## Protocol Section
### Identification Module
**NCT ID:** NCT00496379

**Brief Title:** ZK219477 (Sagopilone) in Patients With Breast Cancer and Brain Metastases

**Official Title:** A Phase 2 Study of ZK219477 (ZK-EPO) in Patients With Breast Cancer and Brain Metastases

#### Organization Study ID Info
**ID:** 06-268
#### Organization
**Class:** OTHER
**Full Name:** Dana-Farber Cancer Institute
### Status Module
#### Completion Date
**Date:** 2012-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-03-14

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-03-12

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2009-10

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2013-03-12

**Type:** ESTIMATED

**Results First Submit Date:** 2012-11-30

**Results First Submit QC Date:** 2013-02-07

#### Start Date
**Date:** 2007-07

**Status Verified Date:** 2013-03

#### Study First Post Date
**Date:** 2007-07-04
**Type:** ESTIMATED
**Study First Submit Date:** 2007-07-03
**Study First Submit QC Date:** 2007-07-03
**Why Stopped:** This study has closed to accrual early due to slow accrual.
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Brigham and Women's Hospital

**Class:** INDUSTRY

**Name:** Bayer

**Class:** OTHER

**Name:** Breast Cancer Research Foundation

#### Lead Sponsor

**Class:** OTHER

**Name:** Nancy Lin, MD

#### Responsible Party

**Investigator Affiliation:** Dana-Farber Cancer Institute

**Investigator Full Name:** Nancy Lin, MD

**Investigator Title:** Assistant Professor of Medicine

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this research study is to determine the effects (good and bad) of ZK219477(sagopilone) on participants and their cancer. ZK219477 is a chemotherapy drug that is thought to work by interfering with the ability of cancer cells to grow and divide. It is a part of a group of drugs called "epothilones" which appear to cause shrinkage of cancer in some patients with breast cancer. It is generally difficult for chemotherapy to enter the brain. However, it is believed that ZK219477 crosses into the brain. We are also studying whether an investigational MRI scan procedure may eventually help to predict which patients will benefit from ZK219477.

**Detailed Description:** * Participants will be given ZK219477 intravenously over approximately 30 minutes every three weeks.
* During all treatment cycles a physical exam and questions about the participants general health and specific questions about any problems they may be having will be performed.
* At least every three weeks blood tests will be done to assess the effect of ZK219477 on the body.
* After every 2 cycles of treatment, participants will have additional scans to assess the effect of ZK219477 on their cancer. This will include a CT scan of the abdomen, chest, and pelvis, and an MRI of the brain.
* At the time of the standard MRI, participants will be asked to undergo an additional MRI sequence, which means they will be in the MRI machine for approximately 15-20 more minutes.

### Conditions Module

**Conditions:**

- Breast Cancer

- CNS Disease

**Keywords:**

- metastatic breast cancer

- invasive breast cancer

- brain metastases

- ZK-EPO

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 15

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: ZK219477

**Label:** ZK219477

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ZK219477

**Description:** Given intravenously over approximately 30 minutes once every 3 weeks

**Name:** ZK219477

**Other Names:**

- ZK-EPO

- ZK-Epothilone

- Sagopilone

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Objective Response Rate in the Central Nervous System (CNS)

**Time Frame:** 2 years

#### Secondary Outcomes

**Description:** Adverse events per NCI CTCAE

**Measure:** Number of Subjects With Adverse Events (Any Grade)

**Time Frame:** 2 years

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

**Measure:** Objective Response Rate in Non-Central Nervous System (CNS) Sites

**Time Frame:** 2 years

**Description:** 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

**Measure:** Time to Progression at Any Site.

**Time Frame:** 2 years

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

**Measure:** Clinical Benefit Rate.

**Time Frame:** 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients must have histologically or cytologically invasive breast cancer, with metastatic disease at the time of screening
* Measurable Central Nervous System (CNS) disease, as defined as at least one lesion \> or equal too 10mm in longest dimension
* New or progressive CNS lesions after at least one prior standard CNS-directed therapy for treatment of brain metastases, which could include surgical resection, whole brain radiotherapy (WBRT), and/or stereotactic radiosurgery (SRS). Patients must have received prior WBRT, SRS or both.
* Patient has been evaluated by a radiation oncologist, who feels that the plan to evaluate systemic chemotherapy in place of additional brain radiotherapy is an acceptable option
* No increase in corticosteroid use in the week prior to study entry
* Any number prior lines of chemotherapy for metastatic breast cancer
* 18 years of age of older
* Life expectancy of greater than 12 weeks
* ECOG Performance Status 0-2
* Patients must have normal organ function as outlined in the protocol

Exclusion Criteria:

* Patients who have had chemotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier
* Patients who have had XRT within 3 weeks prior to entering the study or those who have not recovered from adverse events due to XRT
* Patients may not be receiving any other investigational agent
* Patients may not be receiving any cancer-directed therapy
* Prior treatment with investigational chemotherapy for brain metastases
* Prior treatment with epothilone for metastatic breast cancer
* Leptomeningeal carcinomatosis as the only site of CNS involvement.
* Concurrent treatment with an enzyme inducing antiepileptic drug, including phenytoin, carbamezepine, phenobarbital, or oxacarbazepine
* More than 2 seizures over the last four weeks prior to study entry
* Known contraindication to MRI or gadolinium contrast, such as cardiac pacemaker, ocular foreign body, or shrapnel
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or breastfeeding women.

