Trial Outcomes & Findings for Pazopanib In Patients With Relapsed Or Refractory Soft Tissue Sarcoma (NCT NCT00297258)
NCT ID: NCT00297258
Last Updated: 2016-02-03
Results Overview
Progression free survival at week 12 is the number of participants who had a complete response (CR, all detectable tumor had disappeared) or a partial response (PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum) or stable disease (SD, no change) 12 weeks from start of therapy, per response evaluation criteria in solid tumors (RECIST v1.0). Clinical progression is progression of disease without documented radiological evidence. Progressive disease (PD), a \>=20% increase in target lesions.
COMPLETED
PHASE2
148 participants
Week 12
2016-02-03
Participant Flow
Participant milestones
| Measure |
Pazopanib 800 mg
Pazopanib 800 milligram (mg) (tablets) administered orally once a day
|
|---|---|
|
Overall Study
STARTED
|
142
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
142
|
Reasons for withdrawal
| Measure |
Pazopanib 800 mg
Pazopanib 800 milligram (mg) (tablets) administered orally once a day
|
|---|---|
|
Overall Study
Disease Progression, Relapse, Death
|
120
|
|
Overall Study
Toxicity (or Toxic Death)
|
10
|
|
Overall Study
Patient Refusal: Not Related to Toxicity
|
2
|
|
Overall Study
Intercurrent Illness
|
3
|
|
Overall Study
Intercurrent Death
|
2
|
|
Overall Study
Deteriorization of General Condition
|
1
|
|
Overall Study
Radiotherapy to Destroy Last Lesion
|
1
|
|
Overall Study
Surgery Performed on Target Lesion
|
1
|
|
Overall Study
Switch to Commercial Treatment
|
1
|
|
Overall Study
Interruption: Cold/Flu-like Symptoms
|
1
|
Baseline Characteristics
Pazopanib In Patients With Relapsed Or Refractory Soft Tissue Sarcoma
Baseline characteristics by cohort
| Measure |
Pazopanib 800 mg
n=142 Participants
Pazopanib 800 milligram (mg) (tablets) administered orally once a day
|
|---|---|
|
Age, Continuous
|
51.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Intent-to-Treat (ITT) Population: All eligible participants entered into the study and who had taken \>=1 dose of investigational product. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.
Progression free survival at week 12 is the number of participants who had a complete response (CR, all detectable tumor had disappeared) or a partial response (PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum) or stable disease (SD, no change) 12 weeks from start of therapy, per response evaluation criteria in solid tumors (RECIST v1.0). Clinical progression is progression of disease without documented radiological evidence. Progressive disease (PD), a \>=20% increase in target lesions.
Outcome measures
| Measure |
Pazopanib 800 mg - Adipocytic Tumors
n=19 Participants
Pazopanib 800 mg (tablets) administered orally once a day
|
Pazopanib 800 mg - Leiomyosarcoma
n=41 Participants
Pazopanib 800 mg (tablets) administered orally once a day
|
Pazopanib 800 mg - Synovial Sarcoma
n=37 Participants
Pazopanib 800 mg (tablets) administered orally once a day
|
Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)
n=41 Participants
Pazopanib 800 mg (tablets) administered orally once a day
|
|---|---|---|---|---|
|
Progression Free Survival at Week 12
Complete Response
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Progression Free Survival at Week 12
Partial Response
|
0 participants
|
1 participants
|
4 participants
|
1 participants
|
|
Progression Free Survival at Week 12
Stable Disease
|
5 participants
|
16 participants
|
14 participants
|
16 participants
|
|
Progression Free Survival at Week 12
Progressive Disease
|
13 participants
|
19 participants
|
15 participants
|
21 participants
|
|
Progression Free Survival at Week 12
Unknown
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
|
Progression Free Survival at Week 12
Missing
|
1 participants
|
3 participants
|
4 participants
|
2 participants
|
|
Progression Free Survival at Week 12
CR+PR+SD
|
5 participants
|
17 participants
|
18 participants
|
17 participants
|
SECONDARY outcome
Timeframe: Start of therapy until death (up to approximately 5 years)Population: ITT Population. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.
Overall survival is defined as the time from start of therapy until death. Participants who were still alive at the time of analysis were censored.
