Back to resultsTrametinib Combined With Everolimus and Lenvatinib for Recurrent/Refractory Advanced Solid Tumors
Primary Purpose
Solid Tumor, Adult, Hepatocellular Carcinoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Combination of three inhibitors Trametinib, Everolimus and Lenvatinib
Sponsored by
About this trial
This is an interventional treatment trial for Solid Tumor, Adult focused on measuring Hepatocellular Carcinoma;Lung Cancer, Trametinib, Everolimus, Lenvatinib
Eligibility Criteria
Inclusion Criteria:
- Recurrent/Refractory advanced solid tumors
- Age between 18 and 85 years
- Expected life expectancy is greater than three months
Exclusion Criteria:
- Benign tumor
- Life expectancy is less than three months
- Serious medical commodities
- others
Sites / Locations
- The Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Combination treatment of 3 inhibitors
Arm Description
Oral administration of 3 signaling pathways inhibitors: Mek inhibitor Trametinib, mTOR inhibitor Everolimus, and angiogenesis inhibitor Lenvatinib on refractory advanced solid tumors.
Outcomes
Primary Outcome Measures
Assessing Incidence of Treatment-Emergent Adverse Events during the treatment and various responses to the treatment.
Secondary Outcome Measures
Assessing progress free survival
Assessing overall survival
Assessing overall time to survival.
Full Information
NCT ID
NCT04803318
First Posted
March 15, 2021
Last Updated
February 26, 2023
Sponsor
Second Affiliated Hospital of Guangzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04803318
Brief Title
Trametinib Combined With Everolimus and Lenvatinib for Recurrent/Refractory Advanced Solid Tumors
Official Title
Trametinib Combined With Everolimus and Lenvatinib in the Treatment of Recurrent/Refractory Advanced Solid Tumors: a Phase II Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Guangzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To study the clinical effect of Trametinib combined with Everolimus and Lenvatinib in the treatment of Recurrent/Refractory advanced solid tumors.
Detailed Description
The tumor diameter was measured and the efficacy was evaluated after treatment with Trametinib combined with Everolimus and Lenvatinib.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Adult, Hepatocellular Carcinoma
Keywords
Hepatocellular Carcinoma;Lung Cancer, Trametinib, Everolimus, Lenvatinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
To treat recurrent or refractory advanced solid tumors with multiple targeting drugs that inhibit several critical signaling pathways in cancer cells.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Combination treatment of 3 inhibitors
Arm Type
Experimental
Arm Description
Oral administration of 3 signaling pathways inhibitors: Mek inhibitor Trametinib, mTOR inhibitor Everolimus, and angiogenesis inhibitor Lenvatinib on refractory advanced solid tumors.
Intervention Type
Drug
Intervention Name(s)
Combination of three inhibitors Trametinib, Everolimus and Lenvatinib
Other Intervention Name(s)
Combination of 3 signaling pathway inhibitors specific to MEK, mTOR, and angiogenesis.
Intervention Description
Oral administration of three inhibitors including Trametinib, Everolimus and Lenvatinib.
Primary Outcome Measure Information:
Title
Assessing Incidence of Treatment-Emergent Adverse Events during the treatment and various responses to the treatment.
Time Frame
up to 36 months
Secondary Outcome Measure Information:
Title
Assessing progress free survival
Time Frame
48 months
Title
Assessing overall survival
Description
Assessing overall time to survival.
Time Frame
48 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recurrent/Refractory advanced solid tumors
Age between 18 and 85 years
Expected life expectancy is greater than three months
Exclusion Criteria:
Benign tumor
Life expectancy is less than three months
Serious medical commodities
others
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenfeng Zhang, MD, PhD
Phone
+862039195966
Email
zhangzhf@gzhmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Bingjia He, MD
Phone
+862039195966
Email
zhangzhf@gzhmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenfeng Zhang, MD, PhD
Organizational Affiliation
Second Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenfeng Zhang, MD,PhD
Phone
+86-020-39195966
Email
zhangzhf@gzhmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Bingjia He, MD
Phone
+86-14748877800
Email
464677938@qq.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Trametinib Combined With Everolimus and Lenvatinib for Recurrent/Refractory Advanced Solid Tumors
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