MEK Inhibitor AZD6244 in Treating Patients With Stage III or Stage IV Melanoma

NCT00866177 | Completed Phase 2 Results

• 7 other identifiers: NCI-2009-01164MSKCC-09003CDR000063766909-0038252N01CM62206P30CA008748
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well MEK inhibitor AZD6244 works in treating patients with stage III or stage IV melanoma. MEK inhibitor AZD6244 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

Recurrent Melanoma; Stage III Skin Melanoma; Stage IV Skin Melanoma

Outcome Measures

Primary Outcomes (1)

• Anti-tumor Response Defined as Either a CR, PR, or SD as Defined by RECIST

  Anti-tumor response defined as either a Complete Response, Partial Response, or Stable Disease as defined by RECIST

  Up to 4 weeks

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker Analysis; Drug: Selumetinib

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I

Selumetinib DRUG

Given orally

Also known as: ARRY-142886, AZD6244, MEK Inhibitor AZD6244

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed melanoma
• Stage IV or stage III disease not potentially curable with surgery
• Documented tumor progression
• Must have a V600E or V600K BRAF-mutated tumor, or a NRAS mutation at condons 12, 13, or 61
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
• Must have tumor tissue (block or unstained slides) available for IHC studies
• No primary uveal or mucosal melanoma
• No active or untreated brain metastases
• Treated brain metastases allowed provided they have been stable for ≥ 3 months
• ECOG performance status 0-1
• Life expectancy \> 3 months
• WBC ≥ 3,000/mcL
• Absolute neutrophil count ≥ 1,500/mcL
• Platelet count ≥ 100,000/mcL
• Hemoglobin ≥ 9.0 g/dL (no requirement for transfusions within the past 2 weeks)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

AZD 6244

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Paul Chapman
• Organization: Memorial Sloan Kettering Cancer Center

chapmanp@mskcc.org

646-888-4162

Study Officials

• Paul Chapman

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: March 19, 2009
• First Posted: March 20, 2009
• Study Start: March 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: August 11, 2015
• Results First Posted: August 11, 2015

Record last verified: 2013-06

Locations

US (1)