Trial Outcomes & Findings for A Phase II Study of AZD2171 in Breast Cancer Stage IV (10006202) (NCT NCT00244881)

NCT ID: NCT00244881

Last Updated: 2015-12-07

Results Overview

An exact 95% confidence interval (CI) will be calculated for the CEC response rate. With 26 patients, this CI will be no wider than 40% (e.g., if 13 of 26 patients respond, the CI is 30% to 70%).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 26 participants
• Primary outcome timeframe: After 3 weeks of treatment
• Results posted on: 2015-12-07

Participant Flow

Participants were recruited at Dana-Farber/Harvard Cancer Center

Participant milestones

Measure	Treatment (Cediranib Maleate) Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	26
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Treatment (Cediranib Maleate) Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

A Phase II Study of AZD2171 in Breast Cancer Stage IV (10006202)

Baseline characteristics by cohort

Measure	Treatment (Cediranib Maleate) n=26 Participants Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	53.3 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants

PRIMARY outcome

Timeframe: After 3 weeks of treatment

An exact 95% confidence interval (CI) will be calculated for the CEC response rate. With 26 patients, this CI will be no wider than 40% (e.g., if 13 of 26 patients respond, the CI is 30% to 70%).

Outcome measures

Measure	Treatment (Cediranib Maleate) n=26 Participants Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Fraction of Patients With Increased Levels of Circulating Endothelial Cells	30 percentage of participants

PRIMARY outcome

Timeframe: Up to 7 years

RECIST 1.0 Criteria

Outcome measures

Measure	Treatment (Cediranib Maleate) n=26 Participants Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Objective Response Rate (ORR = CR + PR) Classified According to RECIST Criteria	8 percentage of participants Interval 1.0 to 25.0

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	Treatment (Cediranib Maleate) n=26 Participants Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Response/Stable Disease Rate Defined as the Percentage of Patients Demonstrating CR + PR + SD	45 percentage of participants

Adverse Events

Treatment (Cediranib Maleate)

Serious events: 7 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (Cediranib Maleate) n=26 participants at risk Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Gastrointestinal disorders Vomiting	3.8% 1/26 • Number of events 1 • 2 years
Gastrointestinal disorders Esophagitis	3.8% 1/26 • Number of events 1 • 2 years
Respiratory, thoracic and mediastinal disorders Dyspnea	3.8% 1/26 • Number of events 1 • 2 years
Cardiac disorders Left Ventricular Systolic Dysfunction	3.8% 1/26 • Number of events 1 • 2 years
Gastrointestinal disorders Gallbladder Abnormality	3.8% 1/26 • Number of events 1 • 2 years
Cardiac disorders Hypertension	3.8% 1/26 • Number of events 1 • 2 years
Gastrointestinal disorders Diarrhea	3.8% 1/26 • Number of events 1 • 2 years

Other adverse events

Measure	Treatment (Cediranib Maleate) n=26 participants at risk Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Cardiac disorders Hypertension	80.8% 21/26 • Number of events 21 • 2 years
Gastrointestinal disorders Diarrhea	38.5% 10/26 • Number of events 10 • 2 years
General disorders Fatigue	38.5% 10/26 • Number of events 10 • 2 years
Renal and urinary disorders Proteinuria	30.8% 8/26 • Number of events 8 • 2 years
Gastrointestinal disorders Esophagitis/Mucositis	26.9% 7/26 • Number of events 7 • 2 years
Cardiac disorders LFT Abnormalities	26.9% 7/26 • Number of events 7 • 2 years
Endocrine disorders Hypothyroidism	19.2% 5/26 • Number of events 5 • 2 years
Gastrointestinal disorders Nausea	19.2% 5/26 • Number of events 5 • 2 years
Gastrointestinal disorders Vomiting	11.5% 3/26 • Number of events 3 • 2 years
Gastrointestinal disorders Anorexia	11.5% 3/26 • Number of events 3 • 2 years
Gastrointestinal disorders Abdominal Pain	11.5% 3/26 • Number of events 3 • 2 years
Cardiac disorders LV systolic dysfunction	7.7% 2/26 • Number of events 2 • 2 years

Additional Information

Dr Harold Burstein

Dana-Farber Cancer Institute

Phone: 617-632-3800

Email: hburstein@partners.org

Results disclosure agreements

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

Restriction type: LTE60