Trial Outcomes & Findings for PF-00299804 in Stage IIIB or Stage IV Non-Small Cell Lung Cancer Not Responding to Standard Therapy for Advanced or Metastatic Cancer (NCT NCT01000025)
NCT ID: NCT01000025
Last Updated: 2023-08-22
Results Overview
Median and 95% confidence intervals
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
720 participants
Primary outcome timeframe
42 Months
Results posted on
2023-08-22
Participant Flow
Participant milestones
| Measure |
PF-804
Study treatment arm
|
Placebo
Control arm
|
|---|---|---|
|
Overall Study
STARTED
|
480
|
240
|
|
Overall Study
COMPLETED
|
12
|
2
|
|
Overall Study
NOT COMPLETED
|
468
|
238
|
Reasons for withdrawal
| Measure |
PF-804
Study treatment arm
|
Placebo
Control arm
|
|---|---|---|
|
Overall Study
Adverse Event
|
43
|
2
|
|
Overall Study
Withdrawal by Subject
|
13
|
8
|
|
Overall Study
Death
|
23
|
13
|
|
Overall Study
Lack of Efficacy
|
363
|
208
|
|
Overall Study
Intercurrent Illness
|
26
|
7
|
Baseline Characteristics
PF-00299804 in Stage IIIB or Stage IV Non-Small Cell Lung Cancer Not Responding to Standard Therapy for Advanced or Metastatic Cancer
Baseline characteristics by cohort
| Measure |
PF-00299804
n=480 Participants
Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PF-00299804: PF-804 45 mg PO, daily
|
Placebo
n=240 Participants
Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Placebo: Placebo 45 mg PO, daily
|
Total
n=720 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.5 years
n=5 Participants
|
65.5 years
n=7 Participants
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
236 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
356 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
244 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
364 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
172 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
259 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
288 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
432 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Philippines
|
20 participants
n=5 Participants
|
11 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
207 participants
n=5 Participants
|
101 participants
n=7 Participants
|
308 participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
28 participants
n=5 Participants
|
14 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
25 participants
n=5 Participants
|
14 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Region of Enrollment
Peru
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
50 participants
n=5 Participants
|
27 participants
n=7 Participants
|
77 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
77 participants
n=5 Participants
|
34 participants
n=7 Participants
|
111 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
47 participants
n=5 Participants
|
24 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 42 MonthsPopulation: ITT
Median and 95% confidence intervals
Outcome measures
| Measure |
PF-00299804
n=480 Participants
Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PF-00299804: PF-804 45 mg PO, daily
|
Placebo
n=240 Participants
Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Placebo: Placebo 45 mg PO, daily
|
|---|---|---|
|
Overall Survival
|
6.83 Months
Interval 6.08 to 7.49
|
6.31 Months
Interval 5.32 to 7.52
|
SECONDARY outcome
Timeframe: 42 MonthsPopulation: Patients with K-Ras mutation wild type
Median and 95% confidence intervals of Overall survival in KRAS-WT patients
Outcome measures
| Measure |
PF-00299804
n=220 Participants
Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PF-00299804: PF-804 45 mg PO, daily
|
Placebo
n=120 Participants
Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Placebo: Placebo 45 mg PO, daily
|
|---|---|---|
|
Overall Survival in KRAS-WT Patients
|
7.00 Months
Interval 6.01 to 8.21
|
5.19 Months
Interval 4.53 to 7.0
|
SECONDARY outcome
Timeframe: 42 MonthsPopulation: Patients with EGFR mutation
Overall survival by EGFR-mutantion subgroups
Outcome measures
| Measure |
PF-00299804
n=114 Participants
Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PF-00299804: PF-804 45 mg PO, daily
|
Placebo
n=68 Participants
Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Placebo: Placebo 45 mg PO, daily
|
|---|---|---|
|
Overall Survival in EGFR-mutant Patients
|
7.23 Months
Interval 6.08 to 8.61
|
7.52 Months
Interval 4.99 to 9.49
|
SECONDARY outcome
Timeframe: 42 MonthsPopulation: ITT
progression were evaluated using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee
Outcome measures
| Measure |
PF-00299804
n=480 Participants
Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PF-00299804: PF-804 45 mg PO, daily
|
Placebo
n=240 Participants
Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Placebo: Placebo 45 mg PO, daily
|
|---|---|---|
|
Progression-free Survival
|
2.66 Months
Interval 1.91 to 3.32
|
1.58 Months
Interval 0.99 to 1.74
|
SECONDARY outcome
Timeframe: 42 monthsPopulation: ITT
Response were evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee. BEST RESPONSE from the start of study treatment until the end of treatment were reported.Objective response rate is the sum of CR + PR divided by the total number of patients in each group.
