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Acral Lentiginous Malignant MelanomaPhase 2NCT01120275

Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Stage IV Melanoma

A Phase 2 study testing gamma-secretase/Notch signalling pathway inhibitor RO4929097 and laboratory biomarker analysis in people with Acral Lentiginous Malignant Melanoma and Lentigo Maligna Malignant Melanoma, run by National Cancer Institute (NCI) at 178 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This phase II trial is studying how well gamma-secretase/Notch signalling pathway inhibitor RO4929097 works in treating patients with stage IV melanoma. Gamma-secretase/Notch signalling pathway inhibitor RO4929097 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?
gamma-secretase/Notch signalling pathway inhibitor RO4929097 and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
178 sitesUnited States
Study dates
Oct 2010to Aug 2015
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

  • Patients must have histologically confirmed melanoma of cutaneous or unknown origin (ocular primary and mucosal primary excluded); patients must have Stage IV disease
  • All patients must undergo a computed tomography (CT) or magnetic resonance imaging (MRI) of the brain within 42 days prior to registration that is negative for brain metastases; patients with a history of brain metastases are ineligible
  • Patients must have measurable disease; all measurable lesions must be assessed (by physical examination, CT, or MRI scan) within 28 days prior to registration; tests to assess non-measurable disease must be performed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria In Solid Tumors [RECIST] 1.1); the CT from a combined positron emission tomography (PET)/CT must not be used to document measurable disease unless it is of diagnostic quality
  • Sites must offer all patients participation in translational medicine studies and banking of paraffin embedded tissue and whole blood
  • Patients must not have received any prior systemic therapy for Stage IV disease except for noncytotoxic biologic agents (e.g., vaccines, cytokines, cell therapies that do not require cytotoxic agents); patients may have received prior treatment with up to two prior biological therapies - no cytotoxics or kinase inhibitors - for advanced disease
  • Patients may have had prior adjuvant immunotherapy with biological response modifiers (examples include but are not limited to interferon, vaccines, GM-CSF, and CTLA-4 blocking antibodies); prior adjuvant immunotherapy must have been completed at least 28 days prior to registration
Show all 34Show fewer
  • Adjuvant therapy containing cytotoxic agents is allowed if completed >= 180 days prior to registration
  • Patients may have received prior radiation therapy; any side effects the patients had due to prior radiation therapy must have resolved to =< Grade 1 prior to registration; prior radiation therapy must have completed at least 28 days prior to registration
  • Patients must have Zubrod performance status of 0-1
  • Leukocytes >= 3,000/mcL
  • Absolute neutrophil count (ANC) >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Hemoglobin >= 9 g/dL
  • Total bilirubin =< institutional upper limit of normal (IULN)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 x IULN
  • Serum creatinine =< IULN OR measured or calculated creatinine clearance >= 60 mL/min
  • Patients must have the following serum electrolytes within the institutional ranges of normal: potassium, sodium, magnesium, phosphorous, chloride and calcium (corrected for serum albumin); these tests must be performed within 28 days prior to registration; patient must not require parenteral replacement therapy
  • Patients must not have a history of allergic reaction attributed to compounds of similar chemical or biologic composition to RO4929097
  • Patients must be able to swallow tablets
  • Patients must not have malabsorption syndrome or other condition that would interfere with intestinal absorption of the agent
  • Patients taking medications with narrow therapeutic indices that are metabolized by cytochrome P450 (CYP450), including warfarin sodium (Coumadin), are ineligible
  • Patients must not be taking strong inducers or strong inhibitors of CYP3A4 at the time of registration
  • Patients must not be known to be serologically positive for Hepatitis A, B, or C, or have a history of liver disease, other forms of hepatitis, or cirrhosis
  • Patients must have an ECG within 28 days prior to registration. Patients must not have a QTcF > 450 msec (males) or QTcF > 470 msec (females)
  • Patients must not have symptomatic congestive heart failure or unstable angina pectoris
  • Patients with a history of torsades de pointes or any significant cardiac arrhythmia (except asymptomatic unifocal ventricular premature beats or supraventricular tachycardia easily controlled with oral medications) are excluded; any patient requiring or expected to require antiarrhythmics or other therapy known to prolong QTc is also excluded
  • No other prior malignancy is allowed except for the following: 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 five years
  • Women of childbearing potential must have a negative pregnancy test within 14 days prior to registration (the type of pregnancy test used is at the discretion of the registering institution); female patients of childbearing potential include the following:
  • Patients with regular menses
  • Patients, after menarche with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding
  • Women who have had tubal ligation
  • Women must not be nursing due to possible harm to a nursing infant from the treatment regimen
  • All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base

Who cannot join

None listed.

Trial locations and contacts

178 sites in 1 country.