Outcome measures
| Measure |
Pazopanib 800 mg - Adipocytic Tumors
n=19 Participants
Pazopanib 800 mg (tablets) administered orally once a day
|
Pazopanib 800 mg - Leiomyosarcoma
n=41 Participants
Pazopanib 800 mg (tablets) administered orally once a day
|
Pazopanib 800 mg - Synovial Sarcoma
n=37 Participants
Pazopanib 800 mg (tablets) administered orally once a day
|
Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)
n=41 Participants
Pazopanib 800 mg (tablets) administered orally once a day
|
|---|---|---|---|---|
|
Overall Survival
|
28.1 years
Interval 18.3 to 84.0
|
50.9 years
Interval 46.1 to 76.4
|
44.6 years
Interval 33.0 to 57.6
|
42.6 years
Interval 33.1 to 49.3
|
SECONDARY outcome
Timeframe: Start of therapy until progression (up to approximately 5 years)Population: Intent-to-Treat (ITT) Population: all eligible participants who had started therapy. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.
Progression free survival is defined as the interval between the start of treatment and the earliest date of disease progression or death due to any cause. Assessments of progression were made by the investigator.
Outcome measures
| Measure |
Pazopanib 800 mg - Adipocytic Tumors
n=19 Participants
Pazopanib 800 mg (tablets) administered orally once a day
|
Pazopanib 800 mg - Leiomyosarcoma
n=41 Participants
Pazopanib 800 mg (tablets) administered orally once a day
|
Pazopanib 800 mg - Synovial Sarcoma
n=37 Participants
Pazopanib 800 mg (tablets) administered orally once a day
|
Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)
n=41 Participants
Pazopanib 800 mg (tablets) administered orally once a day
|
|---|---|---|---|---|
|
Progression Free Survival
|
11.1 years
Interval 7.1 to 11.9
|
17.2 years
Interval 12.0 to 24.1
|
23.4 years
Interval 11.7 to 29.3
|
14.0 years
Interval 12.0 to 36.3
|
SECONDARY outcome
Timeframe: Baseline until either response or progression (up to approximately 5 years)Population: Intent-to-Treat (ITT) Population: all eligible participants who had started therapy. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.
Overall response is the number of participants who had a best outcome of a complete response (CR, all detectable tumor had disappeared) or a partial response (PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum) per response evaluation criteria in solid tumors (RECIST v1.0) at some point during the study. Progressive disease (PD), a \>=20% increase in target lesions. Clinical progression is progression of disease without documented radiological evidence.
Outcome measures
| Measure |
Pazopanib 800 mg - Adipocytic Tumors
n=19 Participants
Pazopanib 800 mg (tablets) administered orally once a day
|
Pazopanib 800 mg - Leiomyosarcoma
n=41 Participants
Pazopanib 800 mg (tablets) administered orally once a day
|
Pazopanib 800 mg - Synovial Sarcoma
n=37 Participants
Pazopanib 800 mg (tablets) administered orally once a day
|
Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)
n=41 Participants
Pazopanib 800 mg (tablets) administered orally once a day
|
|---|---|---|---|---|
|
Overall Response
Progressive Disease
|
13 participants
|
19 participants
|
13 participants
|
21 participants
|
|
Overall Response
Missing
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Overall Response
Complete Response
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Overall Response
Partial Response
|
0 participants
|
1 participants
|
4 participants
|
3 participants
|
|
Overall Response
Stable Disease
|
5 participants
|
17 participants
|
14 participants
|
14 participants
|
|
Overall Response
Unknown
|
1 participants
|
4 participants
|
6 participants
|
3 participants
|
Adverse Events
Pazopanib 800 mg
Serious adverse events
| Measure |
Pazopanib 800 mg
n=142 participants at risk
Pazopanib 800 milligram (mg) (tablets) administered orally once a day
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
3/142 • Entire Study (average of 8.24 years).
