment
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-LOWER
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / WHOLE BODY/GENERALIZED
|
6.1%
3/49 • Number of events 3 • Duration of Treatment
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL/SOFT TISSUE - OTHER
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Skin and subcutaneous tissue disorders
NAIL CHANGES
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CAVITY/PARANASAL SINUS REACTIONS
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Gastrointestinal disorders
NAUSEA
|
44.9%
22/49 • Number of events 34 • Duration of Treatment
|
|
Nervous system disorders
NEUROLOGY - OTHER
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Nervous system disorders
NEUROPATHY: MOTOR
|
10.2%
5/49 • Number of events 5 • Duration of Treatment
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
22.4%
11/49 • Number of events 12 • Duration of Treatment
|
|
Blood and lymphatic system disorders
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
6.1%
3/49 • Number of events 4 • Duration of Treatment
|
|
Reproductive system and breast disorders
OBSTRUCTION, GU / PROSTATE
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Eye disorders
OCULAR/VISUAL - OTHER
|
4.1%
2/49 • Number of events 3 • Duration of Treatment
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Gastrointestinal disorders
PAIN / ABDOMEN NOS
|
6.1%
3/49 • Number of events 3 • Duration of Treatment
|
|
General disorders
PAIN / BACK
|
4.1%
2/49 • Number of events 2 • Duration of Treatment
|
|
Renal and urinary disorders
PAIN / BLADDER
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Musculoskeletal and connective tissue disorders
PAIN / BONE
|
16.3%
8/49 • Number of events 12 • Duration of Treatment
|
|
Reproductive system and breast disorders
PAIN / BREAST
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST/THORAX NOS
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Musculoskeletal and connective tissue disorders
PAIN / EXTREMITY-LIMB
|
18.4%
9/49 • Number of events 11 • Duration of Treatment
|
|
General disorders
PAIN / EXTREMITY-LIMB- HAND
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Eye disorders
PAIN / EYE
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
General disorders
PAIN / HEAD/HEADACHE
|
4.1%
2/49 • Number of events 2 • Duration of Treatment
|
|
Gastrointestinal disorders
PAIN / INTESTINE
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Musculoskeletal and connective tissue disorders
PAIN / JOINT
|
8.2%
4/49 • Number of events 5 • Duration of Treatment
|
|
Musculoskeletal and connective tissue disorders
PAIN / MUSCLE
|
4.1%
2/49 • Number of events 2 • Duration of Treatment
|
|
Nervous system disorders
PAIN / NEURALGIA/PERIPHERAL NERVE
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Gastrointestinal disorders
PAIN / ORAL CAVITY
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
General disorders
PAIN / PERINEUM
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Reproductive system and breast disorders
PAIN / PROSTATE
|
2.0%
1/49 • Number of events 3 • Duration of Treatment
|
|
Gastrointestinal disorders
PAIN / RECTUM
|
2.0%
1/49 • Number of events 2 • Duration of Treatment
|
|
General disorders
PAIN / SCALP
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Gastrointestinal disorders
PAIN / STOMACH
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
General disorders
PAIN - OTHER
|
10.2%
5/49 • Number of events 7 • Duration of Treatment
|
|
General disorders
PAIN - OTHER FEET
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
General disorders
PAIN / EXTREMITY-LIMB
|
4.1%
2/49 • Number of events 3 • Duration of Treatment
|
|
General disorders
PAIN / PELVIS
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Hepatobiliary disorders
PANCREATITIS
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Gastrointestinal disorders
PETECHIAE/PURPURA (HEMORRHAGE/BLEEDING INTO SKIN OR MUCOSA)
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Vascular disorders
PETECHIAE/PURPURA (HEMORRHAGE/BLEEDING INTO SKIN OR MUCOSA)
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Blood and lymphatic system disorders
PLATELETS
|
12.2%
6/49 • Number of events 9 • Duration of Treatment
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
18.4%
9/49 • Number of events 11 • Duration of Treatment
|
|
Surgical and medical procedures
PTT (PARTIAL THROMBOPLASTIN TIME)
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER
|
4.1%
2/49 • Number of events 2 • Duration of Treatment
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
12.2%
6/49 • Number of events 7 • Duration of Treatment
|
|
Skin and subcutaneous tissue disorders
RASH: ACNE/ACNEIFORM
|
16.3%
8/49 • Number of events 13 • Duration of Treatment
|
|
Skin and subcutaneous tissue disorders
RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS)
|
6.1%
3/49 • Number of events 3 • Duration of Treatment
|
|
Skin and subcutaneous tissue disorders
RASH: HAND-FOOT SKIN REACTION
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Renal and urinary disorders
RENAL/GENITOURINARY - OTHER
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
General disorders
RIGORS/CHILLS
|
6.1%
3/49 • Number of events 3 • Duration of Treatment
|
|
Investigations
SODIUM, SERUM-LOW (HYPONATREMIA)
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FIBRILLATION
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Gastrointestinal disorders
TASTE ALTERATION (DYSGEUSIA)
|
12.2%
6/49 • Number of events 8 • Duration of Treatment
|
|
Renal and urinary disorders
URINARY FREQUENCY/URGENCY
|
8.2%
4/49 • Number of events 5 • Duration of Treatment
|
|
Renal and urinary disorders
URINARY RETENTION (INCLUDING NEUROGENIC BLADDER)
|
4.1%
2/49 • Number of events 2 • Duration of Treatment
|
|
Renal and urinary disorders
URINE COLOR CHANGE
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Eye disorders
VISION-BLURRED VISION
|
2.0%
1/49 • Number of events 1 • Duration of Treatment
|
|
Gastrointestinal disorders
VOMITING
|
22.4%
11/49 • Number of events 16 • Duration of Treatment
|
|
Eye disorders
WATERY EYE (EPIPHORA, TEARING)
|
18.4%
9/49 • Number of events 10 • Duration of Treatment
|
|
General disorders
WEIGHT LOSS
|
6.1%
3/49 • Number of events 3 • Duration of Treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place