178 sites in 1 country

United States178 sites

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Saint Anthony's Health

    Alton, Illinois, 62002

  • Cancer Care Center at Island Hospital

    Anacortes, Washington, 98221

  • AnMed Health Hospital

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • Michigan Cancer Research Consortium Community Clinical Oncology Program

    Ann Arbor, Michigan, 48106

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Mission Hospital-Memorial Campus

    Asheville, North Carolina, 28801

  • University of Colorado Cancer Center - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • Saint Francis Hospital and Health Centers

    Beech Grove, Indiana, 46107

  • Mary Rutan Hospital

    Bellefontaine, Ohio, 43311

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Spectrum Health Big Rapids Hospital

    Big Rapids, Michigan, 49307

  • Montana Cancer Consortium CCOP

    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

  • Central Care Cancer Center-Carrie J Babb Cancer Center

    Bolivar, Missouri, 65613

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • CoxHealth Cancer Center

    Branson, Missouri, 65616

  • Harrison HealthPartners Hematology and Oncology-Bremerton

    Bremerton, Washington, 98310

  • Highline Medical Center-Main Campus

    Burien, Washington, 98166

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • University of Chicago

    Chicago, Illinois, 60637

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Columbus CCOP

    Columbus, Ohio, 43215

  • Grant Medical Center

    Columbus, Ohio, 43215

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Genesis Medical Center - East Campus

    Davenport, Iowa, 52803

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Health Center

    Dayton, Ohio, 45415

  • Dayton CCOP

    Dayton, Ohio, 45420

  • Oakwood Hospital

    Dearborn, Michigan, 48124

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Denver Veterans Administration Medical Center

    Denver, Colorado, 80220

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Hurley Medical Center

    Flint, Michigan, 48502

  • 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

  • Saint Edward Mercy Medical Center

    Fort Smith, Arkansas, 72903

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • 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

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Hays Medical Center

    Hays, Kansas, 67601

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Oncare Hawaii Inc-POB II

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • University of Hawaii

    Honolulu, Hawaii, 96813

  • Oncare Hawaii Inc-Kuakini

    Honolulu, Hawaii, 96817

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Promise Regional Medical Center-Hutchinson

    Hutchinson, Kansas, 65702

  • Allegiance Health

    Jackson, Michigan, 49201

  • Castle Medical Center

    Kailua, Hawaii, 96734

  • Glacier Oncology PLLC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Truman Medical Center

    Kansas City, Missouri, 64108

  • Saint Luke's Cancer Institute

    Kansas City, Missouri, 64111

  • 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

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Columbia Basin Hematology and Oncology PLLC

    Kennewick, Washington, 99336

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Wellmont Holston Valley Hospital and Medical Center

    Kingsport, Tennessee, 37660

  • Evergreen Hospital Medical Center

    Kirkland, Washington, 98033

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • 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

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Liberty Hospital

    Liberty, Missouri, 64068

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Saint Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Memorial Hospital Of Martinsville

    Martinsville, Virginia, 24115

  • Fremont - Rideout Cancer Center

    Marysville, California, 95901

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Montana Cancer Specialists

    Missoula, Montana, 59802

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Providence Hospital

    Mobile, Alabama, 36608

  • Louisiana State University Sciences Center- Monroe

    Monroe, Louisiana, 71210

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • Skagit Valley Hospital

    Mount Vernon, Washington, 98274

  • Mercy Health Mercy Campus

    Muskegon, Michigan, 49444

  • Licking Memorial Hospital

    Newark, Ohio, 43055

  • University of California Medical Center At Irvine-Orange Campus

    Orange, California, 92868

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Saint Luke's South Hospital

    Overland Park, Kansas, 66213

  • Via Christi Hospital-Pittsburg

    Pittsburg, Kansas, 66762

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Saint Joseph Mercy Port Huron

    Port Huron, Michigan, 48060

  • Adventist Medical Center

    Portland, Oregon, 97216

  • SWOG

    Portland, Oregon, 97239

  • Harrison HealthPartners Hematology and Oncology-Poulsbo

    Poulsbo, Washington, 98370

  • Kansas City CCOP

    Prairie Village, Kansas, 66208

  • Reid Hospital and Health Care Services

    Richmond, Indiana, 47374

  • University of Rochester

    Rochester, New York, 14642

  • William Beaumont Hospital-Royal Oak

    Royal Oak, Michigan, 48073

  • University of California at Davis Cancer Center

    Sacramento, California, 95817

  • Saint Mary's of Michigan

    Saginaw, Michigan, 48601

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Salina Regional Health Center

    Salina, Kansas, 67401

  • Virginia Mason CCOP

    Seattle, Washington, 98101

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Minor and James Medical PLLC

    Seattle, Washington, 98104

  • Pacific Medical Center-First Hill

    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

  • Shawnee Mission Medical Center

    Shawnee Mission, Kansas, 66204

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Highland Clinic

    Shreveport, Louisiana, 71105

  • Louisiana State University Health Sciences Center Shreveport

    Shreveport, Louisiana, 71130

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Upstate Carolina CCOP

    Spartanburg, South Carolina, 29303

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Evergreen Hematology and Oncology PS

