Trial Outcomes & Findings for GW786034 in Patients With Non Small Cell Lung Cancer 3rd Line (NCT NCT01049776)
NCT ID: NCT01049776
Last Updated: 2014-09-19
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions: Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesion, taking as reference the baseline sum of the longest diameter: Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, taking as reference the smallest sum Longest Diameter since the treatment started
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
12 weeks
Results posted on
2014-09-19
Participant Flow
Participant milestones
| Measure |
Pazapanib (GW786034)
Pazopanib (GW786034): Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GW786034 in Patients With Non Small Cell Lung Cancer 3rd Line
Baseline characteristics by cohort
| Measure |
Pazapanib (GW786034)
n=32 Participants
Pazopanib (GW786034): Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions: Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesion, taking as reference the baseline sum of the longest diameter: Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, taking as reference the smallest sum Longest Diameter since the treatment started
Outcome measures
| Measure |
Pazapanib (GW786034)
n=32 Participants
Pazopanib (GW786034): Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
|
|---|---|
|
Proportion of Non Small Cell Lung Cancer Participants With Disease Control (Complete Response+Partial Response+Stable Disease) Based on RECIST 1.0 Measured by CT or MRI
|
0.38 Proportion of participants
Interval 0.21 to 0.56
|
SECONDARY outcome
Timeframe: after the first 6 patients and quarterlyOutcome measures
Outcome data not reported
Adverse Events
Pazapanib (GW786034)
Serious events: 11 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pazapanib (GW786034)
n=32 participants at risk
Pazopanib (GW786034): Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
|
|---|---|
|
General disorders
Death
|
18.8%
6/32
|
|
Gastrointestinal disorders
Mucositis oral
|
3.1%
1/32
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
3.1%
1/32
|
|
Infections and infestations
Upper respiratory infection
|
6.2%
2/32
|
|
Gastrointestinal disorders
Ileus
|
3.1%
1/32
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
3.1%
1/32
|
Other adverse events
| Measure |
Pazapanib (GW786034)
n=32 participants at risk
Pazopanib (GW786034): Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
|
|---|---|
|
Immune system disorders
Allergic Rhinitis
|
18.8%
6/32
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow- AML
|
3.1%
1/32
|
|
Blood and lymphatic system disorders
Hemoglobin
|
68.8%
22/32
|
|
Blood and lymphatic system disorders
Leukocytes
|
34.4%
11/32
|
|
Blood and lymphatic system disorders
Lymphopenia
|
78.1%
25/32
|
|
Blood and lymphatic system disorders
Neutrophils
|
15.6%
5/32
|
|
Blood and lymphatic system disorders
Platelets
|
59.4%
19/32
|
|
Cardiac disorders
Cardiac Arrythmia- Systolic Anterior Motion
|
3.1%
1/32
|
|
Cardiac disorders
Cardiac Troponin I
|
9.4%
3/32
|
|
Cardiac disorders
Hypertension
|
68.8%
22/32
|
|
Cardiac disorders
Hypotension
|
15.6%
5/32
|
|
Cardiac disorders
Left Ventricular Systolic Dysfunction (LVSD)
|
3.1%
1/32
|
|
Cardiac disorders
Mitral Regurgitation
|
3.1%
1/32
|
|
Cardiac disorders
Prolonged QTc Interval
|
12.5%
4/32
|
|
Cardiac disorders
Supraventricular and Nodal Arrhthymia- Atrial Fibrillation
|
6.2%
2/32
|
|
Cardiac disorders
Supraventricular and Nodal Arrhthymia- Sinus Bradycardia
|
15.6%
5/32
|
|
Cardiac disorders
Supraventricular and Nodal Arrhthymia- Sinus Tachycardi
|
9.4%
3/32
|
|
Cardiac disorders
Ventricular Arrythmia- PVCs
|
3.1%
1/32
|
|
Blood and lymphatic system disorders
INR
|
12.5%
4/32
|
|
Blood and lymphatic system disorders
PTT
|
9.4%
3/32
|
|
General disorders
