Trial Outcomes & Findings for Pazopanib in Treating Patients With Recurrent or Metastatic Breast Cancer (NCT NCT00509587)

NCT ID: NCT00509587

Last Updated: 2018-08-08

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT / MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 21 participants
• Primary outcome timeframe: Up to 3 years
• Results posted on: 2018-08-08

Participant Flow

Participant milestones

Measure	Treatment (Pazopanib Hydrochloride) Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. pazopanib hydrochloride: Given orally pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pazopanib in Treating Patients With Recurrent or Metastatic Breast Cancer

Baseline characteristics by cohort

Measure	Treatment (Pazopanib Hydrochloride) n=21 Participants Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. pazopanib hydrochloride: Given orally pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=93 Participants
Age, Categorical >=65 years	4 Participants n=93 Participants
Age, Continuous	54 years n=93 Participants
Sex: Female, Male Female	21 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment Canada	21 participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT / MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Measure	Treatment (Pazopanib Hydrochloride) n=21 Participants Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. pazopanib hydrochloride: Given orally pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Number of Participants With Partial and Complete Response.	1 participant

SECONDARY outcome

Timeframe: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 3 years

Population: Duration of objective response was not analyzed for 1 patient who achieved PR

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the start of the treatment until the criteria for progression are met, assessed up to 3 years

Outcome measures

Measure	Treatment (Pazopanib Hydrochloride) n=21 Participants Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. pazopanib hydrochloride: Given orally pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Duration of Stable Disease	5.3 months Interval 2.0 to 20.0

SECONDARY outcome

Timeframe: 6 months

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions

Outcome measures

Measure	Treatment (Pazopanib Hydrochloride) n=21 Participants Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. pazopanib hydrochloride: Given orally pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Progression-free Survival	22 percentage of patients Interval 8.0 to 58.0

SECONDARY outcome

Timeframe: Up to 3 years

Computed using the Kaplan-Meier method.

Outcome measures

Measure	Treatment (Pazopanib Hydrochloride) n=21 Participants Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. pazopanib hydrochloride: Given orally pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Overall Survival	12.8 months Interval 7.6 to Upper bound was not reached, as too few events

SECONDARY outcome

Timeframe: Up to 3 years

grade 3- 4 toxicities - transaminitis, hypertension, and neutropenia in three patients each (14% each) and grade 3 gastrointestinal hemorrhage in one patient (5%).

Outcome measures

Measure	Treatment (Pazopanib Hydrochloride) n=21 Participants Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. pazopanib hydrochloride: Given orally pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Adverse Events Graded According to the NCI CTCAE Version 3.0 Grade 3-4 transaminitis	14 percentage of patients
Adverse Events Graded According to the NCI CTCAE Version 3.0 Grade 3-4 Hypertension	14 percentage of patients
Adverse Events Graded According to the NCI CTCAE Version 3.0 Grade 3-4Neutropenia	14 percentage of patients
Adverse Events Graded According to the NCI CTCAE Version 3.0 Grade 3 gastrointestinal hemorrhage	5 percentage of patients

Adverse Events

Treatment (Pazopanib Hydrochloride)

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (Pazopanib Hydrochloride) n=21 participants at risk Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. pazopanib hydrochloride: Given orally pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Gastrointestinal disorders Intra abdominal hemorrhage	4.8% 1/21 • Number of events 1
Gastrointestinal disorders Esophagitis	4.8% 1/21 • Number of events 1

Other adverse events

Measure	Treatment (Pazopanib Hydrochloride) n=21 participants at risk Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. pazopanib hydrochloride: Given orally pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Vascular disorders Hypertension	52.4% 11/21 • Number of events 11
Gastrointestinal disorders Nausea	47.6% 10/21 • Number of events 10
Gastrointestinal disorders Diarrhea	61.9% 13/21 • Number of events 13
Investigations Aspartate aminotransferase increased	14.3% 3/21 • Number of events 3
Investigations Neutrophil Count decreased	14.3% 3/21 • Number of events 3

Additional Information

Dr. Natasha Leighl

Princess Margaret Cancer Centre

Phone: 416-946-2399

Email: natasha.leighl@uhn.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60