    Spokane, Washington, 99218

  • Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield

    Springfield, Missouri, 65802

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Springfield Regional Medical Center

    Springfield, Ohio, 45505

  • Saint Louis Cancer and Breast Institute-South City

    St Louis, Missouri, 63109

  • Saint John's Mercy Medical Center

    St Louis, Missouri, 63141

  • Saint Louis-Cape Girardeau CCOP

    St Louis, Missouri, 63141

  • Iredell Memorial Hospital

    Statesville, North Carolina, 28677

  • Saint Francis Hospital and Medical Center - Topeka

    Topeka, Kansas, 66606

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Upper Valley Medical Center

    Troy, Ohio, 45373

  • Tahoe Forest Cancer Center

    Truckee, California, 96161

  • University of Arizona Health Sciences Center

    Tucson, Arizona, 85724

  • Maui Memorial Medical Center

    Wailuku, Hawaii, 96793

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801

  • Saint Ann's Hospital

    Westerville, Ohio, 43081

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Clinton Memorial Hospital

    Wilmington, Ohio, 45177

  • Metro Health Hospital

    Wyoming, Michigan, 49519

  • Greene Memorial Hospital

    Xenia, Ohio, 45385

  • Genesis HealthCare System

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: Phase II Study of RO4929097 (NSC-749225) in Advanced Melanoma

This phase II trial is studying how well gamma-secretase/Notch signalling pathway inhibitor RO4929097 works in treating patients with stage IV melanoma. Gamma-secretase/Notch signalling pathway inhibitor RO4929097 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 six-month progression-free survival and one-year overall survival probability in Stage IV melanoma patients treated with RO4929097 (gamma-secretase/Notch signalling pathway inhibitor RO4929097).

SECONDARY OBJECTIVES:

  1. To investigate in a preliminary manner the relationship between Notch activation status and gene expression profile of tumor and clinical outcomes from patients in this study.

II. To study the effects of the investigational therapy on T cell function, which will provide a basis for subsequent trials combining Notch blockade with immunomodulatory therapy for advanced melanoma.

III. To assess the response rate (confirmed and unconfirmed complete and partial responses).

IV. To assess toxicity.

OUTLINE: This is a multicenter study.

Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 orally (PO) on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Some patients undergo blood collection at baseline and during study for analysis of T-cell function by flow cytometry and ELISA. Tumor tissue samples from biopsy or surgery are also analyzed for Notch activation by IHC and qRT-PCR.

After completion of study therapy, patients are followed up every 3 months for 1 year and then every 6 months for 2 years.

Being tested
gamma-secretase/Notch signalling pathway inhibitor RO4929097, laboratory biomarker analysis
Medical subject headings
Melanoma

What participants receive

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

  • gamma-secretase/Notch signalling pathway inhibitor RO4929097Drug

    Also called R4733, RO4929097

    Given PO

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT01120275
Study groupRoleWhat they receive
Treatment (gamma-secretase inhibitor RO4929097)ExperimentalPatients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: gamma-secretase/Notch signalling pathway inhibitor RO4929097; Other: laboratory biomarker analysis

What is being measured

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

  1. Progression-free Survival According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause.

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

  2. 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 (2)

  1. Percentage of Participants With Confirmed and Unconfirmed Complete or Partial Response

    Complete disappearance of all measurable and non-measurable disease, or greater than or equal to 30% decrease under baseline of the sum of the longest diameters of all target measurable lesions.

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

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

    Adverse Events (AEs) are reported by CTCAE version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.

    Measured: Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, 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 posted10 May 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionMay 2013
  4. Study completionAug 2015

Why it stopped: Administratively complete.

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
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01120275
Sponsor's protocol ID
NCI-2011-02040
Other IDs
NCI-2011-02040, SWOG-S0933, CDR0000671815, S0933, S0933, U10CA032102
Status last verified
May 2016
First submitted
7 May 2010
Last updated
14 Jun 2016

Publications

  • Lee SM, Moon J, Redman BG, Chidiac T, Flaherty LE, Zha Y, Othus M, Ribas A, Sondak VK, Gajewski TF, Margolin KA. Phase 2 study of RO4929097, a gamma-secretase inhibitor, in metastatic melanoma: SWOG 0933. Cancer. 2015 Feb 1;121(3):432-440. doi: 10.1002/cncr.29055. Epub 2014 Sep 23.

    PubMed 25250858

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gamma-secretase/Notch signalling pathway inhibitor RO4929097 and laboratory biomarker analysis in people with Acral Lentiginous Malignant Melanoma and Lentigo Maligna Malignant Melanoma, run by National Cancer Institute (NCI) at 178 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 34 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: stopped early, as of the sponsor's last update on 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 178 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 14 Jun 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?

Progression-free Survival According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (time frame: Disease assessments were performed every 6 weeks, up to 3 years.). 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 NCT01120275, 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 Jun 2016.

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