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Breast CancerPhase 2NCT00410813

S0622, Dasatinib in Treating Patients With Stage IV Breast Cancer That Has Spread to the Bone

A Phase 2 study testing dasatinib in people with Breast Cancer and Metastatic Cancer, run by SWOG Cancer Research Network at 117 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

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This randomized phase II trial is studying two different schedules of dasatinib to compare how well they work in treating patients with stage IV breast cancer that has spread to the bone. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Metastatic Cancer
What is being tested?
dasatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
117 sitesUnited States
Study dates
Mar 2007to Jan 2014
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

DISEASE CHARACTERISTICS:

  • Diagnosis of breast carcinoma meeting the following criteria:
  • Stage IV disease
  • Bone metastasis-predominant disease, defined as the presence of ≥ 1 bone metastasis with or without nonbone (visceral or soft tissue) disease where the number of bone metastases is at least the number of measurable visceral target lesions
  • Visceral disease that does not cause a reduction in ECOG performance status allowed
  • Must meet 1 of the following criteria:
  • Measurable disease within the past 28 days
  • Nonmeasurable disease with rising serum CA 15-3, CA 27-29, CEA, or CA-125 documented by 2 consecutive measurements taken ≥ 14 days apart with the most recent measurement being within the past 42 days
  • These measurements need not be consecutive, and the prior measurement could have been months to years prior to the current measurement if the marker is considered by the investigator to reflect disease progression
  • The second serum marker value must be greater than the institution's upper limit of normal and show ≥ a 20% increase over the first measurement
  • No symptomatic brain or CNS metastases
  • Prior CNS or brain metastasis allowed provided it was treated with radiotherapy ≥ 8 weeks ago
  • No pleural or pericardial effusion
  • Hormone receptor status known
  • Estrogen receptor- and/or progesterone receptor-positive disease must have progressed on ≥ 1 hormonal therapy in the metastatic setting

PATIENT CHARACTERISTICS:

  • Male or female
  • Menopausal status not specified
  • Zubrod performance status 0-2
  • QTc < 450 msec by EKG
  • Ejection fraction ≥ 50% by MUGA or 2-dimensional echocardiogram with no significant abnormalities within the past 12 weeks for patients on trastuzumab
  • No active infection requiring systemic therapy
  • No uncontrolled concurrent condition that would preclude the ability to take oral medication, including the following:
  • Nausea
  • Vomiting
  • Diarrhea
  • Lack of physical integrity of the upper gastrointestinal tract
  • Malabsorption syndrome
  • No clinically significant cardiac disease, including the following:
  • Congestive heart failure
  • Symptomatic coronary artery disease
  • Cardiac arrhythmias not well controlled
  • Myocardial infarction within the past 12 months
  • No concurrent active malignancy
  • Prior malignancies allowed provided the patient is currently disease-free
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 3 months after completion of study therapy

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior RankL inhibitor therapy
  • No more than 1 prior cytotoxic chemotherapy for metastatic disease
  • At least 3 weeks since prior chemotherapy and recovered
  • At least 1 week since prior radiotherapy to non-CNS disease and recovered
  • At least 3 weeks since prior and no concurrent intravenous bisphosphates (e.g., zoledronate)
  • At least 7 days since prior and no concurrent antiplatelet agents, including any of the following*:
  • Anticoagulants (e.g., tirofiban, eptifibatide, ticlopidine)
  • Aspirin or aspirin-containing combinations
  • Dipyridamole
  • Epoprostenol
  • Clopidogrel
  • Cilostazol
  • Abciximab NOTE: *Nonsteroidal anti-inflammatory drugs and medically indicated platelet-inhibiting medication allowed
  • At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
  • HIV protease inhibitors (e.g., amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir)
  • Select antibiotics (e.g., ciprofloxacin, clarithromycin, doxycycline, enoxacin, isoniazid, telithromycin)
  • Azole antifungals (e.g., itraconazole, ketoconazole, miconazole, voriconazole)
  • Select anesthetics (e.g., ketamine, propofol)
  • Hypericum perforatum (St. John's wort)
  • Nefazodone
  • Nicardipine
  • Diclofenac
  • Quinidine
  • Imatinib mesylate
  • At least 7 days since prior and no concurrent medications that prolong the QTc interval, including any of the following:
  • Antiarrhythmic agents (e.g., quinidine, procainamide, disopyramide phosphate, amiodarone, sotalol hydrochloride, ibutilide, dofetilide)
  • Antipsychotic agents (e.g., chlorpromazine, mesoridazine, thioridazine, pimozide, haloperidol, droperidol)
  • Select antibiotics (e.g., erythromycin, clarithromycin, sparfloxacin, pentamidine)
  • Narcotic analgesics (e.g., levomethadyl, methadone, domperidone)
  • Calcium channel blockers (e.g., bepridil, lidoflazine)
  • Antimalarial agents (e.g., halofantrine, chloroquine)
  • Parasympathomimetic agents (e.g., cisapride)
  • Arsenic trioxide
  • No other concurrent antineoplastic therapy for breast cancer, including any of the following:
  • Radiotherapy
  • Chemotherapy
  • Immunotherapy
  • Biologic therapy
  • Hormonal therapy
  • Gene therapy
  • No concurrent grapefruit juice consumption
  • No concurrent short-acting antacid agents within 2 hours of dasatinib administration
  • Concurrent trastuzumab (Herceptin®) therapy for HER-2 positive patients allowed provided patients have been on continuous trastuzumab for ≥ 12 weeks

Trial locations and contacts

117 sites in 1 country.

117 sites in 1 country

United States117 sites

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Lovelace Medical Center - Downtown

    Albuquerque, New Mexico, 87102

  • Hematology Oncology Associates, PC

    Albuquerque, New Mexico, 87106

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87131-5636

  • Alaska Regional Hospital Cancer Center

    Anchorage, Alaska, 99508

  • Providence Cancer Center

    Anchorage, Alaska, 99508

  • AnMed Cancer Center

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • University of Colorado Cancer Center at UC Health Sciences Center

    Aurora, Colorado, 80045

  • Mary Rutan Hospital

    Bellefontaine, Ohio, 43311

  • Highlands Oncology Group - Springdale

    Bentonville, Arkansas, 72712

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59102

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Boston University Cancer Research Center

    Boston, Massachusetts, 02118

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Eden Medical Center

    Castro Valley, California, 94546

  • Valley Medical Oncology Consultants - Castro Valley

    Castro Valley, California, 94546

  • Providence Centralia Hospital

    Centralia, Washington, 98531-9027

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Medical Center Cancer Care

    Columbus, Ohio, 43215

  • Mount Carmel Health - West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Genesis Regional Cancer Center at Genesis Medical Center

    Davenport, Iowa, 52803

  • Genesis Medical Center - West Campus

    Davenport, Iowa, 52804

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Cancer Care Center of Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • St. Francis Hospital

    Federal Way, Washington, 98003

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Valley Medical Oncology

    Fremont, California, 94538

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Big Sky Oncology

    Great Falls, Montana, 59405-5309

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Study site

    Great Falls, Montana, 59405

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Northern Montana Hospital

    Havre, Montana, 59501

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • University of Mississippi Cancer Clinic

    Jackson, Mississippi, 39216

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37662

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County

    Martinsville, Virginia, 24115

  • Tibotec Therapeutics - Division of Ortho Biotech Products, LP

    Marysville, California, 95901

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

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

    Missoula, Montana, 59807

  • Providence Cancer Center at Providence Hospital

    Mobile, Alabama, 36608

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • El Camino Hospital Cancer Center

