Trial Outcomes & Findings for ZK219477 (Sagopilone) in Patients With Breast Cancer and Brain Metastases (NCT NCT00496379)

NCT ID: NCT00496379

Last Updated: 2013-03-14

Results Overview

Objective response rate is defined as at least a 50 percent reduction in the Central Nervous system target lesion volume compared to the lesion volume at baseline.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2013-03-14

Participant Flow

Patients were enrolled at Dana-Farber/Harvard Cancer Center between 8/1/2007-10/29/2009.

Participant milestones

Measure	Sagopilone Either 16 mg/m2 or 22 mg/m2 IV Q3W
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ZK219477 (Sagopilone) in Patients With Breast Cancer and Brain Metastases

Baseline characteristics by cohort

Measure	Sagopilone n=15 Participants Either 16 mg/m2 or 22 mg/m2 IV Q3W
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age Continuous	50.3 years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: The study was closed prior to full accrual as detailed in the manuscript

Objective response rate is defined as at least a 50 percent reduction in the Central Nervous system target lesion volume compared to the lesion volume at baseline.

Outcome measures

Measure	Sagopilone n=15 Participants Either 16 mg/m2 or 22 mg/m2 IV Q3W
Objective Response Rate in the Central Nervous System (CNS)	13.3 percentage of participants Interval 2.0 to 40.0

SECONDARY outcome

Timeframe: 2 years

Population: Study was closed prior to full accrual for reasons detailed in published manuscript

Adverse events per NCI CTCAE

Outcome measures

Measure	Sagopilone n=15 Participants Either 16 mg/m2 or 22 mg/m2 IV Q3W
Number of Subjects With Adverse Events (Any Grade)	15 participants

SECONDARY outcome

Timeframe: 2 years

Population: only included the 8 pts with measurable non-CNS disease at baseline. The 7 pts with non-measurable non-CNS disease at baseline were not included in the denominator for this endpoint

Non-CNS response rate (according to RECIST 1.0) limited to patients with measurable non-CNS disease

Outcome measures

Measure	Sagopilone n=8 Participants Either 16 mg/m2 or 22 mg/m2 IV Q3W
Objective Response Rate in Non-Central Nervous System (CNS) Sites	0 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Population: all patients who received at least 1 dose of protocol therapy

Time from date of registration until the date of the first documentation of progression or date of death (from any cause),whichever came first, up to 2 years from registration. Progression is defined as either progression in the Central Nervous system (CNS) according to volumetric measurement (Freedman et al. 2011) and /or progression in non-Central Nervous System lesion Measured by RECIST 1.0

Outcome measures

Measure	Sagopilone n=15 Participants Either 16 mg/m2 or 22 mg/m2 IV Q3W
Time to Progression at Any Site.	1.4 months Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: 2 years

Population: all pts who received at least 1 dose of protocol therapy

CBR = CR + PR + SD > 24 weeks in CNS with at least stable non-CNS disease

Outcome measures

Measure	Sagopilone n=15 Participants Either 16 mg/m2 or 22 mg/m2 IV Q3W
Clinical Benefit Rate.	13 percentage of participants

Adverse Events

Sagopilone

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sagopilone n=15 participants at risk Either 16 mg/m2 or 22 mg/m2 IV Q3W
Respiratory, thoracic and mediastinal disorders Pulmonary Embolus	6.7% 1/15 • Number of events 1

Other adverse events

Measure	Sagopilone n=15 participants at risk Either 16 mg/m2 or 22 mg/m2 IV Q3W
General disorders Fatigue	73.3% 11/15 • Number of events 11
Skin and subcutaneous tissue disorders Alopecia	6.7% 1/15 • Number of events 1
Nervous system disorders Neurologic-other	6.7% 1/15 • Number of events 1
Nervous system disorders Neuropathy-Sensory	46.7% 7/15 • Number of events 7
Nervous system disorders Dizziness	13.3% 2/15 • Number of events 2
Nervous system disorders Blurred/Double Vision	20.0% 3/15 • Number of events 3
Nervous system disorders Eye Pain/ Headache	6.7% 1/15 • Number of events 1
Nervous system disorders Ataxia	13.3% 2/15 • Number of events 2
Musculoskeletal and connective tissue disorders Muscle/Joint Pain	26.7% 4/15 • Number of events 4
Musculoskeletal and connective tissue disorders Limb Pain	6.7% 1/15 • Number of events 1
Musculoskeletal and connective tissue disorders Back Pain	6.7% 1/15 • Number of events 1
Renal and urinary disorders Urinary Incontinence	6.7% 1/15 • Number of events 1
General disorders Insomnia	6.7% 1/15 • Number of events 1
Musculoskeletal and connective tissue disorders Generalized Weakness	6.7% 1/15 • Number of events 1
Endocrine disorders Hyperglycemia	26.7% 4/15 • Number of events 4
Endocrine disorders Hypoglycemia	6.7% 1/15 • Number of events 1
Metabolism and nutrition disorders Hyponatremia	6.7% 1/15 • Number of events 1
Metabolism and nutrition disorders Hypokalemia	6.7% 1/15 • Number of events 1
Metabolism and nutrition disorders Bicarbonate	6.7% 1/15 • Number of events 1
Hepatobiliary disorders Liver Function Tests	40.0% 6/15 • Number of events 6
Metabolism and nutrition disorders Hypoalbuminemia	20.0% 3/15 • Number of events 3
Metabolism and nutrition disorders Hypocalcemia	20.0% 3/15 • Number of events 3
Gastrointestinal disorders Nausea/Vomiting	40.0% 6/15 • Number of events 6
Gastrointestinal disorders Anorexia	13.3% 2/15 • Number of events 2
Gastrointestinal disorders Dyspepsia	6.7% 1/15 • Number of events 1
Gastrointestinal disorders Constipation	13.3% 2/15 • Number of events 2
Infections and infestations Mucositis	6.7% 1/15 • Number of events 1
Blood and lymphatic system disorders Hemoglobin	33.3% 5/15 • Number of events 5
Blood and lymphatic system disorders Lymphocytes	33.3% 5/15 • Number of events 5
Blood and lymphatic system disorders Leukocytes	20.0% 3/15 • Number of events 3
Blood and lymphatic system disorders Neutrophils	20.0% 3/15 • Number of events 3
Blood and lymphatic system disorders Platelets	6.7% 1/15 • Number of events 1
Nervous system disorders Neuropathy-Motor	6.7% 1/15 • Number of events 1

Additional Information

Dr. Nancy Lin

Dana-Farber Cancer Institute

Phone: 617-632-2335

Email: nlin@partners.org

Results disclosure agreements

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