Metastatic Colorectal CancerPhase 1NCT05281276

Chidamide + Celecoxib in Advanced Metastatic Colorectal Cancer (CCmCC)

A Phase 1 study testing chidamide and celecoxib in people with Metastatic Colorectal Cancer, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study is designed as an open-label, dose-escalation manner to determine the MFD of chidamide in combination with celecoxib in patients with advanced mCRC. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Metastatic Colorectal Cancer
What is being tested?: chidamide and celecoxib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteTaiwan
Study dates: 20 Sep 2022to 26 Mar 2024
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The patient is 20-year-old or older on the day that consent is provided.
With histologically or cytologically proven metastatic colorectal adenocarcinoma.
Have measurable lesions according to RECIST v1.1.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 to 2.
Adequate organ function as defined below:
White blood cells (WBC) ≥3,000/μL ii. Absolute neutrophil count ≥1,500/μL iii. Platelets ≥1 x 105/μL iv. Hemoglobin ≥9.0 g/dL v. Total bilirubin ≤1.5 x the upper limit of normal (ULN) vi. AST(SGOT)/ALT(SGPT) ≤3 x ULN (or ≤5 x ULN if liver metastases are present) vii. Serum creatinine ≤1.5 x ULN

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Patients who had received or were intolerant of at least 2 front-line systemic treatments. In addition, patients have failed or refused all available standard treatment, or were intolerant of such treatments. For K-ras wild type tumor, anti-EGFR therapy must have been done. For K-ras mutant tumor, antiangiogenic therapy must have been done.
Able to take oral medication.
With a life expectancy of at least 3 months.
Female patients of childbearing potential must have a negative urine or serum pregnancy test.
Patients in reproductive age must be willing to use adequate contraception (refer to Section 8.4.2 of the protocol for adequate contraception methods) during the study and 3 months after the end of the study.
Ability to understand and the willingness to provide a written informed consent document.

Who cannot join

Inclusion criteria:
The patient is 20-year-old or older on the day that consent is provided.
With histologically or cytologically proven metastatic colorectal adenocarcinoma.
Have measurable lesions according to RECIST v1.1.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 to 2.
Adequate organ function as defined below:

Show all 31Show fewer

White blood cells (WBC) ≥3,000/μL ii. Absolute neutrophil count ≥1,500/μL iii. Platelets ≥1 x 105/μL iv. Hemoglobin ≥9.0 g/dL v. Total bilirubin ≤1.5 x the upper limit of normal (ULN) vi. AST(SGOT)/ALT(SGPT) ≤3 x ULN (or ≤5 x ULN if liver metastases are present) vii. Serum creatinine ≤1.5 x ULN
Patients who had received or were intolerant of at least 2 front-line systemic treatments. In addition, patients have failed or refused all available standard treatment, or were intolerant of such treatments. For K-ras wild type tumor, anti-EGFR therapy must have been done. For K-ras mutant tumor, antiangiogenic therapy must have been done.
Able to take oral medication.
With a life expectancy of at least 3 months.
Female patients of childbearing potential must have a negative urine or serum pregnancy test.
Patients in reproductive age must be willing to use adequate contraception (refer to Section 8.4.2 of the protocol for adequate contraception methods) during the study and 3 months after the end of the study.
Ability to understand and the willingness to provide a written informed consent document.
Exclusion criteria:
With known central nervous system (CNS) metastases, a history of CNS metastases or leptomeningeal diseases.
With known hypersensitivity towards chidamide, celecoxib, sulfonamides, aspirin, NSAIDs, or any other agents used in the study, including the excipient in the study agent; or with history of asthma, urticarial, or other allergic-type reactions after taking aspirin or other NSAIDs.
With severe systemic disease, such as renal disease (serum creatinine >1.5 x ULN), liver disease (AST/ALT >3 x ULN, AST/ALT >5 x ULN if metastatic liver disease were known), active gastrointestinal hemorrhage or increased risks of gastrointestinal bleeding, uncontrolled diabetes, or uncontrolled hypertension.
With uncontrolled or significant cardiovascular diseases, including:
Symptomatic congestive heart failure within 6 months prior to screening, or left ventricular ejection fraction <50% prior to screening ii. Myocardial infarction within 12 months prior to screening iii. Severe or unstable angina within 6 months prior to screening iv. History of any significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or TdP) v. History of significant QT interval prolongation, or corrected QT interval (QTc) >450 ms prior to screening vi. History of cerebrovascular accident vii. Symptomatic coronary heart disease requiring treatment with agents
With the size of fluid area detected by cardiac ultrasonography in cavum pericardium ≥ 10 mm.
With history of organ transplantation.
With known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
With autoimmune disorders or history of organ transplantation who require immunosuppressive therapy.
Has had prior chemotherapy, targeted small molecule therapy, radiation therapy, or any NSAID within 2 weeks prior to the first dose of study medication or who has not recovered from adverse events to CTCAE v5.0 Grade 1 due to a previously administered agent.
Has clinical significant gastrointestinal abnormality, e.g., unable to swallow, chronic diarrhea, ileus, or bowel obstruction, which would interfere the ingestion, transportation, or absorption of oral agents.
With active infection [suffered from active infection of bacteria, virus, fungi, mycobacteria, parasites, or other infections (excluding nail bed fungal infections), or require intravenous antibiotic therapy, or antiviral therapy, or hospitalization due to any significant infection events within 4 weeks], or persistent fever within 14 days prior to study entry.
Had major surgery <6 weeks prior to study entry.
Has known psychiatric disorder, mental deficiency, or substance abuse disorder that would limit compliance with study requirements.
Is currently participating and receiving study therapy, or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks of the first dose of study medication.
Pregnant or lactating female.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might interfere the results of the trial or is not in the best interest of the subject to participate, in the opinion of the investigator.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Taipei Medical University Shuang Ho Hospital
New Taipei City