    Mountain View, California, 94040

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055

  • Southwest Virginia Regional Cancer Center at Wellmonth Health

    Norton, Virginia, 24273

  • Highland General Hospital

    Oakland, California, 94602

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • Bay Area Breast Surgeons, Incorporated

    Oakland, California, 94609

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609

  • Larry G Strieff MD Medical Corporation

    Oakland, California, 94609

  • Tom K Lee, Incorporated

    Oakland, California, 94609

  • Providence St. Peter Hospital Regional Cancer Center

    Olympia, Washington, 98506-5166

  • Valley Care Medical Center

    Pleasanton, California, 94588

  • Valley Medical Oncology Consultants - Pleasanton

    Pleasanton, California, 94588

  • St. Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • Good Samaritan Cancer Center

    Puyallup, Washington, 98372

  • Interlakes Oncology/Hematology PC

    Rochester, New York, 14623

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Seton Cancer Institute at Saint Mary's - Saginaw

    Saginaw, Michigan, 48601

  • Salem Hospital Regional Cancer Care Services

    Salem, Oregon, 97309-5014

  • Tammy Walker Cancer Center at Salina Regional Health Center

    Salina, Kansas, 67401

  • Doctors Medical Center - San Pablo Campus

    San Pablo, California, 94806

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Regional Cancer Center at Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • Community Hospital of Springfield and Clark County

    Springfield, Ohio, 45505

  • Franciscan Cancer Center at St. Joseph Medical Center

    Tacoma, Washington, 98405-3004

  • Allenmore Hospital

    Tacoma, Washington, 98405

  • CCOP - Northwest

    Tacoma, Washington, 98405

  • MultiCare Regional Cancer Center at Tacoma General Hospital

    Tacoma, Washington, 98405

  • St. Clare Hospital

    Tacoma, Washington, 98499

  • Pearlman Comprehensive Cancer Center at South Georgia Medical Center

    Valdosta, Georgia, 31603

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Mount Carmel St. Ann's Cancer Center

    Westerville, Ohio, 43081

  • Genesis - Good Samaritan Hospital

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone Metastasis Predominant Metastatic Breast Cancer

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This randomized phase II trial is studying two different schedules of dasatinib to compare how well they work in treating patients with stage IV breast cancer that has spread to the bone.

Read the detailed description

OBJECTIVES:

  • Compare the progression-free survival of patients with stage IV bone metastasis-predominant breast cancer treated with 1 of 2 treatment schedules of dasatinib.
  • Compare the response rate (complete and partial, confirmed and unconfirmed) in patients treated with these regimens.
  • Compare the MUC-1 antigen response rate (CA 15-3 or CA 27-29) in patients treated with these regimens.
  • Compare the circulating tumor cell response rate in patients treated with these regimens.
  • Compare the anti-osteoclast activity, as measured by changes in bone turnover markers, in patients treated with these regimens.
  • Compare the frequency and severity of toxicities of these regimens in these patients.
  • Compare the pain profiles of these patients and explore changes over time.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to concurrent trastuzumab (Herceptin®) treatment (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral dasatinib once daily.
  • Arm II: Patients receive oral dasatinib twice daily. In both treatment arms, treatment continues for at least 24 weeks in the absence of disease progression or unacceptable toxicity.

Blood samples are acquired from patients once weekly in weeks 1, 4, 8, 16, and 24. Samples are analyzed for tumor markers, circulating tumor cells, and bone markers.

Patients complete a self-reported brief pain inventory questionnaire at baseline and once in weeks 8, 16, and 24.

After completion of study treatment, patients are followed every 3-6 months for up to 2 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Being tested
dasatinib
Keywords
stage IV breast cancer, male breast cancer, recurrent breast cancer, bone metastases
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis, Breast Neoplasms, Male

What participants receive

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

Study groups in NCT00410813
Study groupRoleWhat they receive
Arm IExperimentalPatients receive oral dasatinib once daily.
Receives: Drug: dasatinib
Arm IIExperimentalPatients receive oral dasatinib twice daily.
Receives: Drug: dasatinib

What is being measured

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

  1. Progression-free Survival

    RECIST progression defined as 20% increase in the sum of longest diameters of target measurable lesions over the smallest sum observed, unequivocal progression of non-measurable disease, the appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration, development of one or more new bone lesions from baseline, or symptomatic deterioration related to disease progression. Time from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact.

