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Chidamide + Celecoxib in Advanced Metastatic Colorectal Cancer (CCmCC)

Primary Purpose

Metastatic Colorectal Cancer

Status
Recruiting
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
chidamide
celecoxib
Sponsored by
Taipei Medical University Shuang Ho Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Metastatic Colorectal Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

    i. 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

  6. 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.
  7. Able to take oral medication.
  8. With a life expectancy of at least 3 months.
  9. Female patients of childbearing potential must have a negative urine or serum pregnancy test.
  10. 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.
  11. Ability to understand and the willingness to provide a written informed consent document.

Exclusion Criteria:

(I) Inclusion criteria:

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

    i. 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

  6. 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.
  7. Able to take oral medication.
  8. With a life expectancy of at least 3 months.
  9. Female patients of childbearing potential must have a negative urine or serum pregnancy test.
  10. 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.
  11. Ability to understand and the willingness to provide a written informed consent document.

(II) Exclusion criteria:

  1. With known central nervous system (CNS) metastases, a history of CNS metastases or leptomeningeal diseases.
  2. 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.
  3. 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.
  4. With uncontrolled or significant cardiovascular diseases, including:

    i. 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

  5. With the size of fluid area detected by cardiac ultrasonography in cavum pericardium ≥ 10 mm.
  6. With history of organ transplantation.
  7. With known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
  8. With autoimmune disorders or history of organ transplantation who require immunosuppressive therapy.
  9. 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.
  10. 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.
  11. 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.
  12. Had major surgery <6 weeks prior to study entry.
  13. Has known psychiatric disorder, mental deficiency, or substance abuse disorder that would limit compliance with study requirements.
  14. 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.
  15. Pregnant or lactating female.
  16. 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.

Sites / Locations

  • Taipei Medical University Shuang Ho HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

chidamide (20 mg) BIW in combination with celecoxib (CC)

chidamide(30 mg) BIW in combination with celecoxib (CC)

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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.
Pharmacokinetics profiles-(AUC0-t)
Area under the plasma concentration-time curve from time zero to time t(AUC0-t)
Pharmacokinetics profiles-(AUC0-∞)
Area under the plasma concentration-time curve from time zero to infinity(AUC0-∞)
Pharmacokinetics profiles-(Cmax)
Maximum plasma concentration(Cmax)
Pharmacokinetics profiles-(Tmax)
Time to maximum plasma concentration(Tmax)
Pharmacokinetics profiles-(T1/2)
Half-life(T1/2)
Pharmacokinetics profiles-(Kel)
Elimination rate constant(Kel)
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)
Pharmacokinetics profiles-(Cave,ss)
Average plasma concentration at steady state(Cave,ss)
Pharmacokinetics profiles-(Cmin,ss)
Minimum (trough) plasma concentration at steady state(Cmin,ss)
Pharmacokinetics profiles-(Cmax,ss)
Maximum (peak) plasma concentration at steady state(Cmax,ss)
Pharmacokinetics profiles-(Tmax,ss)
Time to maximum plasma concentration at steady state(Tmax,ss)
Pharmacokinetics profiles-(DF)
Degree of fluctuation(DF)

Secondary Outcome Measures

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
Objective response
ORR, defined as the percentage of patients with CR and PR of total number of analysis set

Full Information

First Posted
November 15, 2021
Last Updated
March 4, 2022
Sponsor
Taipei Medical University Shuang Ho Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05281276
Brief Title
Chidamide + Celecoxib in Advanced Metastatic Colorectal Cancer (CCmCC)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Metastatic Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Cohort1: Chidamide(20mg)+Celecoxib(200mg); Cohort2: Chidamide(30mg)+Celecoxib(200mg)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
chidamide (20 mg) BIW in combination with celecoxib (CC)
Arm Type
Experimental
Arm Description
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)
Arm Title
chidamide(30 mg) BIW in combination with celecoxib (CC)
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
chidamide
Other Intervention Name(s)
tucidinostat, HBI-8000
Intervention Description
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 .
Intervention Type
Drug
Intervention Name(s)
celecoxib
Other Intervention Name(s)
Celebrex
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum Feasible Dose (MFD)
Description
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.
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
Title
Pharmacokinetics profiles-(AUC0-t)
Description
Area under the plasma concentration-time curve from time zero to time t(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.
Title
Pharmacokinetics profiles-(AUC0-∞)
Description
Area under the plasma concentration-time curve from time zero to infinity(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.
Title
Pharmacokinetics profiles-(Cmax)
Description
Maximum plasma concentration(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.
Title
Pharmacokinetics profiles-(Tmax)
Description
Time to maximum plasma concentration(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.
Title
Pharmacokinetics profiles-(T1/2)
Description
Half-life(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.
Title
Pharmacokinetics profiles-(Kel)
Description
Elimination rate constant(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.
Title
Pharmacokinetics profiles-(AUC0-τ,ss)
Description
Area under the plasma concentration-time curve from time zero to time τ (dosing interval) at steady state(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.
Title
Pharmacokinetics profiles-(Cave,ss)
Description
Average plasma concentration at steady state(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.
Title
Pharmacokinetics profiles-(Cmin,ss)
Description
Minimum (trough) plasma concentration at steady state(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.
Title
Pharmacokinetics profiles-(Cmax,ss)
Description
Maximum (peak) plasma concentration at steady state(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.
Title
Pharmacokinetics profiles-(Tmax,ss)
Description
Time to maximum plasma concentration at steady state(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.
Title
Pharmacokinetics profiles-(DF)
Description
Degree of fluctuation(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.
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
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
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
Title
Objective response
Description
ORR, defined as the percentage of patients with CR and PR of total number of analysis set
Time Frame
From enrollment until disease progression or unacceptable toxicity, assessed up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: i. 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: (I) 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: i. 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. (II) 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: i. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tsu-Yi Chao
Phone
+886-970746900
Email
10575@s.tmu.edu.tw
Facility Information:
Facility Name
Taipei Medical University Shuang Ho Hospital
City
New Taipei City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsu-Yi Chao
Phone
+886-22490088
Ext
8878
Email
10575@s.tmu.edu.tw
First Name & Middle Initial & Last Name & Degree
Hao-Ting Chien
Phone
+886-22490088
Ext
887
Email
16608@s.tmu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undecided

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Chidamide + Celecoxib in Advanced Metastatic Colorectal Cancer (CCmCC)

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