MEK162 for Patients With RAS/RAF/MEK Activated Tumors

NCT01885195

Last updated date
Study Location
University of South Alabama / Mitchell Cancer Institute Univ South Alabama
Mobile, Alabama, 36688, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Solid Tumor and Hematologic Malignancies
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-100 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patient has a confirmed diagnosis of a select solid tumor (except for primary diagnosis of pancreatic cancer, biliary cancer, colorectal cancer, low grade serous ovarian cancer, melanoma) or hematologic malignancy (except for primary diagnosis of chronic myelomonocytic leukemia).

- Patients must be pre-identified as having a tumor with a mutation in RAF, RAS, NF1 or MEK at a CLIA certified laboratory

- Patient must have received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.

- Patient must have progressive and measurable disease as per RECIST 1.1. or other appropriate hematological guidelines.

- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

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


- Patient has received prior treatment with MEK162.


- Patients with primary CNS tumor or CNS tumor involvement


- History of retinal degenerative disease


- History or current evidence of central serous retinopathy (CSR) or retinal vein
occlusion (RVO)


- Any ophthalmopathy visible at screening that would be considered a risk factor for CSR
or RVO by the ophthalmologist


- Patients who have neuromuscular disorders that are associated with elevated CK

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Solid Tumor and Hematologic MalignanciesMEK162 for Patients With RAS/RAF/MEK Activated Tumors
NCT01885195
  1. Mobile, Alabama
  2. Anchorage, Alaska
  3. Phoenix, Arizona
  4. Phoenix, Arizona
  5. Sedona, Arizona
  6. Fayetteville, Arkansas
  7. Pismo Beach, California
  8. Sacramento, California
  9. Boulder, Colorado
  10. New Haven, Connecticut
  11. Norwalk, Connecticut
  12. Norwich, Connecticut
  13. Stamford, Connecticut
  14. Fort Myers, Florida
  15. Hollywood, Florida
  16. Jacksonville, Florida
  17. Miami Beach, Florida
  18. Ocala, Florida
  19. Ocoee, Florida
  20. Athens, Georgia
  21. Chicago, Illinois
  22. Park Ridge, Illinois
  23. Peoria, Illinois
  24. Indianapolis, Indiana
  25. Iowa City, Iowa
  26. Rockville, Maryland
  27. Grand Rapids, Michigan
  28. Coon Rapids, Minnesota
  29. Kansas City, Missouri
  30. Saint Louis, Missouri
  31. Kalispell, Montana
  32. Las Vegas, Nevada
  33. New Brunswick, New Jersey
  34. Albuquerque, New Mexico
  35. Troy, New York
  36. Chapel Hill, North Carolina
  37. Durham, North Carolina
  38. Fargo, North Dakota
  39. Cleveland, Ohio
  40. Columbus, Ohio
  41. Bend, Oregon
  42. Eugene, Oregon
  43. Portland, Oregon
  44. Portland, Oregon
  45. Bethlehem, Pennsylvania
  46. Natrona Heights, Pennsylvania
  47. Willow Grove, Pennsylvania
  48. Chattanooga, Tennessee
  49. Memphis, Tennessee
  50. Nashville, Tennessee
  51. Dallas, Texas
  52. Dallas, Texas
  53. Dallas, Texas
  54. Dallas, Texas
  55. Dallas, Texas
  56. Houston, Texas
  57. Houston, Texas
  58. San Antonio, Texas
  59. Tyler, Texas
  60. Webster, Texas
  61. Murray, Utah
  62. Fairfax, Virginia
  63. Reston, Virginia
  64. Kennewick, Washington
  65. Lacey, Washington
  66. Tacoma, Washington
  67. Tacoma, Washington
  68. Milwaukee, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE MEK162 for Patients With RAS/RAF/MEK Activated Tumors
Official Title  ICMJE Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors: Module 3 - MEK162 for Patients With RAS/RAF/MEK Activated Tumors
Brief Summary The purpose of this signal seeking study is to determine whether treatment with MEK162 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study
Detailed Description

This is a phase II, open label study to determine the efficacy and safety of treatment with MEK162 in patients with a diagnosis of select solid tumors or hematological malignancies that have been pre-identified (prior to study consent) to have activations of the RAS/RAF/MEK pathway and whose disease has progressed on or after standard treatment.