    Measured: Up to 2 years

Secondary outcomes (11)

  1. Response Rate (Complete and Partial, Confirmed and Unconfirmed)

    Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms, normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 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. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.

    Measured: Up to 2 years

  2. MUC-1 Antigen Response

    MUC-1 Complete Response is reduction in MUC-1 such that MUC-1 <= ULN. MUC-1 Partial Response is greater than or equal to a 50% reduction in MUC-1 from baseline, but not qualifying as a CR. MUC-1 Progression is greater than or equal to a 50% increase in MUC-1 from baseline. MUC-1 Stable Disease is MUC-1 response not qualifying as CR, PR, or Progression.

    Measured: at 4, 8, 16, and 24 weeks

  3. Circulating Tumor Cells (CTC) Response Rate

    CTC response at 4 weeks is defined as the number of patients with initially elevated CTCs (>= 5 cells/7.5 ml), whose CTC level drops to < 5.

    Measured: Up to 4 weeks

  4. Change in Serum Bone Turnover Markers Over Time -- NTx

    Analysis included mean values of the serum biomarker NTx at baseline, 4, and 8 weeks.

    Measured: at baseline, 4, and 8 weeks

  5. Change in Serum Bone Turnover Markers Over Time -- BAP

    Analysis included mean values of the serum biomarker BAP at baseline, 4, and 8 weeks.

    Measured: at baseline, 4, and 8 weeks

  6. Change in Serum Bone Turnover Markers Over Time

    Analysis included mean values of the serum biomarkers sRANKL, IL-6, DKK, VEGF at baseline, 4, and 8 weeks.

    Measured: at baseline, 4, and 8 weeks

  7. Change in Serum Bone Turnover Markers Over Time -- OC

    Analysis included mean values of the serum biomarker OC at baseline, 4, and 8 weeks.

    Measured: at baseline, 4, and 8 weeks

  8. Change in Serum Bone Turnover Markers Over Time -- OPG

    Analysis included mean values of the serum biomarker OPG at baseline, 4, and 8 weeks.

    Measured: at baseline, 4, and 8 weeks

  9. Change in Serum Bone Turnover Markers Over Time -- TRAP

    Analysis included mean values of the serum biomarker TRAP at baseline, 4, and 8 weeks.

    Measured: at baseline, 4, and 8 weeks

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

    Only adverse events that are possibly, probably or definitely related to study drug are reported.

    Measured: Up to 2 years

  11. Mean Patient-reported Pain

    Patient's rating of "worst pain" experienced between prestudy and week 24. Changes of >=2 points on the Brief Pain Inventory (BPI) are of interest. Pain is self-reported on the Brief Pain Inventory Short Form, on a 0-10 response scale, with higher scores reflecting more pain and more interference with functioning.

    Measured: Baseline, 8, 16, and 24 weeks

Timeline

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

  1. First posted13 Dec 2006 (estimated)
  2. Study startMar 2007
  3. Primary completionJan 2013
  4. Study completionJan 2014

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
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00410813
Sponsor's protocol ID
CDR0000520348
Other IDs
S0622, U10CA032102
Status last verified
May 2017
First submitted
11 Dec 2006
Last updated
2 Jul 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dasatinib in people with Breast Cancer and Metastatic Cancer, run by SWOG Cancer Research Network at 117 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 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 2 Jul 2017). 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?

Progression-free Survival (time frame: Up to 2 years). 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 NCT00410813.

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 2 Jul 2017; AzTrials last refreshed its copy on 8 Nov 2026.

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