Trial Outcomes & Findings for Pazopanib Hydrochloride in Treating Patients With Metastatic Melanoma That Cannot be Removed by Surgery (NCT NCT00861913)

NCT ID: NCT00861913

Last Updated: 2018-10-16

Results Overview

Tumor response rate is defined as the number of eligible patients whose disease status meets the Response Evaluation Criteria In Solid Tumors (RECIST) criteria for compete response (CR) or partial response (PR) divided by the number of evaluable patients. A ninety percent confidence interval for the true response proportion will be calculated assuming that the number of confirmed tumor responses follows a binomial distribution and using the Duffy-Santner approach. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the largest dimension (LD) of target lesions taking as reference the baseline sum LD.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2018-10-16

Participant Flow

From April 2009 to July 2009, 13 participants were registered.

All participants were evaluable for all endpoints and toxicity.

Participant milestones

Participant milestones
Measure	Treatment (Pazopanib Hydrochloride) Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pazopanib Hydrochloride in Treating Patients With Metastatic Melanoma That Cannot be Removed by Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Pazopanib Hydrochloride) n=13 Participants Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Age, Continuous	64 years n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	10 Participants n=93 Participants
Region of Enrollment United States	13 participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome measures
Measure	Treatment (Pazopanib Hydrochloride) n=13 Participants Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Tumor Response Rate	7.7 percentage of patients Interval 0.39 to 31.6

PRIMARY outcome

Timeframe: Up to 5 years

Toxicity is defined as any grade 3 or higher adverse event as assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and at least possibly related to treatment. The maximum grade for each type of toxicity will be recorded for each patient. We report the number of patients experiencing a grade 3 or higher adverse event at least possibly related to treatment.

Outcome measures

Outcome measures
Measure	Treatment (Pazopanib Hydrochloride) n=13 Participants Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Toxicity Grade 3	8 participants
Toxicity Grade 4 or higher	0 participants

SECONDARY outcome

Timeframe: From registration to death due to any cause, assessed up to 5 years

Overall survival time is defined as the time from registration to the time of death due to any cause. Estimated using the method of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Treatment (Pazopanib Hydrochloride) n=13 Participants Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Survival	13.6 months Interval 6.0 to 18.6

SECONDARY outcome

Timeframe: From registration to documentation of disease progression, assessed up to 5 years

Progression free survival is defined as the time from registration to the time of progression or death, whichever occurs first. Estimated using the method of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Treatment (Pazopanib Hydrochloride) n=13 Participants Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Progression Free Survival	3.9 months Interval 1.8 to 4.0

SECONDARY outcome

Timeframe: From time of documented response to the date progression is documented, assessed up to 5 years.

Population: There was one response and therefore median duration of response was not analyzed.

The date at which the objective status is first noted to be either a Complete Response (CR) or Partial Response (PR) to the date progression is documented, assessed up to 5 years.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Pazopanib Hydrochloride)

Serious events: 5 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Pazopanib Hydrochloride) n=13 participants at risk Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Hemoglobin decreased	7.7% 1/13 • Number of events 2
Endocrine disorders Hypothyroidism	7.7% 1/13 • Number of events 1
Infections and infestations Pneumonia	7.7% 1/13 • Number of events 1
Investigations Leukocyte count decreased	15.4% 2/13 • Number of events 3
Investigations Neutrophil count decreased	7.7% 1/13 • Number of events 2
Investigations Platelet count decreased	15.4% 2/13 • Number of events 3
Musculoskeletal and connective tissue disorders Muscle weakness	7.7% 1/13 • Number of events 1
Nervous system disorders Taste alteration	7.7% 1/13 • Number of events 1
Respiratory, thoracic and mediastinal disorders Dyspnea	7.7% 1/13 • Number of events 1