Fatigue
|
100.0%
32/32
|
|
Infections and infestations
Fever
|
9.4%
3/32
|
|
General disorders
Insomnia
|
18.8%
6/32
|
|
General disorders
Rigors/Chills
|
18.8%
6/32
|
|
General disorders
Sweating
|
9.4%
3/32
|
|
General disorders
Weight Loss
|
43.8%
14/32
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
12.5%
4/32
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
9.4%
3/32
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
37.5%
12/32
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
3.1%
1/32
|
|
Endocrine disorders
Hot Flashes/Flushes
|
3.1%
1/32
|
|
Endocrine disorders
Thyroid Function, low
|
28.1%
9/32
|
|
Endocrine disorders
Thyroid Function, high
|
6.2%
2/32
|
|
Gastrointestinal disorders
Anorexia
|
50.0%
16/32
|
|
Gastrointestinal disorders
Colitis
|
3.1%
1/32
|
|
Gastrointestinal disorders
Constipation
|
37.5%
12/32
|
|
Gastrointestinal disorders
Dehydration
|
25.0%
8/32
|
|
Gastrointestinal disorders
Diarrhea
|
75.0%
24/32
|
|
Gastrointestinal disorders
Dry Mouth/Salivary Gland
|
12.5%
4/32
|
|
Gastrointestinal disorders
Dysphagia
|
3.1%
1/32
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
2/32
|
|
Gastrointestinal disorders
Heartburn/Dyspepsia
|
12.5%
4/32
|
|
Gastrointestinal disorders
Mucositis
|
9.4%
3/32
|
|
Gastrointestinal disorders
Nausea
|
78.1%
25/32
|
|
Gastrointestinal disorders
Taste Alteration
|
15.6%
5/32
|
|
Gastrointestinal disorders
Vomiting
|
46.9%
15/32
|
|
Gastrointestinal disorders
Esophagitis
|
3.1%
1/32
|
|
Gastrointestinal disorders
Distention/Bloating- Abdominal
|
3.1%
1/32
|
|
Gastrointestinal disorders
Hemorrhage, GI- Lower GI NOS
|
6.2%
2/32
|
|
General disorders
Hemorrhage, GU- Urinary NOS
|
12.5%
4/32
|
|
General disorders
Hemorrhage, Pulmonary/Upper Respiratory- Nose
|
12.5%
4/32
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, Pulmonary/Upper Respiratory- Respiratory Tract NOS
|
6.2%
2/32
|
|
Hepatobiliary disorders
Liver Dysfunction/Failure
|
12.5%
4/32
|
|
Hepatobiliary disorders
Infection- Blood
|
6.2%
2/32
|
|
Hepatobiliary disorders
Infection- Bronchitis
|
9.4%
3/32
|
|
Hepatobiliary disorders
Infection- Lung (Pneumonia)
|
12.5%
4/32
|
|
Hepatobiliary disorders
Infection- Respiratory Tract NOS
|
6.2%
2/32
|
|
Hepatobiliary disorders
Infection- Sinus
|
9.4%
3/32
|
|
Hepatobiliary disorders
Infection- Skin
|
3.1%
1/32
|
|
Hepatobiliary disorders
Infection- Stomach
|
3.1%
1/32
|
|
Hepatobiliary disorders
Infection- Thrush
|
9.4%
3/32
|
|
Hepatobiliary disorders
Infection- Wound
|
3.1%
1/32
|
|
Hepatobiliary disorders
Infection- Upper Respiratory
|
6.2%
2/32
|
|
Hepatobiliary disorders
Infection- Urinary Tract
|
15.6%
5/32
|
|
Hepatobiliary disorders
Infection- Upper Airway NOS
|
3.1%
1/32
|
|
Hepatobiliary disorders
Infection- Oral Cavity
|
3.1%
1/32
|
|
Blood and lymphatic system disorders
Edema: Limb
|
15.6%
5/32
|
|
Blood and lymphatic system disorders
Albumin, serum- low
|
56.2%
18/32
|
|
Blood and lymphatic system disorders
Alkaline Phosphatase
|
43.8%
14/32
|
|
Blood and lymphatic system disorders
ALT (SGPT)
|
37.5%
12/32
|
|
Blood and lymphatic system disorders
AST (SGOT)
|
59.4%
19/32
|
|
Blood and lymphatic system disorders
Bilirubin
|
37.5%
12/32
|
|
Blood and lymphatic system disorders
Calcium, serum- high
|
3.1%
1/32
|
|
Blood and lymphatic system disorders
Calcium, serum- low
|
46.9%
15/32
|
|
Blood and lymphatic system disorders
Creatinine
|
28.1%
9/32
|
|
Blood and lymphatic system disorders
Glomerular Filtration Rate
|
18.8%
6/32
|
|
Blood and lymphatic system disorders
Glucose, serum- high
|
53.1%
17/32
|
|
Blood and lymphatic system disorders
Glucose, serum- low
|
12.5%
4/32
|
|
Blood and lymphatic system disorders
Lipase
|
3.1%
1/32
|
|
Blood and lymphatic system disorders
Magnesium, serum- high
|
6.2%
2/32
|
|
Blood and lymphatic system disorders
