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

NCT04803318 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ZZ3TKI-011
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumor, Adult; Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma;Lung Cancer; Trametinib; Everolimus; Lenvatinib

Outcome Measures

Primary Outcomes (1)

• Assessing Incidence of Treatment-Emergent Adverse Events during the treatment and various responses to the treatment.

  up to 36 months

Secondary Outcomes (2)

• Assessing progress free survival

  48 months

• Assessing overall survival

  48 months

Study Arms (1)

Combination treatment of 3 inhibitors

EXPERIMENTAL

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

Interventions

Combination of three inhibitors Trametinib, Everolimus and Lenvatinib DRUG

Oral administration of three inhibitors including Trametinib, Everolimus and Lenvatinib.

Also known as: Combination of 3 signaling pathway inhibitors specific to MEK, mTOR, and angiogenesis.

Combination treatment of 3 inhibitors

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recurrent/Refractory advanced solid tumors
• Age between 18 and 85 years
• Expected life expectancy is greater than three months

You may not qualify if:

• Benign tumor
• Life expectancy is less than three months
• Serious medical commodities
• others

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Everolimus; lenvatinib; Angiogenesis

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Zhenfeng Zhang, MD, PhD

  Second Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenfeng Zhang, MD, PhD

CONTACT

+862039195966; zhangzhf@gzhmu.edu.cn

Bingjia He, MD

CONTACT

+862039195966; zhangzhf@gzhmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To treat recurrent or refractory advanced solid tumors with multiple targeting drugs that inhibit several critical signaling pathways in cancer cells.

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 17, 2021
• Study Start: January 1, 2021
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2037
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

CN (1)