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Acral Lentiginous MelanomaPhase 2NCT00937937

Dinaciclib in Treating Patients With Stage IV Melanoma

A Phase 2 study testing Dinaciclib in people with Acral Lentiginous Melanoma and Cutaneous Nodular Melanoma, run by National Cancer Institute (NCI) at 190 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This phase II trial is studying the side effects and how well dinaciclib works in treating patients with stage IV melanoma. Dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dinaciclib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
190 sitesUnited States
Study dates
1 Jul 2009to 19 Mar 2027
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

Who may be able to join

  • Biopsy-confirmed malignant melanoma
  • Stage IV disease
  • Cutaneous or mucosal origin
  • Melanoma of unknown primary allowed
  • No ocular melanoma
  • Measurable or non-measurable disease
Show all 30Show fewer
  • No prior or concurrent brain metastases as confirmed by CT scan or MRI
  • Zubrod performance status 0-1
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL
  • Serum bilirubin ≤ 1.5 times upper limit of normal (ULN) (including patients with hepatic metastases)
  • SGOT or SGPT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of hepatic metastases)
  • Serum creatinine ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
  • No prior therapy with a cyclin-dependent kinase inhibitor
  • At least 14 days since prior radiotherapy
  • At least 28 days since prior systemic chemotherapy
  • At least 28 days since prior adjuvant systemic therapy
  • At least 28 days since prior surgery
  • No more than 1 prior systemic therapy regimen (chemotherapy, biologic/immunotherapy, hormonal therapy, or a combination regimen) for stage IV melanoma and any side effects must have resolved to ≤ grade 1
  • Any number of prior adjuvant systemic therapy regimens allowed, including interferon alfa-2b, GM-CSF, chemotherapy, and chemobiotherapy
  • Therapy for stage IV resected free-of-disease will be considered adjuvant therapy
  • Prior radiotherapy allowed provided any side effects have resolved to ≤ grade 1
  • Prior surgery (for both the primary and stage IV disease) allowed provided side effects have resolved to ≤ grade 1
  • No other concurrent or planned non-study treatment (including chemotherapy, hormonal therapy, biologic therapy, or radiotherapy)
  • No concurrent CYP3A4 inhibitors or inducers
  • No concurrent grapefruit or grapefruit juice

Who cannot join

None listed.

Trial locations and contacts

190 sites in 1 country.

190 sites in 1 country

United States190 sites

  • OSF Saint Anthony's Health Center

    Alton, Illinois, 62002

  • Michigan Cancer Research Consortium NCORP

    Ann Arbor, Michigan, 48106

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

  • Baton Rouge General Medical Center

    Baton Rouge, Louisiana, 70806

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • Franciscan Saint Francis Health-Beech Grove

    Beech Grove, Indiana, 46107

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Saint Charles Health System

    Bend, Oregon, 97701

  • Spectrum Health Big Rapids Hospital

    Big Rapids, Michigan, 49307

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Montana Cancer Consortium NCORP

    Billings, Montana, 59102

  • Saint Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • Boca Raton Comprehensive Cancer Center

    Boca Raton, Florida, 33486

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • 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

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Dayton NCI Community Oncology Research Program

    Dayton, Ohio, 45459

  • Corewell Health Dearborn Hospital

    Dearborn, Michigan, 48124

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Genesys Regional Medical Center-West Flint Campus

    Flint, Michigan, 48532

  • McLeod Regional Medical Center

    Florence, South Carolina, 29506

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Valley Medical Oncology Consultants-Fremont

    Fremont, California, 94538

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • Cancer Research Consortium of West Michigan NCORP

    Grand Rapids, Michigan, 49503

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Berdeaux, Donald MD (UIA Investigator)

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Greenville Health System Cancer Institute-Andrews

    Greenville, South Carolina, 29601

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Self Regional Healthcare

    Greenwood, South Carolina, 29646

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

  • Northern Montana Hospital

    Havre, Montana, 59501

  • HaysMed

    Hays, Kansas, 67601

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Hutchinson Regional Medical Center