Magnesium, serum- low
|
28.1%
9/32
|
|
Blood and lymphatic system disorders
Phosphate, serum- low
|
15.6%
5/32
|
|
Blood and lymphatic system disorders
Potassium, serum- high
|
21.9%
7/32
|
|
Blood and lymphatic system disorders
Potassium, serum- low
|
31.2%
10/32
|
|
Blood and lymphatic system disorders
Proteinuria
|
50.0%
16/32
|
|
Blood and lymphatic system disorders
Sodium, serum- high
|
6.2%
2/32
|
|
Blood and lymphatic system disorders
Sodium, serum- low
|
68.8%
22/32
|
|
Blood and lymphatic system disorders
Triglyceride, serum- high
|
6.2%
2/32
|
|
Blood and lymphatic system disorders
Bicarbonate, serum low
|
3.1%
1/32
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.1%
1/32
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness- generalized
|
25.0%
8/32
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness- upper extremity
|
6.2%
2/32
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue- Leg Cramps
|
3.1%
1/32
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue- Muscle Spasms
|
3.1%
1/32
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue- Plantar Fasciitis
|
3.1%
1/32
|
|
Nervous system disorders
Ataxia
|
3.1%
1/32
|
|
Nervous system disorders
Confusion
|
15.6%
5/32
|
|
Nervous system disorders
Dizziness
|
31.2%
10/32
|
|
Nervous system disorders
Laryngeal Nerve Dysfunction
|
3.1%
1/32
|
|
Nervous system disorders
Mood Alteration- Anxiety
|
12.5%
4/32
|
|
Nervous system disorders
Neurology- Tremors
|
6.2%
2/32
|
|
Nervous system disorders
Neuropathy: Motor
|
12.5%
4/32
|
|
Nervous system disorders
Neuropathy: Sensory
|
50.0%
16/32
|
|
Nervous system disorders
Seizure
|
3.1%
1/32
|
|
Nervous system disorders
Syncope (Fainting)
|
3.1%
1/32
|
|
Nervous system disorders
Mood Alteration- Depression
|
6.2%
2/32
|
|
Nervous system disorders
Somnolence/Depressed Level of Consciousness
|
3.1%
1/32
|
|
Nervous system disorders
Apnea
|
3.1%
1/32
|
|
Eye disorders
Vision- Blurred Vision
|
18.8%
6/32
|
|
Eye disorders
Vision- Diplopia
|
3.1%
1/32
|
|
Eye disorders
Vision- Flashing Lights/Floaters
|
3.1%
1/32
|
|
Eye disorders
Watery Eyes
|
12.5%
4/32
|
|
General disorders
Pain- Abdomen
|
40.6%
13/32
|
|
General disorders
Pain- Back
|
40.6%
13/32
|
|
General disorders
Pain- Bone
|
9.4%
3/32
|
|
General disorders
Pain- Chest
|
25.0%
8/32
|
|
General disorders
Pain- External Ear
|
3.1%
1/32
|
|
General disorders
Pain- Extremity, Limb
|
21.9%
7/32
|
|
General disorders
Pain- Finger
|
3.1%
1/32
|
|
General disorders
Pain- Headache
|
31.2%
10/32
|
|
General disorders
Pain- Joint
|
28.1%
9/32
|
|
General disorders
Pain- Muscle
|
21.9%
7/32
|
|
General disorders
Pain- Neck
|
6.2%
2/32
|
|
General disorders
Pain- Throat
|
3.1%
1/32
|
|
General disorders
Pain- General NOS
|
9.4%
3/32
|
|
General disorders
Pain- Shoulder
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm/Wheezing
|
15.6%
5/32
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.6%
13/32
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
56.2%
18/32
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
18.8%
6/32
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
9.4%
3/32
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes/Dysathria
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (Hiccups/Singultus)
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/Pulmonary Infiltrates
|
3.1%
1/32
|
|
Renal and urinary disorders
Cystitis
|
6.2%
2/32
|
|
Renal and urinary disorders
Incontinence, Urinary
|
3.1%
1/32
|
|
Renal and urinary disorders
Renal Failure
|
3.1%
1/32
|
|
Renal and urinary disorders
Urinary Retention
|
6.2%
2/32
|
|
Renal and urinary disorders
Urinary Frequency/Urgency
|
6.2%
2/32
|
|
General disorders
Syndromes- Systemic Inflammatory Response System (SIRS)
|
6.2%
2/32
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place