Other trials in Taiwan

About this study

Official title: A Phase Ib Study of Chidamide in Combination With Celecoxib in Patients With Metastatic Colorectal Cancer Who Had Progression or Were Intolerant of at Least Two Lines of Systemic Therapies (CCmCC)

This study is designed as an open-label, dose-escalation manner to determine the MFD of chidamide in combination with celecoxib in patients with advanced mCRC.

Read the detailed description

This is a monocentric, open-label, non-randomized dose feasibility study trial to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of chidamide in combination with celecoxib in patients with advanced mCRC. Each cohort will have up to 6 subjects. Eligible patients will be assigned to 1 of up to 2 sequential cohorts. The planned dose levels of the two cohorts include (1) 20 mg chidamide plus 200 mg celecoxib; and (2) 30 mg chidamide plus 200 mg celecoxib.

For each subject, the treatment period is divided into two periods, a run-in period and a combination therapy period.

Conditions: Metastatic Colorectal Cancer
Being tested: chidamide, celecoxib
Keywords: Metastatic Colorectal Cancer
Medical subject headings: Colorectal Neoplasms

What participants receive

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

chidamideDrug
Also called tucidinostat, HBI-8000
During the run-in period, the patients will take a single dose of chidamide on Day 3. In a 28-day treatment cycle, the dosing schedule is four/six table (20/30mg) BIW .
celecoxibDrug
Also called Celebrex
During the run-in period, the patients will take a single dose of celecoxib on Day 1. In a treatment cycle, the dosing schedule is one capsule(200 mg) daily.

Study groups in NCT05281276
Study group	Role	What they receive
chidamide (20 mg) BIW in combination with celecoxib (CC)	Experimental	Chidamide: The dosing schedule is four/six tablets (20 mg) BIW, taken at 30 min after breakfast. The interval between two doses in each week should not be less than 3 days. Celecoxib: The dosing schedule is one capsule (200 mg) daily taken at 30 min after breakfast. A treatment cycle is defined as a period of 4 weeks (28 days) Receives: Drug: chidamide; Drug: celecoxib
chidamide(30 mg) BIW in combination with celecoxib (CC)	Experimental	Chidamide: The dosing schedule is four/six tablets (30 mg) BIW, taken at 30 min after breakfast. The interval between two doses in each week should not be less than 3 days. Celecoxib: The dosing schedule is one capsule (200 mg) daily taken at 30 min after breakfast. A treatment cycle is defined as a period of 4 weeks (28 days) Receives: Drug: chidamide; Drug: celecoxib

What is being measured

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

Maximum Feasible Dose (MFD)
Maximum Feasible Dose (MFD): is defined as the highest dose for which ≤1 of 6 evaluable subjects experiencing DLT during the first treatment cycle (28 days) of the combination therapy. If the dose of Cohort 1 is not tolerable by ≥2 evaluable subjects, the MFD will be considered as not determined.
Measured: defined as the highest dose for which ≤1 of 6 evaluable subjects experiencing DLT during the first treatment cycle (28 days) of the combination therapy, assessed up to 24 months
Pharmacokinetics profiles-(AUC0-t)
Area under the plasma concentration-time curve from time zero to time t(AUC0-t)
Measured: Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 & day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.
Pharmacokinetics profiles-(AUC0-∞)
Area under the plasma concentration-time curve from time zero to infinity(AUC0-∞)
Measured: Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 & day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.
Pharmacokinetics profiles-(Cmax)
Maximum plasma concentration(Cmax)
Measured: Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 & day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.
Pharmacokinetics profiles-(Tmax)
Time to maximum plasma concentration(Tmax)
Measured: Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 & day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.
Pharmacokinetics profiles-(T1/2)
Half-life(T1/2)
Measured: Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 & day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.
Pharmacokinetics profiles-(Kel)
Elimination rate constant(Kel)
Measured: Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 & day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.
Pharmacokinetics profiles-(AUC0-τ,ss)
Area under the plasma concentration-time curve from time zero to time τ (dosing interval) at steady state(AUC0-τ,ss)
Measured: Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 & day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.
Pharmacokinetics profiles-(Cave,ss)
Average plasma concentration at steady state(Cave,ss)
Measured: Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 & day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.
Pharmacokinetics profiles-(Cmin,ss)
Minimum (trough) plasma concentration at steady state(Cmin,ss)
Measured: Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 & day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.
Pharmacokinetics profiles-(Cmax,ss)
Maximum (peak) plasma concentration at steady state(Cmax,ss)
Measured: Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 & day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.
Pharmacokinetics profiles-(Tmax,ss)
Time to maximum plasma concentration at steady state(Tmax,ss)
Measured: Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 & day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.
Pharmacokinetics profiles-(DF)
Degree of fluctuation(DF)
Measured: Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 & day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.

Secondary outcomes (2)

Progression-free survival
defined as the time from first day of dosing until the date of first objective disease progression or death. Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of tumor assessment
Measured: from the time of first day of dosing (Run-in period Day1) until the date of first objective disease progression or death, assessed up to 24 months
Objective response
ORR, defined as the percentage of patients with CR and PR of total number of analysis set
Measured: From enrollment until disease progression or unacceptable toxicity, assessed up to 24 months

Timeline

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

20 Sep 202226 Mar 2024

First posted16 Mar 2022
Study start20 Sep 2022
Primary completion26 Mar 2024
Study completion26 Mar 2024

Why it stopped: The overall profile does not support development for metastatic colorectal cancer

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
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: Non-randomised
Intervention model: Sequential
Model description: Cohort1: Chidamide(20mg)+Celecoxib(200mg); Cohort2: Chidamide(30mg)+Celecoxib(200mg)
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05281276
Sponsor's protocol ID: N202007026
Status last verified: Dec 2024
First submitted: 15 Nov 2021
Last updated: 20 Dec 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

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

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Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib Study of Chidamide in Combination With Celecoxib in Patients With Metastatic Colorectal Cancer Who Had Progression or Were Intolerant of at Least Two Lines of Systemic Therapies (CCmCC)
ClinicalTrials.gov ID: NCT05281276
Acronym / sponsor ID: N202007026
Conditions: Metastatic Colorectal Cancer
Keywords: Metastatic Colorectal Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The overall profile does not support development for metastatic colorectal cancer
Enrolment: 9 participants (actual)
Lead sponsor: Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
Study start: 20 Sep 2022 (actual)
Primary completion: 26 Mar 2024 (actual)
Study completion: 26 Mar 2024 (actual)
First posted: 16 Mar 2022 (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 study is designed as an open-label, dose-escalation manner to determine the MFD of chidamide in combination with celecoxib in patients with advanced mCRC.

Detailed description

For each subject, the treatment period is divided into two periods, a run-in period and a combination therapy period.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: Cohort1: Chidamide(20mg)+Celecoxib(200mg); Cohort2: Chidamide(30mg)+Celecoxib(200mg)

Arm	Type	Receives
chidamide (20 mg) BIW in combination with celecoxib (CC)	Experimental	Drug: chidamide, Drug: celecoxibChidamide: The dosing schedule is four/six tablets (20 mg) BIW, taken at 30 min after breakfast. The interval between two doses in each week should not be less than 3 days. Celecoxib: The dosing schedule is one capsule (200 mg) daily taken at 30 min after breakfast. A treatment cycle is defined as a period of 4 weeks (28 days)
chidamide(30 mg) BIW in combination with celecoxib (CC)	Experimental	Drug: chidamide, Drug: celecoxibChidamide: The dosing schedule is four/six tablets (30 mg) BIW, taken at 30 min after breakfast. The interval between two doses in each week should not be less than 3 days. Celecoxib: The dosing schedule is one capsule (200 mg) daily taken at 30 min after breakfast. A treatment cycle is defined as a period of 4 weeks (28 days)

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

The patient is 20-year-old or older on the day that consent is provided.
With histologically or cytologically proven metastatic colorectal adenocarcinoma.
Have measurable lesions according to RECIST v1.1.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 to 2.
Adequate organ function as defined below:

Key exclusion criteria (31 listed)

Inclusion criteria:
The patient is 20-year-old or older on the day that consent is provided.
With histologically or cytologically proven metastatic colorectal adenocarcinoma.
Have measurable lesions according to RECIST v1.1.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 to 2.