    Hutchinson, Kansas, 67502

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Allegiance Health

    Jackson, Michigan, 49201

  • Glacier Oncology PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Logan Health Medical Center

    Kalispell, Montana, 59901

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • University Health Truman Medical Center

    Kansas City, Missouri, 64108

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Saint Joseph Health Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Heartland Hematology and Oncology Associates Incorporated

    Kansas City, Missouri, 64118

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Wellmont Holston Valley Hospital and Medical Center

    Kingsport, Tennessee, 37660

  • Covenant Health Cancer Centers

    Knoxville, Tennessee, 37916

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Nevada Cancer Institute-Summerlin Campus

    Las Vegas, Nevada, 89135

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67905

  • Liberty Hospital

    Liberty, Missouri, 64068

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Sovah Health Martinsville

    Martinsville, Virginia, 24112

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Montana Cancer Specialists

    Missoula, Montana, 59802

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Community Medical Center

    Missoula, Montana, 59804

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Providence Hospital

    Mobile, Alabama, 36608

  • SSM Health Good Samaritan

    Mount Vernon, Illinois, 62864

  • Skagit Valley Hospital

    Mount Vernon, Washington, 98274

  • El Camino Hospital

    Mountain View, California, 94040

  • Trinity Health Muskegon Hospital

    Muskegon, Michigan, 49444

  • Louisiana State University Health Science Center

    New Orleans, Louisiana, 70112

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Ballad Health Cancer Care - Norton

    Norton, Virginia, 24273

  • Wilma Chan Highland Hospital

    Oakland, California, 94602

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • Bay Area Tumor Institute

    Oakland, California, 94609

  • Hematology and Oncology Associates-Oakland

    Oakland, California, 94609

  • Tom K Lee Inc

    Oakland, California, 94609

  • Olathe Cancer Center

    Olathe, Kansas, 66061

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Saint Luke's South Hospital

    Overland Park, Kansas, 66213

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • FirstHealth of the Carolinas-Moore Regional Hospital

    Pinehurst, North Carolina, 28374

  • Mercy Hospital Pittsburg

    Pittsburg, Kansas, 66762

  • Valley Care Health System - Pleasanton

    Pleasanton, California, 94588

  • Valley Medical Oncology Consultants

    Pleasanton, California, 94588

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

  • Lake Huron Medical Center

    Port Huron, Michigan, 48060

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Adventist Medical Center

    Portland, Oregon, 97216

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Harrison HealthPartners Hematology and Oncology-Poulsbo

    Poulsbo, Washington, 98370

  • Kansas City NCI Community Oncology Research Program

    Prairie Village, Kansas, 66208

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Reid Health

    Richmond, Indiana, 47374

  • University of Rochester

    Rochester, New York, 14642

  • Highlands Oncology Group - Rogers

    Rogers, Arkansas, 72758

  • MyMichigan Medical Center Saginaw

    Saginaw, Michigan, 48601

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Salem Hospital

    Salem, Oregon, 97301

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • Salina Regional Health Center

    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, 31404

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia, 31405

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Minor and James Medical PLLC

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • Kaiser Permanente Washington

    Seattle, Washington, 98112

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • AdventHealth Shawnee Mission

    Shawnee Mission, Kansas, 66204

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Saint Joseph Medical Center Hematology and Oncology - Silverdale

    Silverdale, Washington, 98383

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Evergreen Hematology and Oncology PS

    Spokane, Washington, 99218

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

  • Mercy Infusion Center - Chippewa

    St Louis, Missouri, 63109

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Saint Louis-Cape Girardeau CCOP

    St Louis, Missouri, 63141

  • Scott and White Memorial Hospital

    Temple, Texas, 76508

  • Cotton O'Neil Cancer Center / Stormont Vail Health

    Topeka, Kansas, 66606

  • University of Kansas Health System Saint Francis Campus

    Topeka, Kansas, 66606

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Upper Valley Medical Center

    Troy, Ohio, 45373

  • South Georgia Medical Center/Pearlman Cancer Center

    Valdosta, Georgia, 31602

  • PeaceHealth Southwest Medical Center

    Vancouver, Washington, 98664

  • Henry Ford Health Warren Hospital

    Warren, Michigan, 48093

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Wenatchee Valley Hospital and Clinics

