search
Back to results

Trametinib 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
Second Affiliated Hospital of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 15, 2021
Last Updated
February 26, 2023
Sponsor
Second Affiliated Hospital of Guangzhou Medical University
search

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

We'll reach out to this number within 24 hrs