Outcome measures
| Measure |
PF-00299804
n=480 Participants
Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PF-00299804: PF-804 45 mg PO, daily
|
Placebo
n=240 Participants
Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Placebo: Placebo 45 mg PO, daily
|
|---|---|---|
|
Objective Response Rate
|
7.1 percentage of participants
Interval 4.8 to 9.4
|
1.3 percentage of participants
Interval 0.0 to 2.7
|
SECONDARY outcome
Timeframe: 42 MonthsPopulation: As treated population
Number of participants with Toxicities by treatment received according to NCI CTCAE version 4.0
Outcome measures
| Measure |
PF-00299804
n=477 Participants
Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PF-00299804: PF-804 45 mg PO, daily
|
Placebo
n=239 Participants
Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Placebo: Placebo 45 mg PO, daily
|
|---|---|---|
|
Number of Participants With Toxicity as Measured by NCI CTCAE Version 4.0
|
467 participants
|
223 participants
|
Adverse Events
PF-00299804
Serious events: 191 serious events
Other events: 465 other events
Deaths: 0 deaths
Placebo
Serious events: 87 serious events
Other events: 219 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PF-00299804
n=477 participants at risk
Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PF-00299804: PF-804 45 mg PO, daily
|
Placebo
n=239 participants at risk
Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Placebo: Placebo 45 mg PO, daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.21%
1/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Cardiac disorders
Cardiac arrest
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Cardiac disorders
Myocardial infarction
|
0.21%
1/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Cardiac disorders
Pericardial effusion
|
0.21%
1/477 • 42 Months
|
0.84%
2/239 • 42 Months
|
|
Cardiac disorders
Pericardial tamponade
|
0.00%
0/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Cardiac disorders
Pericarditis
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Eye disorders
Cataract
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Eye disorders
Corneal ulcer
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.84%
4/477 • 42 Months
|
1.3%
3/239 • 42 Months
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Gastrointestinal disorders
Ascites
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Gastrointestinal disorders
Colitis
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Gastrointestinal disorders
Constipation
|
0.63%
3/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
17/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/477 • 42 Months
|
0.84%
2/239 • 42 Months
|
|
Gastrointestinal disorders
Esophageal stenosis
|
0.00%
0/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Gastrointestinal disorders
Mucositis oral
|
1.0%
5/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Gastrointestinal disorders
Nausea
|
1.0%
5/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
8/477 • 42 Months
|
1.3%
3/239 • 42 Months
|
|
General disorders
Chills
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
General disorders
Death NOS
|
0.42%
2/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
General disorders
Fatigue
|
0.84%
4/477 • 42 Months
|
0.84%
2/239 • 42 Months
|
|
General disorders
Fever
|
1.5%
7/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
General disorders
Gait disturbance
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
General disorders
Infusion site extravasation
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
General disorders
Non-cardiac chest pain
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
General disorders
Pain
|
0.42%
2/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
General disorders
Sudden death NOS
|
0.21%
1/477 • 42 Months
|
0.84%
2/239 • 42 Months
|
|
Hepatobiliary disorders
Hepatic failure
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Infections and infestations
Bronchial infection
|
0.21%
1/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Infections and infestations
Enterocolitis infectious
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Infections and infestations
Lung infection
|
6.7%
32/477 • 42 Months
|
5.0%
12/239 • 42 Months
|
|
Infections and infestations
Lymph gland infection