    Wenatchee, Washington, 98801

  • Associates In Womens Health

    Wichita, Kansas, 67208

  • Cancer Center of Kansas-Wichita Medical Arts Tower

    Wichita, Kansas, 67208

  • Ascension Via Christi Hospitals Wichita

    Wichita, Kansas, 67214

  • Cancer Center of Kansas - Wichita

    Wichita, Kansas, 67214

  • Wichita NCI Community Oncology Research Program

    Wichita, Kansas, 67214

  • Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center

    Wilmington, Ohio, 45177

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Southeast Clinical Oncology Research Consortium NCORP

    Winston-Salem, North Carolina, 27104

  • University of Michigan Health - West

    Wyoming, Michigan, 49519

  • Greene Memorial Hospital

    Xenia, Ohio, 45385

Other trials in United States

About this study

Official title: A Phase II Trial of SCH 727965 (NSC 747135) in Patients With Stage IV Melanoma

This phase II trial is studying the side effects and how well dinaciclib works in treating patients with stage IV melanoma. Dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the 1-year overall survival rate in patients with stage IV melanoma treated with dinaciclib.

SECONDARY OBJECTIVES:

  1. To assess the 6-month progression-free survival rate in these patients. II. To evaluate the response rate (confirmed and unconfirmed complete and partial responses) in the subset of patients with measurable disease.

III. To assess the safety and tolerability of dinaciclib given to patients with stage IV melanoma.

OUTLINE: This is a multicenter study.

Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

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

Being tested
Dinaciclib
Medical subject headings
Melanoma

What participants receive

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

  • DinaciclibDrug

    Also called CDK Inhibitor SCH 727965, MK 7965, MK-7965, MK7965

    Given IV

Study groups in NCT00937937
Study groupRoleWhat they receive
Arm IExperimentalPatients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Dinaciclib

What is being measured

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

  1. Overall Survival

    From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

    Measured: Weekly, up to 3 years

Secondary outcomes (3)

  1. Progression-free Survival Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The duration from the date of randomization to the date of first documentation of progressive disease, symptomatic deterioration, or death dure to any cause.

    Measured: Disease assessment was performed every 6 weeks, up to 3 years.

  2. Response Rate (Confirmed and Unconfirmed Complete and Partial Responses) Assessed by RECIST

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: Disease assessments for response were performed every 6 weeks, up to 3 years

  3. Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

    Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. The outcome measure here is different from Serious Adverse Event, whose definition could be more strict and specific. The number of patients who suffers the certain adverse event listed here could be larger than the number listed in following serious adverse event.

    Measured: Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.

Timeline

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

  1. First posted13 Jul 2009 (estimated)
  2. Study start1 Jul 2009
  3. Primary completion22 Oct 2013
  4. Study completion19 Mar 2027 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00937937
Sponsor's protocol ID
NCI-2011-01935
Other IDs
NCI-2011-01935, SWOG-S0826, CDR0000647155, S0826, S0826, U10CA032102
Status last verified
Sep 2026
First submitted
10 Jul 2009
Last updated
14 Sep 2026

Publications

  • Lao CD, Moon J, Ma VT, Fruehauf JP, Flaherty LE, Bury MJ, Martin WG, Gross H, Akerley W, Hopkins JO, Patel SP, Sondak VK, Ribas A. Southwest Oncology Group S0826: A phase 2 trial of SCH 727965 (NSC 727135, dinaciclib) in patients with stage IV melanoma. Cancer. 2025 Jan 1;131(1):e35587. doi: 10.1002/cncr.35587. Epub 2024 Sep 29.

    PubMed 39342463

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dinaciclib in people with Acral Lentiginous Melanoma and Cutaneous Nodular Melanoma, run by National Cancer Institute (NCI) at 190 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?

The sponsor lists 30 inclusion and 0 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 190 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 22 Jul 2016). 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?

Overall Survival (time frame: Weekly, up to 3 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 NCT00937937, which also lists 1 linked publication.

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 14 Sep 2026.

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