Other adverse events

Other adverse events
Measure	Treatment (Pazopanib Hydrochloride) n=13 participants at risk Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Hemoglobin decreased	53.8% 7/13 • Number of events 15
Endocrine disorders Hypothyroidism	23.1% 3/13 • Number of events 5
Eye disorders Eye disorder	7.7% 1/13 • Number of events 1
Eye disorders Vision blurred	15.4% 2/13 • Number of events 3
Gastrointestinal disorders Abdominal pain	7.7% 1/13 • Number of events 4
Gastrointestinal disorders Constipation	7.7% 1/13 • Number of events 3
Gastrointestinal disorders Diarrhea	61.5% 8/13 • Number of events 37
Gastrointestinal disorders Dyspepsia	7.7% 1/13 • Number of events 1
Gastrointestinal disorders Hemorrhoids	7.7% 1/13 • Number of events 1
Gastrointestinal disorders Intra-abdominal hemorrhage	7.7% 1/13 • Number of events 1
Gastrointestinal disorders Lower gastrointestinal hemorrhage	7.7% 1/13 • Number of events 1
Gastrointestinal disorders Mucositis oral	23.1% 3/13 • Number of events 3
Gastrointestinal disorders Nausea	61.5% 8/13 • Number of events 16
Gastrointestinal disorders Oral hemorrhage	7.7% 1/13 • Number of events 1
Gastrointestinal disorders Oral pain	7.7% 1/13 • Number of events 1
Gastrointestinal disorders Upper gastrointestinal hemorrhage	7.7% 1/13 • Number of events 2
Gastrointestinal disorders Vomiting	30.8% 4/13 • Number of events 6
General disorders Edema limbs	7.7% 1/13 • Number of events 1
General disorders Fatigue	100.0% 13/13 • Number of events 48
General disorders Fever	15.4% 2/13 • Number of events 2
General disorders Pain	7.7% 1/13 • Number of events 1
Infections and infestations Gingival infection	7.7% 1/13 • Number of events 1
Infections and infestations Skin infection	15.4% 2/13 • Number of events 3
Investigations Amylase increased	7.7% 1/13 • Number of events 2
Investigations Bilirubin increased	7.7% 1/13 • Number of events 2
Investigations Leukocyte count decreased	38.5% 5/13 • Number of events 20
Investigations Neutrophil count decreased	30.8% 4/13 • Number of events 11
Investigations Platelet count decreased	30.8% 4/13 • Number of events 23
Investigations Weight loss	7.7% 1/13 • Number of events 1
Metabolism and nutrition disorders Anorexia	61.5% 8/13 • Number of events 11
Musculoskeletal and connective tissue disorders Back pain	7.7% 1/13 • Number of events 1
Musculoskeletal and connective tissue disorders Chest wall pain	15.4% 2/13 • Number of events 2
Musculoskeletal and connective tissue disorders Joint pain	7.7% 1/13 • Number of events 2
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	7.7% 1/13 • Number of events 1
Musculoskeletal and connective tissue disorders Myalgia	7.7% 1/13 • Number of events 1
Nervous system disorders Dizziness	7.7% 1/13 • Number of events 1
Nervous system disorders Taste alteration	38.5% 5/13 • Number of events 13
Psychiatric disorders Anxiety	7.7% 1/13 • Number of events 3
Psychiatric disorders Depression	7.7% 1/13 • Number of events 1
Renal and urinary disorders Cystitis	7.7% 1/13 • Number of events 1
Renal and urinary disorders Protein urine positive	15.4% 2/13 • Number of events 16
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	7.7% 1/13 • Number of events 1
Respiratory, thoracic and mediastinal disorders Cough	15.4% 2/13 • Number of events 2
Respiratory, thoracic and mediastinal disorders Dyspnea	30.8% 4/13 • Number of events 4
Skin and subcutaneous tissue disorders Dry skin	7.7% 1/13 • Number of events 1
Skin and subcutaneous tissue disorders Rash desquamating	7.7% 1/13 • Number of events 4
Skin and subcutaneous tissue disorders Skin hypopigmentation	23.1% 3/13 • Number of events 18
Vascular disorders Hemorrhage	7.7% 1/13 • Number of events 1
Vascular disorders Hypertension	30.8% 4/13 • Number of events 8

Additional Information

Amy M. Weise, D. O.

Karmanos Cancer Institute, Wayne State University

Phone: 313-576-8952

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60