Genomic profiling is becoming more accessible to patients and their physicians. This is a signal-seeking study to match patients with mutations in RAF, RAS, NF1 or MEK to the ATP-noncompetitive MEK 1/2 inhibitor, MEK162. Pre-identification of these mutations or activations in the pathway will be performed locally at a CLIA certified laboratory prior to screening for participation on the trial.

Once the patient has been identified, treating physicians who are qualified investigators may contact Novartis to consider enrollment in this study. For the purpose of this study, genomic profiling is not considered part of screening. Informed consent must be signed before any screening activities take place. Once eligibility (screening criteria met) has been confirmed by Novartis, the patient will initiate therapy with single agent MEK162. The patient may not receive any additional anti-cancer therapy during treatment with MEK162.

Patients will continue to receive study treatment until disease progression (assessed by RECIST 1.1 or appropriate hematologic response criteria), unacceptable toxicity, death or discontinuation from study treatment for any other reason (e.g., withdrawal of consent, start of a new anti-neoplastic therapy or at the discretion of the investigator), otherwise known as End of Treatment. All patients who discontinue from study treatment due to disease progression must have their progression clearly documented.

Disease assessment (per RECIST 1.1 or appropriate hematological response criteria) will be performed every 8 weeks (±4 days) after first dose of study drug (Day 1 of every odd cycle), until disease progression or end of treatment, whichever occurs first. The frequency of disease assessment may be reduced to every 12 weeks for patients who have at least 4 post-baseline disease assessments and are clinically stable (except AML and MM patients). Scans will be assessed locally by the investigator. After discontinuation of treatment, patients, regardless of reason for treatment discontinuation, will be followed for safety for 30 days after the last dose.

All patients will be followed for survival status every 3 months for 2 years after the last patient has enrolled in the study regardless of treatment discontinuation reason (except if consent is withdrawn or patient is lost to follow-up.)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor and Hematologic Malignancies
Intervention  ICMJE Drug: MEK162
MEK162 will be dosed on a flat scale of 45 mg twice daily on a continuous dosing schedule.
Study Arms  ICMJE Experimental: MEK162
MEK162 will be dosed on a flat scale of 45 mg twice daily on a continuous dosing schedule.
Intervention: Drug: MEK162
Publications * Burkart J, Owen D, Shah MH, Abdel-Misih SRZ, Roychowdhury S, Wesolowski R, Haraldsdottir S, Reeser JW, Samorodnitsky E, Smith A, Konda B. Targeting BRAF Mutations in High-Grade Neuroendocrine Carcinoma of the Colon. J Natl Compr Canc Netw. 2018 Sep;16(9):1035-1040. doi: 10.6004/jnccn.2018.7043.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: February 21, 2015)
110
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2013)
70
Actual Study Completion Date  ICMJE April 11, 2017
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient has a confirmed diagnosis of a select solid tumor (except for primary diagnosis of pancreatic cancer, biliary cancer, colorectal cancer, low grade serous ovarian cancer, melanoma) or hematologic malignancy (except for primary diagnosis of chronic myelomonocytic leukemia).
  • Patients must be pre-identified as having a tumor with a mutation in RAF, RAS, NF1 or MEK at a CLIA certified laboratory
  • Patient must have received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.
  • Patient must have progressive and measurable disease as per RECIST 1.1. or other appropriate hematological guidelines.
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ? 1

Exclusion Criteria:

  • Patient has received prior treatment with MEK162.
  • Patients with primary CNS tumor or CNS tumor involvement
  • History of retinal degenerative disease
  • History or current evidence of central serous retinopathy (CSR) or retinal vein occlusion (RVO)
  • Any ophthalmopathy visible at screening that would be considered a risk factor for CSR or RVO by the ophthalmologist
  • Patients who have neuromuscular disorders that are associated with elevated CK
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 100 Years   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01885195
Other Study ID Numbers  ICMJE CMEK162AUS11
C4211007 ( Other Identifier: Pfizer )
Has Data Monitoring Committee No
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 October 2020

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