A Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma

NCT01320085

Last updated date
Study Location
Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, 72703, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
BRAF or NRAS Mutant Metastatic Melanoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Locally advanced or metastatic cutaneous melanoma AJCC Stage IIIB to IV, not potentially curable with surgery

- BRAF or NRAS mutation in tumor tissue

- All patients enrolled should provide sufficient fresh or archival tumor sample at baseline to enable confirmation of BRAF or NRAS mutations and the additional analyses described in the protocol

- Evidence of measurable tumor disease as per RECIST

- WHO performance status of 0-2

- Adequate organ function and laboratory parameters

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- History or evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO)
or any eye condition that would be considered a risk factor for CSR or RVO


- Patients with unstable CNS metastasis


- Prior treatment with a MEK- inhibitor


- Impaired cardiovascular function


- HIV, active Hepatitis B, and/or active Hepatitis C infection


- Pregnant or nursing (lactating) women


- Women of child-bearing potential UNLESS they comply with protocol contraceptive
requirements


Other protocol-defined inclusion/exclusion criteria may apply.

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BRAF or NRAS Mutant Metastatic MelanomaA Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma
NCT01320085
  1. Fayetteville, Arkansas
  2. Tampa, Florida
  3. Portland, Oregon
  4. Bethlehem, Pennsylvania
  5. Greenville, South Carolina
  6. Essen,
  7. Gera,
  8. Kiel,
  9. Muenchen,
  10. Genova, GE
  11. Napoli,
  12. Amsterdam,
  13. Maastricht,
  14. Nijmegen,
  15. Chur,
  16. Zürich,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma
Official Title  ICMJE A Phase II, Open-label Study to Assess the Safety and Efficacy of Oral MEK162 in Adults With Locally Advanced and Unresectable or Metastatic Malignant Cutaneous Melanoma, Harboring BRAFV600 or NRAS Mutations
Brief Summary The study will assess the safety and efficacy of single-agent MEK162 in adult patients with locally advanced and unresectable or metastatic malignant cutaneous melanoma, harboring BRAFV600E or NRAS mutations.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE BRAF or NRAS Mutant Metastatic Melanoma
Intervention  ICMJE Drug: MEK162
Study Arms  ICMJE
  • Experimental: BRAFV600 mutant, 45mg bid MEK162
    BRAFV600 mutant, 45mg bid MEK162
    Intervention: Drug: MEK162
  • Experimental: NRAS mutant, 45mg bid MEK162
    NRAS mutant, 45mg bid MEK162
    Intervention: Drug: MEK162
  • Experimental: BRAFV600 mutant, 60mg bid MEK162
    BRAFV600 mutant, 60mg bid MEK162
    Intervention: Drug: MEK162
Publications * Ascierto PA, Schadendorf D, Berking C, Agarwala SS, van Herpen CM, Queirolo P, Blank CU, Hauschild A, Beck JT, St-Pierre A, Niazi F, Wandel S, Peters M, Zubel A, Dummer R. MEK162 for patients with advanced melanoma harbouring NRAS or Val600 BRAF mutations: a non-randomised, open-label phase 2 study. Lancet Oncol. 2013 Mar;14(3):249-56. doi: 10.1016/S1470-2045(13)70024-X. Epub 2013 Feb 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 5, 2015)
183
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2011)
54
Estimated Study Completion Date  ICMJE June 2020
Actual Primary Completion Date January 7, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Locally advanced or metastatic cutaneous melanoma AJCC Stage IIIB to IV, not potentially curable with surgery
  • BRAF or NRAS mutation in tumor tissue
  • All patients enrolled should provide sufficient fresh or archival tumor sample at baseline to enable confirmation of BRAF or NRAS mutations and the additional analyses described in the protocol
  • Evidence of measurable tumor disease as per RECIST
  • WHO performance status of 0-2
  • Adequate organ function and laboratory parameters

Exclusion Criteria:

  • History or evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or any eye condition that would be considered a risk factor for CSR or RVO
  • Patients with unstable CNS metastasis
  • Prior treatment with a MEK- inhibitor
  • Impaired cardiovascular function
  • HIV, active Hepatitis B, and/or active Hepatitis C infection
  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential UNLESS they comply with protocol contraceptive requirements

Other protocol-defined inclusion/exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Italy,   Netherlands,   Switzerland,   United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT01320085
Other Study ID Numbers  ICMJE CMEK162X2201
2010-023412-13 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP