Digestive System TumorsPhase 1NCT04615312

A Trail of CDK4 / 6 Inhibitor and MEK Inhibitor in the Treatment of Metastatic Digestive System Tumors

A Phase 1 study testing a CDK4 / 6 inhibitor and a MEK inhibitor in people with Digestive System Tumors, run by Henan Cancer Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

This is a prospective, open, phase I clinical study to evaluate the safety and tolerability of a CDK4 / 6 inhibitor and a MEK inhibitor in the treatment of metastatic digestive system tumors Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Digestive System Tumors
What is being tested?: a CDK4 / 6 inhibitor and a MEK inhibitor
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteChina
Study dates: 14 Nov 2020to 30 Aug 2022
Phase: Phase 1
Are there results?: None posted in the registry

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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged 18-75 years;
ECOG score ≤ 1;
Patients with advanced KRAS mutation or metastatic digestive system tumor confirmed by histology or cytology and imaging diagnosis;
According to Recist1.1, there was at least one measurable lesion;
The expected survival time was more than 12 weeks;

Who cannot join

Patients who received any anti-tumor treatment within 4 weeks before enrollment, including radiotherapy, chemotherapy, molecular targeted therapy and immunotherapy, or participated in another intervention clinical trial;
Previous treatment with targeted BRAF, MEK, ERK or CDK family related inhibitors;
The third space effusion (such as massive pleural effusion or ascites) with clinical symptoms that cannot be controlled by drainage or other methods;
Allergy to any test drug and its excipients, or serious allergic history, or contraindication of the test drug;
Have a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;

Trial locations and contacts

1 site in 1 country.

Ning Li, PhD contact

13526501903

lining97@126.com

China1 site, 1 recruiting

Henan Cancer Hospital
Zhengzhou, Henan, 450008
Ning Li, PhD, 0086-13526501903, lining97@126.com
Ning Li, PhD
Recruiting

Other trials in China

About this study

Official title: Phase I Clinical Study on the Safety and Tolerability of a CDK4 / 6 Inhibitor and a MEK Inhibitor in the Treatment of Metastatic Digestive System Tumors

This is a prospective, open, phase I clinical study to evaluate the safety and tolerability of a CDK4 / 6 inhibitor and a MEK inhibitor in the treatment of metastatic digestive system tumors

Conditions: Digestive System Tumors
Being tested: a CDK4 / 6 inhibitor and a MEK inhibitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

a CDK4 / 6 inhibitor and a MEK inhibitorDrug
Participant will receive a CDK4 / 6 inhibitor and a MEK inhibitor treatment to determine the maximum tolerated dose

Study groups in NCT04615312
Study group	Role	What they receive
a CDK4 / 6 inhibitor and a MEK inhibitor	Experimental	Participants will receive a CDK4 / 6 inhibitor and a MEK inhibitor treatment Receives: Drug: a CDK4 / 6 inhibitor and a MEK inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

To determine the maximum tolerated dose of a CDK4 / 6 inhibitor and a MEK inhibitor therapy
Measured: Up to approximately 24 months

Secondary outcomes (1)

ORR
the Objective Remission Rate
Measured: Up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Nov 202030 Aug 2022

First posted4 Nov 2020
Study start14 Nov 2020
Primary completion30 Aug 2021 (estimated)
Study completion30 Aug 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Digestive System TumorsStudies of the same condition, open and under way.
More trials run by Henan Cancer HospitalThe 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04615312
Sponsor's protocol ID: CRC-PANC-IIT-SHR6390-SHR7390
Status last verified: Aug 2021
First submitted: 29 Oct 2020
Last updated: 23 Aug 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Ning Li, PhD

13526501903

lining97@126.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms

All Digestive System Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Clinical Study on the Safety and Tolerability of a CDK4 / 6 Inhibitor and a MEK Inhibitor in the Treatment of Metastatic Digestive System Tumors
ClinicalTrials.gov ID: NCT04615312
Acronym / sponsor ID: CRC-PANC-IIT-SHR6390-SHR7390
Conditions: Digestive System Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 50 participants (estimated)
Lead sponsor: Henan Cancer HospitalOther government
Study start: 14 Nov 2020 (actual)
Primary completion: 30 Aug 2021 (estimated)
Study completion: 30 Aug 2022 (estimated)
First posted: 4 Nov 2020 (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.

This is a prospective, open, phase I clinical study to evaluate the safety and tolerability of a CDK4 / 6 inhibitor and a MEK inhibitor in the treatment of metastatic digestive system tumors

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
a CDK4 / 6 inhibitor and a MEK inhibitor	Experimental	Drug: a CDK4 / 6 inhibitor and a MEK inhibitorParticipants will receive a CDK4 / 6 inhibitor and a MEK inhibitor treatment

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Aged 18-75 years;
ECOG score ≤ 1;
Patients with advanced KRAS mutation or metastatic digestive system tumor confirmed by histology or cytology and imaging diagnosis;
According to Recist1.1, there was at least one measurable lesion;
The expected survival time was more than 12 weeks;

Key exclusion criteria (5 listed)

Patients who received any anti-tumor treatment within 4 weeks before enrollment, including radiotherapy, chemotherapy, molecular targeted therapy and immunotherapy, or participated in another intervention clinical trial;
Previous treatment with targeted BRAF, MEK, ERK or CDK family related inhibitors;
The third space effusion (such as massive pleural effusion or ascites) with clinical symptoms that cannot be controlled by drainage or other methods;
Allergy to any test drug and its excipients, or serious allergic history, or contraindication of the test drug;
Have a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;

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
a CDK4 / 6 inhibitor and a MEK inhibitorParticipant will receive a CDK4 / 6 inhibitor and a MEK inhibitor treatment to determine the maximum tolerated dose	Drug	a CDK4 / 6 inhibitor and a MEK inhibitor

Primary outcome

To determine the maximum tolerated dose of a CDK4 / 6 inhibitor and a MEK inhibitor therapy
Time frame: Up to approximately 24 months

1 secondary outcome

ORR
Time frame: Up to approximately 24 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
Individual participant dataSharing planned: No

Related trials for Digestive System Tumors

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms

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. This study is not recruiting at the moment.

Ning Li, PhD contact

13526501903

lining97@126.com

Ning Li, PhD principal investigator

Henan Cancer Hospital

Suxia Luo, PhD principal investigator

Henan Cancer Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing a CDK4 / 6 inhibitor and a MEK inhibitor in people with Digestive System Tumors, run by Henan Cancer Hospital 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Aug 2021. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ning Li, PhD (13526501903, lining97@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the maximum tolerated dose of a CDK4 / 6 inhibitor and a MEK inhibitor therapy (time frame: Up to approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04615312.

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 23 Aug 2021.