Solid Tumor, AdultPhase 2NCT04803318
Trametinib Combined With Everolimus and Lenvatinib for Recurrent/Refractory Advanced Solid Tumors
A Phase 2 study testing Combination of three inhibitors Trametinib, Everolimus and Lenvatinib in people with Solid Tumor, Adult and Hepatocellular Carcinoma, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
To study the clinical effect of Trametinib combined with Everolimus and Lenvatinib in the treatment of Recurrent/Refractory advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Solid Tumor, Adult, Hepatocellular Carcinoma
- What is being tested?
- Combination of three inhibitors Trametinib, Everolimus and Lenvatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Jan 2037
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent/Refractory advanced solid tumors
- Age between 18 and 85 years
- Expected life expectancy is greater than three months
Who cannot join
- Benign tumor
- Life expectancy is less than three months
- Serious medical commodities
- others
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
Zhenfeng Zhang, MD,PhD, +86-020-39195966, zhangzhf@gzhmu.edu.cn
Bingjia He, MD, +86-14748877800, 464677938@qq.com
About this study
Official title: Trametinib Combined With Everolimus and Lenvatinib in the Treatment of Recurrent/Refractory Advanced Solid Tumors: a Phase II Clinical Trial
To study the clinical effect of Trametinib combined with Everolimus and Lenvatinib in the treatment of Recurrent/Refractory advanced solid tumors.
Read the detailed description
The tumor diameter was measured and the efficacy was evaluated after treatment with Trametinib combined with Everolimus and Lenvatinib.
- Conditions
- Solid Tumor, Adult, Hepatocellular Carcinoma
- Being tested
- Combination of three inhibitors Trametinib, Everolimus and Lenvatinib
- Keywords
- Hepatocellular Carcinoma;Lung Cancer, Trametinib, Everolimus, Lenvatinib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of three inhibitors Trametinib, Everolimus and LenvatinibDrug
Also called Combination of 3 signaling pathway inhibitors specific to MEK, mTOR, and angiogenesis.
Oral administration of three inhibitors including Trametinib, Everolimus and Lenvatinib.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Combination of three inhibitors Trametinib, Everolimus and Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing Incidence of Treatment-Emergent Adverse Events during the treatment and various responses to the treatment.
Measured: up to 36 months
Secondary outcomes (2)
Assessing progress free survival
Measured: 48 months
Assessing overall survival
Assessing overall time to survival.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Jan 2021
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhenfeng Zhang, MD, PhD, Principal investigator, Second Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803318
- Sponsor's protocol ID
- ZZ3TKI-011
- Status last verified
- Jun 2024
- First submitted
- 15 Mar 2021
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trametinib Combined With Everolimus and Lenvatinib in the Treatment of Recurrent/Refractory Advanced Solid Tumors: a Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT04803318
- Acronym / sponsor ID
- ZZ3TKI-011
- Conditions
- Solid Tumor, Adult, Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma;Lung Cancer, Trametinib, Everolimus, Lenvatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2037 (estimated)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To treat recurrent or refractory advanced solid tumors with multiple targeting drugs that inhibit several critical signaling pathways in cancer cells.
| Arm | Type | Receives |
|---|---|---|
| Combination treatment of 3 inhibitors | Experimental | Drug: Combination of three inhibitors Trametinib, Everolimus and LenvatinibOral administration of 3 signaling pathways inhibitors: Mek inhibitor Trametinib, mTOR inhibitor Everolimus, and angiogenesis inhibitor Lenvatinib on refractory advanced solid tumors. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recurrent/Refractory advanced solid tumors
- Age between 18 and 85 years
- Expected life expectancy is greater than three months
Key exclusion criteria (4 listed)
- Benign tumor
- Life expectancy is less than three months
- Serious medical commodities
- others
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination of three inhibitors Trametinib, Everolimus and LenvatinibAlso: Combination of 3 signaling pathway inhibitors specific to MEK, mTOR, and angiogenesis.Oral administration of three inhibitors including Trametinib, Everolimus and Lenvatinib. | Drug | Combination treatment of 3 inhibitors |
Primary outcome
Assessing Incidence of Treatment-Emergent Adverse Events during the treatment and various responses to the treatment.
Time frame: up to 36 months
2 secondary outcomes
Assessing progress free survival
Time frame: 48 months
Assessing overall survival
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhenfeng Zhang, MD, PhD principal investigator
Second Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combination of three inhibitors Trametinib, Everolimus and Lenvatinib in people with Solid Tumor, Adult and Hepatocellular Carcinoma, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenfeng Zhang, MD, PhD (+862039195966, zhangzhf@gzhmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing Incidence of Treatment-Emergent Adverse Events during the treatment and various responses to the treatment. (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.