NCT00217620

Brief Summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with advanced soft tissue sarcomas.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_2

Geographic Reach
1 country

184 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
2 months until next milestone

Results Posted

Study results publicly available

November 1, 2012

Completed
Last Updated

May 15, 2014

Status Verified

January 1, 2013

Enrollment Period

2.1 years

First QC Date

September 20, 2005

Results QC Date

October 3, 2012

Last Update Submit

May 5, 2014

Conditions

Keywords

adult angiosarcomaadult leiomyosarcomaadult liposarcomaadult malignant hemangiopericytomarecurrent adult soft tissue sarcomastage III adult soft tissue sarcomastage IV adult soft tissue sarcoma

Outcome Measures

Primary Outcomes (1)

  • Objective Response (Confirmed, Complete and Partial)

    Partial response (PR) is greater than or equal to 30% decrease under baseline of sum of longest diameters of all target measurable lesions; No unequivocal progression of non-measurable disease; No new lesions. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration. Stable disease does not qualify for CR, PR, Progression or Symptomatic Deterioration. Progressive disease is any one or more of the following: 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed; unequivocal progression of non-measurable disease; appearance of any new lesion/site; death due to disease without prior documentation of progression and without symptomatic deterioration. Assessment inadequate is progression or symptomatic deterioration has not been documented, and one or more target measurable lesions have not been assessed or inconsistent assessment methods were used.

    Assessment performed every eight weeks until progression.

Secondary Outcomes (2)

  • Four-month Progression-free Survival Rate

    0 - 4 months

  • Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug

    Patients were assessed for adverse events two weeks after starting protocol treatment and then after every cycle of treatment (1 cycle = 28 days) for the duration of protocol treatment.

Study Arms (1)

sorafenib

EXPERIMENTAL

sorafenib

Drug: sorafenib

Interventions

800 mg per day, daily until progression

Also known as: BAY 43-9006
sorafenib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed soft tissue sarcoma of 1 of the following histologies: * Angiosarcoma, cutaneous or visceral * Malignant hemangiosarcoma * Malignant hemangiopericytoma * Grade 3-4 leiomyosarcoma * Grade 3-4 liposarcoma * Must have evidence of unresectable residual disease, metastatic disease, or recurrent disease by radiography * Measurable disease by x-ray, scans, or physical examination * Archived paraffin-embedded tumor sections available * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver metastases) * Bilirubin normal (≤ 2.5 times ULN if due to liver metastases) * PT, PTT, and INR normal Renal * Creatinine normal OR * Creatinine clearance ≥ 60 mL/min Cardiovascular * No history of thromboembolic disease * No uncontrolled hypertension Other * Not pregnant or nursing * Fertile patients must use effective contraception * Able to swallow oral medication * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * At least 28 days since prior chemotherapy (42 days for carmustine or mitomycin) and recovered * Prior adjuvant chemotherapy allowed * No more than 1 prior chemotherapy regimen for metastatic disease Endocrine therapy * Not specified Radiotherapy * At least 28 days since prior radiotherapy and recovered * Must have evidence of disease progression within, or measurable disease outside of, the radiation field after completion of radiotherapy Surgery * At least 28 days since prior major surgery and recovered Other * No prior sorafenib * No prior inhibitor of VEGFR or MAPK pathway * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent investigational agents * No concurrent therapeutic anticoagulation * No concurrent administration of any of the following medications: * Rifampin * Hypericum perforatum (St. John's wort) * Cytochrome P450 enzyme-inducing antiepileptic drugs, including any of the following: * Phenytoin * Carbamazepine * Phenobarbital

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (184)

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724-5024, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Alta Bates Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

Peninsula Medical Center

Burlingame, California, 94010, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Marin Cancer Institute at Marin General Hospital

Greenbrae, California, 94904, United States

Location

Sutter Health - Western Division Cancer Research Group

Greenbrae, California, 94904, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Kaiser Permanente Medical Office -Vandever Medical Office

San Diego, California, 92120, United States

Location

California Pacific Medical Center - California Campus

San Francisco, California, 94118, United States

Location

Sutter Solano Medical Center

Vallejo, California, 94589, United States

Location

Front Range Cancer Specialists

Fort Collins, Colorado, 80524, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

M.D. Anderson Cancer Center Orlando

Orlando, Florida, 32806, United States

Location

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, 31403-3089, United States

Location

Rush-Copley Cancer Care Center

Aurora, Illinois, 60507, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, 60435, United States

Location

Trinity Medical Center - East

Moline, Illinois, 61265, United States

Location

Unknown Facility

Moline, Illinois, 61265, United States

Location

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, 62781-0001, United States

Location

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, 46107, United States

Location

Saint Anthony Memorial Health Centers

Michigan City, Indiana, 46360, United States

Location

Reid Hospital & Health Care Services, Incorporated

Richmond, Indiana, 47374, United States

Location

Unknown Facility

Bettendorf, Iowa, 52722, United States

Location

Mercy Capitol Hospital

Des Moines, Iowa, 50307, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309, United States

Location

John Stoddard Cancer Center at Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates at John Stoddard Cancer Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates at Mercy Cancer Center

Des Moines, Iowa, 50314, United States

Location

Mercy Cancer Center at Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

Location

John Stoddard Cancer Center at Iowa Lutheran Hospital

Des Moines, Iowa, 50316-2301, United States

Location

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, 51101, United States

Location

Mercy Medical Center - Sioux City

Sioux City, Iowa, 51104, United States

Location

St. Luke's Regional Medical Center

Sioux City, Iowa, 51104, United States

Location

Medical Oncology and Hematology Associates - West Des Moines

West Des Moines, Iowa, 50266, United States

Location

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, 67042, United States

Location

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas, PA - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas, PA - Salina

Salina, Kansas, 67042, United States

Location

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health, PA - North Review

Wichita, Kansas, 67203, United States

Location

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, 67156, United States

Location

Battle Creek Health System Cancer Care Center

Battle Creek, Michigan, 49017, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Green Bay Oncology, Limited - Escanaba

Escanaba, Michigan, 49431, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

Lacks Cancer Center at Saint Mary's Health Care

Grand Rapids, Michigan, 49503, United States

Location

Spectrum Health Hospital - Butterworth Campus

Grand Rapids, Michigan, 49503, United States

Location

Metro Health Hospital

Grand Rapids, Michigan, 49506, United States

Location

Holland Community Hospital

Holland, Michigan, 49423, United States

Location

Green Bay Oncology, Limited - Iron Mountain

Iron Mountain, Michigan, 49801, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007-3731, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

Borgess Medical Center

Kalamazooaa, Michigan, 49001, United States

Location

Hackley Hospital

Muskegon, Michigan, 49442, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Minnesota Oncology Hematology, PA at Maplewood Cancer Center

Maplewood, Minnesota, 55109, United States

Location

Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Hubert H. Humphrey Cancer Center at North Memorial Medical Center

Robbinsdale, Minnesota, 55422-2900, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Park Nicollet Health Services

Saint Louis Park, Minnesota, 55416, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

Minnesota Oncology Hematology, PA - Woodbury

Woodbury, Minnesota, 55125, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65802, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, 59101, United States

Location

Northern Rockies Radiation Oncology Center

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare

Billings, Montana, 59101, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59107-5100, United States

Location

Deaconess Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

Bozeman Deaconess Cancer Center

Bozeman, Montana, 59715, United States

Location

St. James Community Hospital

Butte, Montana, 59701, United States

Location

Big Sky Oncology

Great Falls, Montana, 59405, United States

Location

Great Falls Clinic

Great Falls, Montana, 59405, United States

Location

Sletten Regional Cancer Institute at Benefis Healthcare

Great Falls, Montana, 59405, United States

Location

St. Peter's Hospital

Helena, Montana, 59601, United States

Location

Glacier Oncology, PLLC

Kalispell, Montana, 59901, United States

Location

Kalispell Medical Oncology

Kalispell, Montana, 59901, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Community Medical Center

Missoula, Montana, 59801, United States

Location

Guardian Oncology and Center for Wellness

Missoula, Montana, 59804, United States

Location

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, 59807-7877, United States

Location

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, 59807, United States

Location

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

Marlton, New Jersey, 08053, United States

Location

Fox Chase Virtua Health Cancer Program at Virtua West Jersey

Voorhees Township, New Jersey, 08043, United States

Location

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, 87131-5636, United States

Location

Adirondack Cancer Care - Glens Falls

Glens Falls, New York, 12801, United States

Location

Charles R. Wood Cancer Center at Glens Falls Hospital

Glens Falls, New York, 12801, United States

Location

Tucker Center for Cancer Care at Orange Regional Medical Center

Middletown, New York, 10940-4199, United States

Location

CCOP - Hematology-Oncology Associates of Central New York

Syracuse, New York, 13057, United States

Location

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, 28233-3549, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Wayne Radiation Oncology

Goldsboro, North Carolina, 27534, United States

Location

Rutherford Hospital

Rutherfordton, North Carolina, 28139, United States

Location

Wilson Medical Center

Wilson, North Carolina, 27893-3428, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Grandview Hospital

Dayton, Ohio, 45405, United States

Location

Good Samaritan Hospital

Dayton, Ohio, 45406, United States

Location

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Samaritan North Cancer Care Center

Dayton, Ohio, 45415, United States

Location

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, 45428, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

Blanchard Valley Medical Associates

Findlay, Ohio, 45840, United States

Location

Community Oncology Group at Cleveland Clinic Cancer Center

Independence, Ohio, 44131, United States

Location

Charles F. Kettering Memorial Hospital

Kettering, Ohio, 45429, United States

Location

St. Rita's Medical Center

Lima, Ohio, 45801, United States

Location

Middletown Regional Hospital

Middletown, Ohio, 45044, United States

Location

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, 45373-1300, United States

Location

Cleveland Clinic - Wooster

Wooster, Ohio, 44691, United States

Location

United States Air Force Medical Center - Wright-Patterson

Wright-Patterson AFB, Ohio, 45433-5529, United States

Location

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, 45385, United States

Location

Tod Children's Hospital - Forum Health

Youngstown, Ohio, 44501, United States

Location

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030, United States

Location

Providence Milwaukie Hospital

Milwaukie, Oregon, 97222, United States

Location

Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center

Portland, Oregon, 97210, United States

Location

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, 97213-2967, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Legacy Emanuel Hospital and Health Center & Children's Hospital

Portland, Oregon, 97227, United States

Location

Oregon Health & Science University Cancer Institute

Portland, Oregon, 97239-3098, United States

Location

Legacy Meridian Park Hospital

Tualatin, Oregon, 97062, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

AnMed Cancer Center

Anderson, South Carolina, 29621, United States

Location

McLeod Regional Medical Center

Florence, South Carolina, 29501, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Medical X-Ray Center, PC

Sioux Falls, South Dakota, 57105, United States

Location

Sioux Valley Hospital and University of South Dakota Medical Center

Sioux Falls, South Dakota, 57117-5039, United States

Location

Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

Kingsport, Tennessee, 37662, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236, United States

Location

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

Location

Danville Regional Medical Center

Danville, Virginia, 24541, United States

Location

Southwest Virginia Regional Cancer Center

Norton, Virginia, 24273, United States

Location

St. Joseph Cancer Center

Bellingham, Washington, 98225, United States

Location

Olympic Hematology and Oncology

Bremerton, Washington, 98310, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98104, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Minor and James Medical, PLLC

Seattle, Washington, 98104, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98122-4307, United States

Location

Polyclinic First Hill

Seattle, Washington, 98122, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States

Location

Providence Cancer Center at Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

Providence Cancer Center at Holy Family Hospital

Spokane, Washington, 99207, United States

Location

Southwest Washington Medical Center Cancer Center

Vancouver, Washington, 98668, United States

Location

Green Bay Oncology, Limited at St. Vincent Hospital

Green Bay, Wisconsin, 54301-3526, United States

Location

Green Bay Oncology, Limited at St. Mary's Hospital

Green Bay, Wisconsin, 54303, United States

Location

St. Mary's Hospital Medical Center - Green Bay

Green Bay, Wisconsin, 54303, United States

Location

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, 54307-3508, United States

Location

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

Bay Area Cancer Care Center at Bay Area Medical Center

Marinette, Wisconsin, 54143, United States

Location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

Location

Green Bay Oncology, Limited - Oconto Falls

Oconto Falls, Wisconsin, 54154, United States

Location

Marshfield Clinic - Indianhead Center

Rice Lake, Wisconsin, 54868, United States

Location

Green Bay Oncology, Limited - Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235, United States

Location

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, 82801, United States

Location

Related Publications (1)

  • Ryan CW, von Mehren M, Rankin CJ, et al.: Phase II intergroup study of sorafenib (S) in advanced soft tissue arcomas (STS): SWOG 0505. [Abstract] J Clin Oncol 26 (Suppl 15): A-10532, 2008.

    RESULT

MeSH Terms

Conditions

SarcomaHemangiosarcomaLeiomyosarcomaLiposarcomaHemangiopericytoma, Malignant

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueNeoplasms, Muscle TissueNeoplasms, Adipose Tissue

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Study Statistician
Organization
SWOG Statistical Center

Study Officials

  • Margaret von Mehren, MD

    Fox Chase Cancer Center

    STUDY CHAIR
  • George D. Demetri, MD

    Dana-Farber Cancer Institute

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

March 1, 2006

Primary Completion

April 1, 2008

Study Completion

September 1, 2012

Last Updated

May 15, 2014

Results First Posted

November 1, 2012

Record last verified: 2013-01

Locations