LGX818 for Patients With BRAFV600 Mutated Tumors

NCT01981187

Last updated date
Study Location
Alabama Oncology St. Vincent's Birmingham
Birmingham, Alabama, 35211, 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, Hematologic Malignancies
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

- Patient has a confirmed diagnosis of a select solid tumor (except with a primary diagnosis of melanoma and colorectal cancer (CRC)) or hematologic malignancies and is in need of treatment because of progression or relapse.

- Patient's tumor has been evaluated and pre-identified as having a tumor with a BRAFV600 mutation 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 per RECIST 1.1. or other appropriate hematological response criteria.

- 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 LGX818.


- Patients with Central Nerve System (CNS) metastasis or leptomeningeal carcinomatosis.


- Patient has received chemotherapy or other anticancer therapy ≤ 4 weeks (6 weeks for
nitrosourea, antibodies or mitomycin-C) prior to starting study drug.


- Patients with acute or chronic pancreatitis.


- Patients with impaired cardiac function or clinically significant cardiac diseases.


- Patients with another primary malignancy within 3 years prior to starting study
treatment, with the exception of adequately treated basal cell carcinoma, squamous
cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the
uterine cervix.

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Solid Tumor, Hematologic MalignanciesLGX818 for Patients With BRAFV600 Mutated Tumors
NCT01981187
  1. Birmingham, Alabama
  2. Fayetteville, Arkansas
  3. New Haven, Connecticut
  4. Norwalk, Connecticut
  5. Fort Myers, Florida
  6. Chicago, Illinois
  7. Las Vegas, Nevada
  8. Zanesville, Ohio
  9. Philadelphia, Pennsylvania
  10. Sioux Falls, South Dakota
  11. Houston, Texas
  12. Salt Lake City, Utah
  13. Winchester, Virginia
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE LGX818 for Patients With BRAFV600 Mutated Tumors
Official Title  ICMJE Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors: Module 4 - LGX818 for Patients With BRAFV600 Mutated Tumors
Brief Summary The purpose of this signal seeking study is to determine whether treatment with LGX818 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study
Detailed Description Not Provided
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
  • Hematologic Malignancies
Intervention  ICMJE Drug: LGX818
LGX818 will be dosed on a flat scale of 300 mg (e.g., 3 x 100 mg capsules) once daily on a continuous dosing cycle. A complete treatment cycle is defined as 28 days. There will be no breaks between dosing cycles.
Study Arms  ICMJE Experimental: LGX818
LGX818 will be dosed on a flat scale of 300 mg (e.g., 3 x 100 mg capsules) once daily on a continuous dosing cycle. A complete treatment cycle is defined as 28 days. There will be no breaks between dosing cycles.
Intervention: Drug: LGX818
Publications * Not Provided

*   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 27, 2015)
12
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2013)
70
Actual Study Completion Date  ICMJE October 13, 2015
Actual Primary Completion Date September 1, 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 with a primary diagnosis of melanoma and colorectal cancer (CRC)) or hematologic malignancies and is in need of treatment because of progression or relapse.
  • Patient's tumor has been evaluated and pre-identified as having a tumor with a BRAFV600 mutation 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 per RECIST 1.1. or other appropriate hematological response criteria.
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ? 1

Exclusion Criteria:

  • Patient has received prior treatment with LGX818.
  • Patients with Central Nerve System (CNS) metastasis or leptomeningeal carcinomatosis.
  • Patient has received chemotherapy or other anticancer therapy ? 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug.
  • Patients with acute or chronic pancreatitis.
  • Patients with impaired cardiac function or clinically significant cardiac diseases.
  • Patients with another primary malignancy within 3 years prior to starting study treatment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01981187
Other Study ID Numbers  ICMJE CLGX818AUS03
C4221021 ( 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 September 2020

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