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
chidamideAlso: tucidinostat, HBI-8000During the run-in period, the patients will take a single dose of chidamide on Day 3. In a 28-day treatment cycle, the dosing schedule is four/six table (20/30mg) BIW .	Drug	chidamide (20 mg) BIW in combination with celecoxib (CC), chidamide(30 mg) BIW in combination with celecoxib (CC)
celecoxibAlso: CelebrexDuring the run-in period, the patients will take a single dose of celecoxib on Day 1. In a treatment cycle, the dosing schedule is one capsule(200 mg) daily.	Drug	chidamide (20 mg) BIW in combination with celecoxib (CC), chidamide(30 mg) BIW in combination with celecoxib (CC)

Primary outcome

Maximum Feasible Dose (MFD)
Time frame: defined as the highest dose for which ≤1 of 6 evaluable subjects experiencing DLT during the first treatment cycle (28 days) of the combination therapy, assessed up to 24 months
Maximum Feasible Dose (MFD): is defined as the highest dose for which ≤1 of 6 evaluable subjects experiencing DLT during the first treatment cycle (28 days) of the combination therapy. If the dose of Cohort 1 is not tolerable by ≥2 evaluable subjects, the MFD will be considered as not determined.
Pharmacokinetics profiles-(AUC0-t)
Time frame: Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 & day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.
Area under the plasma concentration-time curve from time zero to time t(AUC0-t)
Pharmacokinetics profiles-(AUC0-∞)
Time frame: Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 & day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.
Area under the plasma concentration-time curve from time zero to infinity(AUC0-∞)
Pharmacokinetics profiles-(Cmax)
Time frame: Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 & day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.
Maximum plasma concentration(Cmax)
Pharmacokinetics profiles-(Tmax)
Time frame: Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 & day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.
Time to maximum plasma concentration(Tmax)
Pharmacokinetics profiles-(T1/2)
Time frame: Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 & day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.
Half-life(T1/2)
Pharmacokinetics profiles-(Kel)
Time frame: Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 & day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.
Elimination rate constant(Kel)
Pharmacokinetics profiles-(AUC0-τ,ss)
Time frame: Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 & day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.
Area under the plasma concentration-time curve from time zero to time τ (dosing interval) at steady state(AUC0-τ,ss)
Pharmacokinetics profiles-(Cave,ss)
Time frame: Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 & day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.
Average plasma concentration at steady state(Cave,ss)
Pharmacokinetics profiles-(Cmin,ss)
Time frame: Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 & day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.
Minimum (trough) plasma concentration at steady state(Cmin,ss)
Pharmacokinetics profiles-(Cmax,ss)
Time frame: Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 & day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.
Maximum (peak) plasma concentration at steady state(Cmax,ss)
Pharmacokinetics profiles-(Tmax,ss)
Time frame: Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 & day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.
Time to maximum plasma concentration at steady state(Tmax,ss)
Pharmacokinetics profiles-(DF)
Time frame: Run-in period, on day1, blood sample will be 0, 1, 2, 6, 12, and 24 hours; on day3, blood sample will be 0, 1, 2, 6, 12, 24, 48, and 72 hours.Combination therapy period, on day1 & day25, blood sample will be 0, 1, 2, 6, 12, 24, 48 and 72 hours.
Degree of fluctuation(DF)

2 secondary outcomes

Progression-free survival
Time frame: from the time of first day of dosing (Run-in period Day1) until the date of first objective disease progression or death, assessed up to 24 months
Objective response
Time frame: From enrollment until disease progression or unacceptable toxicity, assessed up to 24 months

Results and safety

The study was stopped early (reason given: The overall profile does not support development for metastatic colorectal cancer). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
Individual participant dataSharing planned: Undecided. 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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

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 chidamide and celecoxib in people with Metastatic Colorectal Cancer, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.

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 12 inclusion and 31 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: stopped early, as of the sponsor's last update on 20 Dec 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 Taiwan. 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?

The study was stopped early (reason given: The overall profile does not support development for metastatic colorectal cancer). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Feasible Dose (MFD) (time frame: defined as the highest dose for which ≤1 of 6 evaluable subjects experiencing DLT during the first treatment cycle (28 days) of the combination therapy, assessed up to 24 months). The study lists 13 primary outcomes in all. 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 NCT05281276.

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 20 Dec 2024.