NCT01216787

Brief Summary

This pilot phase II trial is studying how well RO4929097 works in treating patients with stage III, or stage IV melanoma that can be removed by surgery. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

Enrollment Period

1.2 years

First QC Date

October 6, 2010

Last Update Submit

January 30, 2013

Conditions

Stage IIIB MelanomaStage IIIC MelanomaStage IV Melanoma

Outcome Measures

Primary Outcomes (1)

  • Molecular effects of notch-signaling inhibition

    All statistics will be descriptive.

    Up to 2 years

Secondary Outcomes (11)

  • Toxicity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

    2 years

  • Response rate (complete or partial response) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Up to 2 years

  • Change in Akt-mediated downstream biomarkers by immunohistochemistry (IHC)

    From baseline to 4 weeks at the time of surgery

  • Change in stem cell subpopulation

    From baseline to 4 weeks at the time of surgery

  • Correlation between patient-specific micro-RNA signatures with response to therapy, recurrence and overall survival

    At baseline and at 4 weeks at the time of surgery

  • +6 more secondary outcomes

Study Arms (1)

Treatment (gamma-secretase inhibitor RO4929097, surgery)

EXPERIMENTAL

Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Within 35-56 days after completion of therapy, patients with stable or responsive disease undergo surgery. Patients may continue RO4929097 for 28 days after surgery in the absence of disease progression or unacceptable toxicity.

Drug: gamma-secretase/Notch signalling pathway inhibitor RO4929097Other: pharmacological studyProcedure: therapeutic conventional surgeryOther: laboratory biomarker analysis

Interventions

gamma-secretase/Notch signalling pathway inhibitor RO4929097DRUG
Also known as: R4733, RO4929097
Treatment (gamma-secretase inhibitor RO4929097, surgery)
pharmacological studyOTHER
Also known as: pharmacological studies
Treatment (gamma-secretase inhibitor RO4929097, surgery)
therapeutic conventional surgeryPROCEDURE
Treatment (gamma-secretase inhibitor RO4929097, surgery)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (gamma-secretase inhibitor RO4929097, surgery)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed melanoma
  • Stage IIIB, IIIC, or IV disease
  • Disease that is deemed resectable by surgical consultation
  • Patients must agree to pretreatment biopsies of their tumor
  • Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques OR as ≥ 10 mm by spiral CT scan
  • Measurable lesions must be deemed resectable
  • Skin metastases must be photographed and measured
  • No non-target disease
  • No known brain metastases
  • Life expectancy \> 3 months
  • ECOG performance status 0-2 (Karnofsky 60-100%)
  • WBC ≥ 3,000/mm³
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 75,000/mm³
  • Hemoglobin \> 10 g/dL
  • +29 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467-2490, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

2,2-dimethyl-N-(6-oxo-6,7-dihydro-5H-dibenzo(b,d)azepin-7-yl)-N'-(2,2,3,3,3-pentafluoropropyl)malonamide

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Anna Pavlick

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

October 6, 2010

First Posted

October 7, 2010

Study Start

September 1, 2010

Primary Completion

November 1, 2011

Last Updated

January 31, 2013

Record last verified: 2013-01

Locations

US(2)