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Infections and infestations
Mucosal infection
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Infections and infestations
Other infections and infestations
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Infections and infestations
Scrotal infection
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Infections and infestations
Sepsis
|
0.42%
2/477 • 42 Months
|
1.3%
3/239 • 42 Months
|
|
Infections and infestations
Skin infection
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Infections and infestations
Urinary tract infection
|
0.42%
2/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Injury, poisoning and procedural complications
Fall
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Injury, poisoning and procedural complications
Fracture
|
0.63%
3/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.63%
3/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Investigations
Weight loss
|
0.00%
0/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.63%
3/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Metabolism and nutrition disorders
Dehydration
|
3.4%
16/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.42%
2/477 • 42 Months
|
0.84%
2/239 • 42 Months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.21%
1/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.42%
2/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.42%
2/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other neoplasms benign, malignant and unspecified
|
16.6%
79/477 • 42 Months
|
18.0%
43/239 • 42 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.42%
2/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Nervous system disorders
Depressed level of consciousness
|
0.84%
4/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Nervous system disorders
Dizziness
|
0.42%
2/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Nervous system disorders
Dysphasia
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Nervous system disorders
Encephalopathy
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Nervous system disorders
Other nervous system disorders
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Nervous system disorders
Seizure
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Nervous system disorders
Sinus pain
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Nervous system disorders
Stroke
|
0.42%
2/477 • 42 Months
|
1.3%
3/239 • 42 Months
|
|
Nervous system disorders
Syncope
|
0.00%
0/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Psychiatric disorders
Confusion
|
0.63%
3/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Psychiatric disorders
Personality change
|
0.00%
0/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
6/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
1.3%
6/477 • 42 Months
|
1.7%
4/239 • 42 Months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.5%
26/477 • 42 Months
|
5.9%
14/239 • 42 Months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.42%
2/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.84%
4/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
7/477 • 42 Months
|
1.3%
3/239 • 42 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.42%
2/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.42%
2/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.3%
6/477 • 42 Months
|
0.84%
2/239 • 42 Months
|
|
Skin and subcutaneous tissue disorders
Other skin and subcutaneous tissue disorders
|
0.42%
2/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.42%
2/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.21%
1/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Vascular disorders
Hypotension
|
0.00%
0/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Vascular disorders
Other vascular disorders
|
0.00%
0/477 • 42 Months
|
0.42%
1/239 • 42 Months
|
|
Vascular disorders
Thromboembolic event
|
2.5%
12/477 • 42 Months
|
1.3%
3/239 • 42 Months
|
Other adverse events
| Measure |
PF-00299804
n=477 participants at risk
Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PF-00299804: PF-804 45 mg PO, daily
|
Placebo
n=239 participants at risk
Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Placebo: Placebo 45 mg PO, daily
|
|---|---|---|
|
Eye disorders
Conjunctivitis
|
9.9%
