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Trametinib Combined With Everolimus and Lenvatinib for Recurrent/Refractory Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04803318
Recruitment Status : Recruiting
First Posted : March 17, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital of Guangzhou Medical University

Brief Summary:
To study the clinical effect of Trametinib combined with Everolimus and Lenvatinib in the treatment of Recurrent/Refractory advanced solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Hepatocellular Carcinoma Drug: Combination of three inhibitors Trametinib, Everolimus and Lenvatinib Phase 2

Detailed Description:
The tumor diameter was measured and the efficacy was evaluated after treatment with Trametinib combined with Everolimus and Lenvatinib.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Trametinib Combined With Everolimus and Lenvatinib in the Treatment of Recurrent/Refractory Advanced Solid Tumors: a Phase II Clinical Trial
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Combination treatment of 3 inhibitors
Oral administration of 3 signaling pathways inhibitors: Mek inhibitor Trametinib, mTOR inhibitor Everolimus, and angiogenesis inhibitor Lenvatinib on refractory advanced solid tumors.
Drug: Combination of three inhibitors Trametinib, Everolimus and Lenvatinib
Oral administration of three inhibitors including Trametinib, Everolimus and Lenvatinib.
Other Name: Combination of 3 signaling pathway inhibitors specific to MEK, mTOR, and angiogenesis.




Primary Outcome Measures :
  1. Assessing Incidence of Treatment-Emergent Adverse Events during the treatment and various responses to the treatment. [ Time Frame: up to 36 months ]

Secondary Outcome Measures :
  1. Assessing progress free survival [ Time Frame: 48 months ]
  2. Assessing overall survival [ Time Frame: 48 months ]
    Assessing overall time to survival.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04803318


Contacts
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Contact: Zhenfeng Zhang, MD, PhD +862039195966 zhangzhf@gzhmu.edu.cn
Contact: Bingjia He, MD +862039195966 zhangzhf@gzhmu.edu.cn

Locations
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China, Guangdong
The Second Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510260
Contact: Zhenfeng Zhang, MD,PhD    +86-020-39195966    zhangzhf@gzhmu.edu.cn   
Contact: Bingjia He, MD    +86-14748877800    464677938@qq.com   
Sponsors and Collaborators
Second Affiliated Hospital of Guangzhou Medical University
Investigators
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Principal Investigator: Zhenfeng Zhang, MD, PhD Second Affiliated Hospital of Guangzhou Medical University
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Responsible Party: Second Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT04803318    
Other Study ID Numbers: Targeting pathways
First Posted: March 17, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Second Affiliated Hospital of Guangzhou Medical University:
Hepatocellular Carcinoma;Lung Cancer
Trametinib
Everolimus
Lenvatinib
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Everolimus
Lenvatinib
Trametinib
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action