Trial Outcomes & Findings for Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma (NCT NCT01330966)

Last Updated: 2023-03-10

Results Overview

Disease control at week 16 defined as complete response (CR), Disappearance of all target lesions; plus partial response (PR), At least a 30% decrease in the sum of diameters of the target lesions taking as reference the Baseline sum diameters; plus stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum diameters while on the study; where tumor response is defined by RECIST (Response Evaluation Criteria in Solid Tumors) guidelines version 1.1. Repeat radiologic imaging is performed after every 2 cycles of treatment (approximately every 8 weeks).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

47 participants

Primary outcome timeframe

Assessed at week 16 of study treatment

Results posted on

2023-03-10

Participant Flow

Participant milestones

Participant milestones
Measure	Pazopanib Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity. pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle.
Overall Study STARTED	47
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pazopanib n=47 Participants Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle.
Age, Continuous	58 years n=99 Participants
Sex: Female, Male Female	18 Participants n=99 Participants
Sex: Female, Male Male	29 Participants n=99 Participants
Race/Ethnicity, Customized Caucasian	39 Participants n=99 Participants
Race/Ethnicity, Customized Asian	2 Participants n=99 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=99 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=99 Participants
Region of Enrollment United States	45 participants n=99 Participants
Region of Enrollment United Kingdom	2 participants n=99 Participants

PRIMARY outcome

Timeframe: Assessed at week 16 of study treatment

Population: Tumor responses were evaluable in 42 out of 47 patients; 5 patients discontinued prior to the first tumor assessment.

Outcome measures

Outcome measures
Measure	Pazopanib n=42 Participants Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity. pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle.
Disease Control at Week 16	43 Percentage of CR+PR+SD Interval 28.0 to 58.0

SECONDARY outcome

Timeframe: Cycle 1 day 1 until the subject experiences disease progression

The time origin for PFS will be cycle 1 day 1. Repeat radiologic imaging will be conducted after every 2 cycles of treatment (approximately every 8 weeks). No upper limits of duration of assessment are identified or defined in the protocol.

Outcome measures

Outcome measures
Measure	Pazopanib n=47 Participants Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity. pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle.
Progression Free Survival (PFS)	7.9 months Interval 3.7 to 12.6

SECONDARY outcome

Timeframe: Cycle 1 day 1 until 6 months after end of treatment, is lost to follow-up, or withdraws consent

The time origin for OS will be cycle 1 day 1. Subjects will be followed until 6 months after end of treatment, lost to follow-up, or withdrawal of consent. No upper limits of duration of assessment are identified or defined in the protocol.

Outcome measures

Outcome measures
Measure	Pazopanib n=47 Participants Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity. pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle.
Overall Survival (OS)	17.6 months Interval 11.3 to 35.0

Adverse Events

Pazopanib

Serious events: 19 serious events

Other events: 39 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Pazopanib n=47 participants at risk Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity. pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle.
Infections and infestations Abdominal abscess	2.1% 1/47 • Number of events 1 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Gastrointestinal disorders Abdominal pain	2.1% 1/47 • Number of events 1 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Renal and urinary disorders Acute kidney injury	2.1% 1/47 • Number of events 1 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Investigations Alanine amino transferase increased	2.1% 1/47 • Number of events 2 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Infections and infestations Anorectal infection	2.1% 1/47 • Number of events 1 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Nervous system disorders Central nervous system hemorrhage	2.1% 1/47 • Number of events 1 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.1% 1/47 • Number of events 1 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Vascular disorders Embolism	6.4% 3/47 • Number of events 4 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Injury, poisoning and procedural complications Gastronomy tube site reaction	2.1% 1/47 • Number of events 1 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	2.1% 1/47 • Number of events 1 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Hepatobiliary disorders Hyperbilirubin	2.1% 1/47 • Number of events 2 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Vascular disorders Hypertension	2.1% 1/47 • Number of events 1 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Metabolism and nutrition disorders Hyponatremia	2.1% 1/47 • Number of events 1 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Gastrointestinal disorders Intestinal perforation	2.1% 1/47 • Number of events 1 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Nervous system disorders Paraesthesia	2.1% 1/47 • Number of events 1 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.4% 3/47 • Number of events 3 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	2.1% 1/47 • Number of events 1 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.1% 1/47 • Number of events 1 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	4.3% 2/47 • Number of events 2 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary venous thrombosis	2.1% 1/47 • Number of events 1 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Investigations Troponin increased	2.1% 1/47 • Number of events 1 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.

Other adverse events

Other adverse events
Measure	Pazopanib n=47 participants at risk Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity. pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle.
Blood and lymphatic system disorders Thrombocytopenia	4.3% 2/47 • Number of events 2 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Cardiac disorders Sinus bradycardia	8.5% 4/47 • Number of events 4 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Endocrine disorders Hyperthyroidism	4.3% 2/47 • Number of events 2 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Endocrine disorders Hypothyroidism	12.8% 6/47 • Number of events 6 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Gastrointestinal disorders Abdominal pain upper	4.3% 2/47 • Number of events 2 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Gastrointestinal disorders Constipation	23.4% 11/47 • Number of events 13 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Gastrointestinal disorders Diarrhoea	46.8% 22/47 • Number of events 43 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Gastrointestinal disorders Dyspepsia	10.6% 5/47 • Number of events 5 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Gastrointestinal disorders Nausea	51.1% 24/47 • Number of events 35 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Gastrointestinal disorders Oral dysaesthesia	4.3% 2/47 • Number of events 2 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Gastrointestinal disorders Oral pain	4.3% 2/47 • Number of events 2 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Gastrointestinal disorders Stomatitis	6.4% 3/47 • Number of events 5 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Gastrointestinal disorders Vomiting	21.3% 10/47 • Number of events 14 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
General disorders Fatigue	44.7% 21/47 • Number of events 31 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
General disorders Oedema peripheral	17.0% 8/47 • Number of events 11 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Infections and infestations Bronchitis	4.3% 2/47 • Number of events 2 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Infections and infestations Gingivitis	4.3% 2/47 • Number of events 2 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Infections and infestations Mucosal infection	4.3% 2/47 • Number of events 2 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Infections and infestations Skin infection	4.3% 2/47 • Number of events 2 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Infections and infestations Urinary tract infection	6.4% 3/47 • Number of events 5 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Injury, poisoning and procedural complications Contusion	8.5% 4/47 • Number of events 4 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Investigations Aspatartate amino transferase increased	12.8% 6/47 • Number of events 7 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Investigations Blood bilirubin increased	6.4% 3/47 • Number of events 4 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Investigations Neutrophil count decreased	10.6% 5/47 • Number of events 9 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Investigations Platelet count decreased	10.6% 5/47 • Number of events 10 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Investigations Weight decreased	29.8% 14/47 • Number of events 19 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Investigations White blood cell count decreased	6.4% 3/47 • Number of events 8 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Metabolism and nutrition disorders Decreased appetite	4.3% 2/47 • Number of events 2 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Metabolism and nutrition disorders Hypoabluminanemia	4.3% 2/47 • Number of events 2 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Metabolism and nutrition disorders Hypocalcaemia	4.3% 2/47 • Number of events 3 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Metabolism and nutrition disorders Hypokalaemia	8.5% 4/47 • Number of events 4 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Metabolism and nutrition disorders Vitamin D deficiency	4.3% 2/47 • Number of events 2 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Musculoskeletal and connective tissue disorders Arthralgia	10.6% 5/47 • Number of events 5 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Musculoskeletal and connective tissue disorders Back pain	17.0% 8/47 • Number of events 9 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	8.5% 4/47 • Number of events 4 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	8.5% 4/47 • Number of events 4 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	6.4% 3/47 • Number of events 3 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Musculoskeletal and connective tissue disorders Myalgia	4.3% 2/47 • Number of events 2 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	17.0% 8/47 • Number of events 13 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Nervous system disorders Dizziness	4.3% 2/47 • Number of events 2 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Nervous system disorders Dysgeusia	17.0% 8/47 • Number of events 9 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Nervous system disorders Headache	12.8% 6/47 • Number of events 6 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Nervous system disorders Neuralgia	4.3% 2/47 • Number of events 3 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Renal and urinary disorders Haematuria	4.3% 2/47 • Number of events 2 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Renal and urinary disorders Proteinuria	4.3% 2/47 • Number of events 2 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Respiratory, thoracic and mediastinal disorders Cough	14.9% 7/47 • Number of events 11 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	6.4% 3/47 • Number of events 5 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.3% 2/47 • Number of events 2 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Skin and subcutaneous tissue disorders Hair colour changes	21.3% 10/47 • Number of events 10 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	8.5% 4/47 • Number of events 5 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.3% 2/47 • Number of events 4 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.
Skin and subcutaneous tissue disorders Skin hypopigmentation	10.6% 5/47 • Number of events 6 • For each subject, adverse events were collected beginning at the start of study treatment until 30 days after discontinuation of treatment.

Additional Information

Lindsey Munn

George Clinical

Phone: 901-350-8801

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place