47/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Eye disorders
Dry eye
|
8.6%
41/477 • 42 Months
|
2.1%
5/239 • 42 Months
|
|
Gastrointestinal disorders
Abdominal pain
|
12.8%
61/477 • 42 Months
|
7.5%
18/239 • 42 Months
|
|
Gastrointestinal disorders
Constipation
|
25.2%
120/477 • 42 Months
|
31.0%
74/239 • 42 Months
|
|
Gastrointestinal disorders
Diarrhea
|
79.7%
380/477 • 42 Months
|
19.7%
47/239 • 42 Months
|
|
Gastrointestinal disorders
Dry mouth
|
10.5%
50/477 • 42 Months
|
4.6%
11/239 • 42 Months
|
|
Gastrointestinal disorders
Dyspepsia
|
8.2%
39/477 • 42 Months
|
5.0%
12/239 • 42 Months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.3%
30/477 • 42 Months
|
3.8%
9/239 • 42 Months
|
|
Gastrointestinal disorders
Mucositis oral
|
43.2%
206/477 • 42 Months
|
3.3%
8/239 • 42 Months
|
|
Gastrointestinal disorders
Nausea
|
35.2%
168/477 • 42 Months
|
24.7%
59/239 • 42 Months
|
|
Gastrointestinal disorders
Vomiting
|
28.1%
134/477 • 42 Months
|
15.5%
37/239 • 42 Months
|
|
General disorders
Edema limbs
|
11.9%
57/477 • 42 Months
|
11.7%
28/239 • 42 Months
|
|
General disorders
Fatigue
|
53.2%
254/477 • 42 Months
|
48.1%
115/239 • 42 Months
|
|
General disorders
Fever
|
8.8%
42/477 • 42 Months
|
6.3%
15/239 • 42 Months
|
|
General disorders
Non-cardiac chest pain
|
6.9%
33/477 • 42 Months
|
8.8%
21/239 • 42 Months
|
|
General disorders
Pain
|
19.5%
93/477 • 42 Months
|
20.9%
50/239 • 42 Months
|
|
Infections and infestations
Lung infection
|
5.2%
25/477 • 42 Months
|
2.5%
6/239 • 42 Months
|
|
Infections and infestations
Paronychia
|
29.8%
142/477 • 42 Months
|
0.00%
0/239 • 42 Months
|
|
Investigations
Weight loss
|
15.3%
73/477 • 42 Months
|
9.6%
23/239 • 42 Months
|
|
Metabolism and nutrition disorders
Anorexia
|
46.5%
222/477 • 42 Months
|
38.9%
93/239 • 42 Months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.4%
83/477 • 42 Months
|
19.7%
47/239 • 42 Months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.1%
48/477 • 42 Months
|
8.4%
20/239 • 42 Months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
8.6%
41/477 • 42 Months
|
11.3%
27/239 • 42 Months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.6%
79/477 • 42 Months
|
14.6%
35/239 • 42 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
6.5%
31/477 • 42 Months
|
5.4%
13/239 • 42 Months
|
|
Nervous system disorders
Dizziness
|
11.5%
55/477 • 42 Months
|
10.5%
25/239 • 42 Months
|
|
Nervous system disorders
Dysgeusia
|
7.1%
34/477 • 42 Months
|
1.7%
4/239 • 42 Months
|
|
Nervous system disorders
Headache
|
11.1%
53/477 • 42 Months
|
12.1%
29/239 • 42 Months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
17.6%
84/477 • 42 Months
|
13.4%
32/239 • 42 Months
|
|
Psychiatric disorders
Anxiety
|
6.3%
30/477 • 42 Months
|
8.4%
20/239 • 42 Months
|
|
Psychiatric disorders
Insomnia
|
17.6%
84/477 • 42 Months
|
18.8%
45/239 • 42 Months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
5.2%
25/477 • 42 Months
|
5.9%
14/239 • 42 Months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
48.8%
233/477 • 42 Months
|
45.2%
108/239 • 42 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
57.9%
276/477 • 42 Months
|
55.2%
132/239 • 42 Months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
15.1%
72/477 • 42 Months
|
1.7%
4/239 • 42 Months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
12.2%
58/477 • 42 Months
|
13.4%
32/239 • 42 Months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.5%
26/477 • 42 Months
|
1.3%
3/239 • 42 Months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.2%
25/477 • 42 Months
|
4.6%
11/239 • 42 Months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
35.8%
171/477 • 42 Months
|
11.3%
27/239 • 42 Months
|
|
Skin and subcutaneous tissue disorders
Other skin and subcutaneous tissue disorders
|
6.3%
30/477 • 42 Months
|
2.1%
5/239 • 42 Months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
11.5%
55/477 • 42 Months
|
0.84%
2/239 • 42 Months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.2%
87/477 • 42 Months
|
11.7%
28/239 • 42 Months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
59.3%
283/477 • 42 Months
|
10.0%
24/239 • 42 Months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.4%
78/477 • 42 Months
|
6.7%
16/239 • 42 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place