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Boston

**Country:** United States

**Facility:** Dana-Farber Cancer Institute

**State:** Massachusetts

**Zip:** 02115

#### Overall Officials

**Official 1:**

**Affiliation:** Dana-Farber Cancer Institute

**Name:** Nancy Lin, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

- ID: D000009385

- Term: Neoplastic Processes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000016543

- Term: Central Nervous System Neoplasms

- ID: D000009423

- Term: Nervous System Neoplasms

- ID: D000001927

- Term: Brain Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: HIGH

- As Found: Metastases

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: HIGH

- As Found: CNS Disease

- ID: M5209

- Name: Brain Neoplasms

- Relevance: HIGH

- As Found: Brain Metastases

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12330

- Name: Neoplastic Processes

- Relevance: LOW

- As Found: Unknown

- ID: M18937

- Name: Central Nervous System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M12367

- Name: Nervous System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

- ID: D000009362

- Term: Neoplasm Metastasis

- ID: D000001932

- Term: Brain Neoplasms

- ID: D000002493

- Term: Central Nervous System Diseases

### Intervention Browse Module - Ancestors

- ID: D000050257

- Term: Tubulin Modulators

- ID: D000050256

- Term: Antimitotic Agents

- ID: D000050258

- Term: Mitosis Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M24405

- Name: Epothilones

- Relevance: HIGH

- As Found: Breakthrough

- ID: M256183

- Name: Sagopilone

- Relevance: HIGH

- As Found: TUG

- ID: M26197

- Name: Tubulin Modulators

- Relevance: LOW

- As Found: Unknown

- ID: M26196

- Name: Antimitotic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000034261

- Term: Epothilones

- ID: C000530494

- Term: Sagopilone

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Sagopilone

**Description:** Either 16 mg/m2 or 22 mg/m2 IV Q3W

**ID:** EG000

**Other Num Affected:** 15

**Other Num at Risk:** 15

**Serious Number Affected:** 1

**Serious Number At Risk:** 15

**Title:** Sagopilone

**Frequency Threshold:** 5

#### Other Events

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Alopecia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Neurologic-other

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Neuropathy-Sensory

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Blurred/Double Vision

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Eye Pain/ Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Ataxia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Muscle/Joint Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Limb Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Back Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Urinary Incontinence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** 

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Generalized Weakness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Hyperglycemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** 

**Term:** Hypoglycemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** 

**Term:** Hyponatremia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** Hypokalemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** Bicarbonate

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** Liver Function Tests

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** 

**Term:** Hypoalbuminemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** Hypocalcemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** Nausea/Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Anorexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Dyspepsia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Mucositis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Hemoglobin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** 

**Term:** Lymphocytes

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** 

**Term:** Leukocytes

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** 

**Term:** Neutrophils

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** 

**Term:** Platelets

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** 

**Term:** Neuropathy-Motor

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

#### Serious Events

**Term:** Pulmonary Embolus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 15

**Num Events:** 1

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 15

**Units:** Participants

### Group

**ID:** BG000

**Title:** Sagopilone

**Description:** Either 16 mg/m2 or 22 mg/m2 IV Q3W

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 13

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 2

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 12.7

**Value:** 50.3

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 15

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 15

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** nlin@partners.org
**Organization:** Dana-Farber Cancer Institute
**Phone:** 617-632-2335
**Title:** Dr. Nancy Lin
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 40
- **Value:** 13.3
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1
- **Spread:** 
- **Upper Limit:** 4
- **Value:** 1.4
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The study was closed prior to full accrual as detailed in the manuscript
**Reporting Status:** POSTED
**Time Frame:** 2 years
**Title:** Objective Response Rate in the Central Nervous System (CNS)
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Either 16 mg/m2 or 22 mg/m2 IV Q3W
**ID:** OG000
**Title:** Sagopilone
#### Outcome Measure 2
**Description:** Adverse events per NCI CTCAE
**Parameter Type:** NUMBER
**Population Description:** Study was closed prior to full accrual for reasons detailed in published manuscript
**Reporting Status:** POSTED
**Time Frame:** 2 years
**Title:** Number of Subjects With Adverse Events (Any Grade)
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Either 16 mg/m2 or 22 mg/m2 IV Q3W
**ID:** OG000
**Title:** Sagopilone
#### Outcome Measure 3
**Description:** Non-CNS response rate (according to RECIST 1.0) limited to patients with measurable non-CNS disease
**Parameter Type:** NUMBER
**Population Description:** 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
**Reporting Status:** POSTED
**Time Frame:** 2 years
**Title:** Objective Response Rate in Non-Central Nervous System (CNS) Sites
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Either 16 mg/m2 or 22 mg/m2 IV Q3W
**ID:** OG000
**Title:** Sagopilone
#### Outcome Measure 4
**Description:** 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
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** all patients who received at least 1 dose of protocol therapy
**Reporting Status:** POSTED
**Time Frame:** 2 years
**Title:** Time to Progression at Any Site.
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Either 16 mg/m2 or 22 mg/m2 IV Q3W
**ID:** OG000
**Title:** Sagopilone
#### Outcome Measure 5
**Description:** CBR = CR + PR + SD \> 24 weeks in CNS with at least stable non-CNS disease
**Parameter Type:** NUMBER
**Population Description:** all pts who received at least 1 dose of protocol therapy
**Reporting Status:** POSTED
**Time Frame:** 2 years
**Title:** Clinical Benefit Rate.
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Either 16 mg/m2 or 22 mg/m2 IV Q3W
**ID:** OG000
**Title:** Sagopilone
### Participant Flow Module
#### Group
**Description:** Either 16 mg/m2 or 22 mg/m2 IV Q3W
**ID:** FG000
**Title:** Sagopilone
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 15
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 15
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Recruitment Details:** Patients were enrolled at Dana-Farber/Harvard Cancer Center between 8/1/2007-10/29/2009.
**Has Results:** True