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
3/142 • Entire Study (average of 8.24 years).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Gastrointestinal disorders
Gingivitis
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Gastrointestinal disorders
Ileal perforation
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Gastrointestinal disorders
Peritonitis
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
General disorders
General physical health deterioration
|
1.4%
2/142 • Entire Study (average of 8.24 years).
|
|
General disorders
Chest pain
|
1.4%
2/142 • Entire Study (average of 8.24 years).
|
|
General disorders
Fatigue
|
1.4%
2/142 • Entire Study (average of 8.24 years).
|
|
General disorders
Pyrexia
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
General disorders
Ill-defined disorder
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
General disorders
Oedema
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.5%
5/142 • Entire Study (average of 8.24 years).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Vascular disorders
Embolism
|
3.5%
5/142 • Entire Study (average of 8.24 years).
|
|
Vascular disorders
Hypertension
|
2.1%
3/142 • Entire Study (average of 8.24 years).
|
|
Infections and infestations
Pnuemonia
|
1.4%
2/142 • Entire Study (average of 8.24 years).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Infections and infestations
Sepsis
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
2/142 • Entire Study (average of 8.24 years).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Injury, poisoning and procedural complications
Fall
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Injury, poisoning and procedural complications
Laceration
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Nervous system disorders
Somnolence
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Nervous system disorders
Syncope
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Cardiac disorders
Coronary artery disease
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Eye disorders
Vision blurred
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
|
Psychiatric disorders
Depression
|
0.70%
1/142 • Entire Study (average of 8.24 years).
|
Other adverse events
| Measure |
Pazopanib 800 mg
n=142 participants at risk
Pazopanib 800 milligram (mg) (tablets) administered orally once a day
|
|---|---|
|
General disorders
Fatigue
|
59.2%
84/142 • Entire Study (average of 8.24 years).
|
|
Gastrointestinal disorders
Diarrhoea
|
43.7%
62/142 • Entire Study (average of 8.24 years).
|
|
Gastrointestinal disorders
Nausea
|
42.3%
60/142 • Entire Study (average of 8.24 years).
|
|
Vascular disorders
Hypertension
|
40.1%
57/142 • Entire Study (average of 8.24 years).
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
37.3%
53/142 • Entire Study (average of 8.24 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
35.9%
51/142 • Entire Study (average of 8.24 years).
|
|
Gastrointestinal disorders
Vomiting
|
33.8%
48/142 • Entire Study (average of 8.24 years).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
31.7%
45/142 • Entire Study (average of 8.24 years).
|
|
Metabolism and nutrition disorders
Weight decreased
|
31.7%
45/142 • Entire Study (average of 8.24 years).
|
|
Gastrointestinal disorders
Constipation
|
23.2%
33/142 • Entire Study (average of 8.24 years).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.2%
33/142 • Entire Study (average of 8.24 years).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
22.5%
32/142 • Entire Study (average of 8.24 years).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
21.8%
31/142 • Entire Study (average of 8.24 years).
|
|
Nervous system disorders
Headache
|
21.1%
30/142 • Entire Study (average of 8.24 years).
|
|
Gastrointestinal disorders
Abdominal pain
|
19.0%
27/142 • Entire Study (average of 8.24 years).
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
16.2%
23/142 • Entire Study (average of 8.24 years).
|
|
General disorders
Oedema
|
14.8%
21/142 • Entire Study (average of 8.24 years).
|
|
Gastrointestinal disorders
Stomatitis
|
12.7%
18/142 • Entire Study (average of 8.24 years).
|
|
General disorders
Chest pain
|
12.0%
17/142 • Entire Study (average of 8.24 years).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.9%
14/142 • Entire Study (average of 8.24 years).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.6%
15/142 • Entire Study (average of 8.24 years).
|
|
General disorders
Pyrexia
|
12.0%
17/142 • Entire Study (average of 8.24 years).
|
|
Nervous system disorders
Dysgeusia
|
9.2%
13/142 • Entire Study (average of 8.24 years).
|
|
Gastrointestinal disorders
Abdominal distension
|
8.5%
12/142 • Entire Study (average of 8.24 years).
|
|
Psychiatric disorders
Anxiety
|
9.2%
13/142 • Entire Study (average of 8.24 years).
|
|
Nervous system disorders
Dizziness
|
8.5%
12/142 • Entire Study (average of 8.24 years).
|
|
Psychiatric disorders
Insomnia
|
7.7%
11/142 • Entire Study (average of 8.24 years).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.0%
10/142 • Entire Study (average of 8.24 years).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.3%
9/142 • Entire Study (average of 8.24 years).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.3%
9/142 • Entire Study (average of 8.24 years).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
8/142 • Entire Study (average of 8.24 years).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.3%
9/142 • Entire Study (average of 8.24 years).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
8/142 • Entire Study (average of 8.24 years).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.3%
9/142 • Entire Study (average of 8.24 years).
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER