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Recurrent MelanomaPhase 2NCT00281957

Sorafenib With Either Temsirolimus or Tipifarnib in Treating Patients With Stage IV Malignant Melanoma That Cannot Be Removed By Surgery

A Phase 2 study testing sorafenib tosylate, tipifarnib and temsirolimus in people with Recurrent Melanoma and Stage IV Melanoma, run by National Cancer Institute (NCI) at 173 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This randomized phase II trial is studying how well giving sorafenib together with either temsirolimus or tipifarnib works in treating patients with stage IV melanoma that cannot be removed by surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Melanoma, Stage IV Melanoma
What is being tested?
sorafenib tosylate, tipifarnib and temsirolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
109 participants
Where
173 sitesUnited States
Study dates
Aug 2007to Jan 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Criteria:

  • Histologically confirmed malignant melanoma of cutaneous origin
  • Patients with unknown primary allowed
  • Stage IV disease
  • Measurable disease by physical examination, CT scan, MRI or plain x-ray
  • Unresectable disease
  • Residual or recurrent disease after prior surgery for stage IV disease allowed
  • Residual tumor at the site of incomplete resection may be included only as nonmeasurable disease
  • Must have serum lactate dehydrogenase (LDH) levels measured
  • Must have tissue specimens available
  • Negative brain CT scan or MRI within the past 42 days
  • Creatinine =< 1.5 times ULN
  • Absolute neutrophil count >= 1,000/mm^3
  • Platelet count >= 100,000/mm^3
  • Hemoglobin >= 9.0 g/dL
  • Fasting cholesterol =< 350 mg/dL (lipid-lowering agents allowed)
  • Triglycerides =< 300 mg/dL (lipid-lowering agents allowed)
  • No symptomatic sensory neuropathy >= grade 2
  • No evidence of bleeding diathesis or coagulopathy
  • No congestive heart failure
  • No myocardial infarction within the past 2 months
  • No New York Heart Association class III or IV heart disease
  • No condition that impairs the ability to swallow pills (e.g., gastrointestinal tract disease resulting in an inability to take oral medication, requirement for IV alimentation, prior surgical procedure affecting absorption, or active peptic ulcer disease)
  • No known allergy to imidazoles (e.g. clotrimazole, ketoconazole, miconazole, or econazole)
  • No history of allergic reaction to compounds of similar chemical or biologic composition as tipifarnib
  • No hypertension with systolic blood pressure (BP) > 140 mm Hg or diastolic BP > 90 mm Hg
  • Patients with well-controlled hypertension allowed
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No uncontrolled diabetes
  • No uncontrolled diabetes
  • No active uncontrolled infection
  • No other severe or uncontrolled medical disease
  • No psychologic or medical condition that would preclude study treatment or compliance
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, adequately treated stage I or II cancer that is in complete remission, or carcinoma in situ of the cervix
  • At least 90 days since prior adjuvant therapy, including cytotoxic agents
  • At least 28 days since prior radiotherapy
  • At least 28 days since prior surgery to remove the tumor
  • No prior systemic therapy for stage IV melanoma
  • No prior therapy with agents targeting farnesyl transferase, the MAP kinase pathway, or vascular endothelial growth factors (VEGF) or receptors (VEFGR), including drugs such as sorafenib, temsirolimus, or tipifarnib
  • Concurrent lipid-lowering agents allowed
  • Not requiring full-dose anticoagulation for recent thrombotic event
  • No concurrent highly active antiretroviral therapy (HAART) in HIV-positive patients
  • No concurrent use of any of the following: dilantin; carbamazepine; Phenobarbital; rifampin; hypericum perforatum (St. John's wort); ketoconazole; itraconazole; ritonavir; cyclosporine; phenytoin; grapefruit juice
  • Bilirubin =< 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT =< 2.5 times ULN (5 times ULN if hepatic metastases)
  • No history of brain metastases
  • Zubrod performance status 0-1

Trial locations and contacts

173 sites in 1 country.

173 sites in 1 country

United States173 sites

  • McFarland Clinic PC-William R Bliss Cancer Center

    Ames, Iowa, 50010

  • AnMed Health Hospital

    Anderson, South Carolina, 29621

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Hospital District Sixth of Harper County

    Anthony, Kansas, 67003

  • Mission Hospital-Memorial Campus

    Asheville, North Carolina, 28801

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Constantinou, Costas L MD (UIA Investigator)

    Bettendorf, Iowa, 52722

  • Spectrum Health Big Rapids Hospital

    Big Rapids, Michigan, 49307

  • Montana Cancer Consortium CCOP

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies PC

    Billings, Montana, 59102

  • Billings Clinic

    Billings, Montana, 59107-7000

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Harrison HealthPartners Hematology and Oncology-Bremerton

    Bremerton, Washington, 98310

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Southeast Missouri Hospital

    Cape Girardeau, Missouri, 63701

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Eden Hospital Medical Center

    Castro Valley, California, 94546

  • Valley Medical Oncology Consultants-Castro Valley

    Castro Valley, California, 94546

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Genesis Medical Center - East Campus

    Davenport, Iowa, 52803

  • Genesis Medical Center - West Campus

    Davenport, Iowa, 52804

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Exempla Saint Joseph Hospital

    Denver, Colorado, 80218

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • Colorado Cancer Research Program CCOP

    Denver, Colorado, 80224-2522

  • Mercy Capitol

    Des Moines, Iowa, 50307

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa Oncology Research Association CCOP

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Valley Medical Oncology Consultants-Fremont

    Fremont, California, 94538

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81502

  • Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Berdeaux, Donald MD (UIA Investigator)

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Northern Montana Hospital

    Havre, Montana, 59501

  • Hays Medical Center

    Hays, Kansas, 67601

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Holland Community Hospital

    Holland, Michigan, 49423

  • Promise Regional Medical Center-Hutchinson

    Hutchinson, Kansas, 65702

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Centerpoint Medical Center LLC

    Independence, Missouri, 64057

  • Joliet Oncology-Hematology Associates Limited

    Joliet, Illinois, 60435

  • Glacier Oncology PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Providence Medical Center

    Kansas City, Kansas, 66112

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Radiation Oncology Practice Corporation South

    Kansas City, Missouri, 64114

  • Radiation Oncology Practice Corporation - North

    Kansas City, Missouri, 64154

  • Good Samaritan Hospital

    Kearney, Nebraska, 68847

  • Columbia Basin Hematology and Oncology PLLC

    Kennewick, Washington, 99336

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Saint Anthony Hospital

    Lakewood, Colorado, 80228

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Nevada Cancer Research Foundation CCOP

    Las Vegas, Nevada, 89106

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Cancer Centers of Central Florida PA

    Leesburg, Florida, 34788

  • Nebraska Cancer Research Center

    Lincoln, Nebraska, 68510

  • Meeker County Memorial Hospital

    Litchfield, Minnesota, 55355

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Longmont United Hospital

    Longmont, Colorado, 80501

  • University of Southern California/Norris Cancer Center

    Los Angeles, California, 90033

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Dean Hematology and Oncology Clinic

    Madison, Wisconsin, 53717

  • Mansfield General Hospital-MedCentral Health System

    Mansfield, Ohio, 44903

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Franciscan Saint Anthony Health-Michigan City

    Michigan City, Indiana, 46360

  • Orange Regional Medical Center

    Middletown, New York, 10940

  • Virginia Piper Cancer Institute

    Minneapolis, Minnesota, 55407

  • Community Medical Hospital

    Missoula, Montana, 59801

  • Montana Cancer Specialists

    Missoula, Montana, 59802

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Garneau, Stewart C MD (UIA Investigator)

    Moline, Illinois, 61265

  • Porubcin, Michael MD (UIA Investigator)

    Moline, Illinois, 61265

  • Sharis, Christine M MD (UIA Investigator)

    Moline, Illinois, 61265

  • Stoffel, Thomas J MD (UIA Investigator)

    Moline, Illinois, 61265

  • Louisiana State University Sciences Center- Monroe

    Monroe, Louisiana, 71210

  • Skagit Valley Hospital

    Mount Vernon, Washington, 98274

  • El Camino Hospital

    Mountain View, California, 94040

  • Mercy Health Partners-Hackley Campus

    Muskegon, Michigan, 49442

  • Mercy Health Mercy Campus

    Muskegon, Michigan, 49444

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Southwest VA Regional Cancer Center

    Norton, Virginia, 24273

  • Highland General Hospital

    Oakland, California, 94602

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • Bay Area Breast Surgeons Inc

    Oakland, California, 94609

  • Bay Area Tumor Institute CCOP

    Oakland, California, 94609

  • Larry G Strieff MD Medical Corporation

    Oakland, California, 94609

  • Tom K Lee Inc

    Oakland, California, 94609

  • Olathe Cancer Center

    Olathe, Kansas, 66061

  • Radiation Oncology Practice Corporation Southwest

    Overland Park, Kansas, 66210

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Valley Care Health System - Pleasanton

    Pleasanton, California, 94588

  • Valley Medical Oncology Consultants

    Pleasanton, California, 94588

  • Adventist Medical Center

    Portland, Oregon, 97216

  • SWOG

    Portland, Oregon, 97239

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Saint Mary Corwin Medical Center

    Pueblo, Colorado, 81004

  • Sutter Roseville Medical Center

    Roseville, California, 95661

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • Sutter General Hospital

    Sacramento, California, 95816

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • Doctors Medical Center- JC Robinson Regional Cancer Center

    San Pablo, California, 94806

  • Memorial Health University Medical Center

    Savannah, Georgia, 31403

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Minor and James Medical PLLC

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Seattle, Washington, 98109

  • Group Health Cooperative-Seattle

    Seattle, Washington, 98112

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122-4307

  • The Polyclinic

    Seattle, Washington, 98122

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • United General Hospital

    Sedro-Woolley, Washington, 98284

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Highland Clinic

    Shreveport, Louisiana, 71105

  • Louisiana State University Health Sciences Center Shreveport

    Shreveport, Louisiana, 71130

  • Siouxland Hematology Oncology Associates

    Sioux City, Iowa, 51101

  • Mercy Medical Center-Sioux City

    Sioux City, Iowa, 51104

  • Saint Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Upstate Carolina CCOP

    Spartanburg, South Carolina, 29303

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • North Suburban Medical Center

    Thornton, Colorado, 80229

  • Stormont-Vail Regional Health Center

    Topeka, Kansas, 66604

  • Saint Francis Hospital and Medical Center - Topeka

    Topeka, Kansas, 66606

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Carle Clinic-Urbana Main

    Urbana, Illinois, 61801

  • South Georgia Medical Center

    Valdosta, Georgia, 31603

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801

  • Exempla Lutheran Medical Center

    Wheat Ridge, Colorado, 80033

  • Associates In Womens Health

    Wichita, Kansas, 67208

  • Cancer Center of Kansas-Wichita Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas - Main Office

    Wichita, Kansas, 67214

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wichita CCOP

    Wichita, Kansas, 67214

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Metro Health Hospital

    Wyoming, Michigan, 49519

Other trials in United States

About this study

Official title: A Randomized Phase II Trial of BAY 43-9006 (Sorafenib; NSC-724772) With Either CCI-779 (Temsirolimus; NSC-683864) or R115777 (Tipifarnib; NSC-702818) in Metastatic Melanoma

This randomized phase II trial is studying how well giving sorafenib together with either temsirolimus or tipifarnib works in treating patients with stage IV melanoma that cannot be removed by surgery. Sorafenib, temsirolimus, and tipifarnib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib and tipifarnib may also stop the growth of tumor by blocking blood flow to the tumor. It is not yet known whether sorafenib is more effective when given together with temsirolimus or tipifarnib in treating patients with malignant melanoma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Compare the response rate (confirmed and unconfirmed and complete and partial) in patients with unresectable stage IV malignant melanoma treated with sorafenib in combination with either temsirolimus or tipifarnib.

II. Compare the 4-month progression-free survival rate of patients treated with these regimens.

III. Compare the safety and tolerability of these regimens, with an emphasis on long-term side effects and toxic effects, in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to metastatic (M) stage (M1a/b vs M1c). Patients are randomized to 1 of 2 treatment arms.

ARM I (reopened to accrual as of 8/15/2009): Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.

ARM II (closed to accrual as of 8/15/2009): Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 3 years.

Being tested
sorafenib tosylate, tipifarnib, temsirolimus
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sorafenib tosylateDrug

    Also called BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar

    Given orally

  • tipifarnibDrug

    Also called R115777, Zarnestra

    Given orally

  • temsirolimusDrug

    Also called CCI-779, cell cycle inhibitor 779, Torisel

    Given IV

Study groups in NCT00281957
Study groupRoleWhat they receive
Arm I (sorafenib, temsirolimus)ExperimentalPatients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
Receives: Drug: sorafenib tosylate; Drug: temsirolimus
Arm II (sorafenib, tipifarnib)ExperimentalPatients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
Receives: Drug: sorafenib tosylate; Drug: tipifarnib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response Rate (Complete and Partial)

    Complete response corresponds to complete disappearance of all measurable and non-measurable lesions with no new lesions. Partial response corresponds to greater than or equal to 30fi decrease of sum of longest diameter of all target measurable lesions with no new lesion and non unequivocal progression of non-measurable disease.

    Measured: Every 8 weeks until progression

  2. 4-month Progression-free Survival

    Progression was defined as one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed, unequivocal progression of non-measurable disease, appearance of any new lesions, death due to disease without prior documentation of progression and without symptomatic deterioration.

    Measured: 4 months after registration

Secondary outcomes (2)

  1. One-year Overall Survival

    Measured: One year after registration

  2. Toxicity

    Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event

    Measured: Weekly during first cycle, every two weeks during the second cycle, and once a cycle further cycles (one cycle = 4 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2006 (estimated)
  2. Study startAug 2007
  3. Primary completionDec 2010
  4. Study completionJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00281957
Sponsor's protocol ID
NCI-2009-00774
Other IDs
NCI-2009-00774, S0438, CDR0000454925, S0438, S0438, U10CA032102
Status last verified
Apr 2013
First submitted
24 Jan 2006
Last updated
20 May 2014

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sorafenib tosylate, tipifarnib and temsirolimus in people with Recurrent Melanoma and Stage IV Melanoma, run by National Cancer Institute (NCI) at 173 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 173 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Rate (Complete and Partial) (time frame: Every 8 weeks until progression). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00281957.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2014.

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