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Chidamide in Combination With Carboplatin and Paclitaxel in Advanced Non-small Cell Lung Cancer

Primary Purpose

Non-small-cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chidamide
Paclitaxel
Carboplatin
Placebo
Sponsored by
Chipscreen Biosciences, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small-cell Lung Cancer focused on measuring Chidamide,lung cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with histology or cytology confirmed non-small-cell lung cancer,stage IIIb or IV. Newly diagnosed or relapsed after surgery but have not received systemic drug therapy.Adjuvant chemotherapy after surgery should have completed for more than one year at study entry.
  • Aged 18~75 years
  • Epidermal growth factor receptor (EGFR) mutation negative or EGFR status is unknown
  • With at least one measurable lesion
  • White blood cell count≥4×10^9/L,platelet count≥100×10^9/L and hemoglobin≥11g/L
  • Life expectancy >3 months
  • Eastern Cooperative Oncology Group performance status of ≤1 at study entry
  • Women of childbearing age should have pregnancy test negative and would like to conduct birth control during the study
  • Have signed informed consent

Exclusion Criteria:

  • Patients with clinically significant corrected QT interval prolongation, or ventricular tachycardia,or auricular fibrillation, or ≥Grade 2 sino-auricular heart-block,or ≥Grade 3 atrioventricular block,or myocardial infarction within one year, or congestive heart failure,or patients with symptomatic coronary disease which need to be treated by drug
  • The size of fluid area detected by cardiac ultrasonography in cavum pericardium is ≥10mm during diastolic period
  • Organ transplant patients
  • Patients with active bleeding or new thrombotic diseases
  • Patients with body temperature >38.5℃ for more than 3 days
  • Total bilirubin >1.5 fold of upper limit of normal (ULN), ALT/AST>1.5 fold of ULN or serum creatine >1.5 fold of ULN
  • Patients with symptomatic brain-metastasis
  • Pregnant or lactating women
  • Patients with mental disorder

Sites / Locations

  • Cancer Hospital, Chinese Academy of Medical Sciences
  • Beijing Chest Hospital, Capital Medical University
  • Hebei Provincial Tumor Hospital
  • Jiangsu Cancer Hospital
  • The first Hospital of China Medical University
  • Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University
  • The Second People's Hospital of Sichuan
  • Tianjin Medical University Cancer Institute & Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.The chemotherapy cycles are repeated every 3 weeks to a maximum of 4 cycles. Patients also receive Chidamide 20mg orally twice a week until disease progression,or unacceptable toxicities,or withdrawal of consent occurred.

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.The chemotherapy cycles are repeated every 3 weeks to a maximum of 4 cycles. Patients also receive placebo orally twice a week until disease progression,or unacceptable toxicities,or withdrawal of consent occurred.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)
PFS is measured from the start of treatment until progression or death,whichever is first met

Secondary Outcome Measures

Progression-Free Survival Rate at 6 Months (6-M-PFS)
6-M-PFS is defined as the percentage of participants whose disease is still progression-free at the 6th month
Object Response Rate (ORR)
ORR is defined as percentage of participants with Complete Response and Partial Response,assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Duration of Response (DOR)
DOR is measured from the first date when criteria for response is met until the first date when the criteria for progression is met
Overall Survival (OS)
OS is measured from the start of treatment until death
Time To Progression (TTP) during the maintenance therapy period
TTP is assessed for patients who complete the 12 weeks of combination therapy. It is measured from the start of maintenance therapy until the criteria of progression is met

Full Information

First Posted
April 12, 2013
Last Updated
January 28, 2016
Sponsor
Chipscreen Biosciences, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01836679
Brief Title
Chidamide in Combination With Carboplatin and Paclitaxel in Advanced Non-small Cell Lung Cancer
Official Title
A Phase II Study of Chidamide or Placebo in Combination With Carboplatin and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chipscreen Biosciences, Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Chidamide combined with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer.
Detailed Description
The study is to evaluate efficacy which includes the progression free survival (PFS), PFS at 6 months, objective response rate, duration of response rate, overall survival and time to progression, and safety which include adverse events, vital signs, laboratory tests, of the treatment of chidamide plus paclitaxel and carboplatin in patients with advanced non small cell lung cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small-cell Lung Cancer
Keywords
Chidamide,lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.The chemotherapy cycles are repeated every 3 weeks to a maximum of 4 cycles. Patients also receive Chidamide 20mg orally twice a week until disease progression,or unacceptable toxicities,or withdrawal of consent occurred.
Arm Title
Arm 2
Arm Type
Placebo Comparator
Arm Description
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.The chemotherapy cycles are repeated every 3 weeks to a maximum of 4 cycles. Patients also receive placebo orally twice a week until disease progression,or unacceptable toxicities,or withdrawal of consent occurred.
Intervention Type
Drug
Intervention Name(s)
Chidamide
Other Intervention Name(s)
CS055
Intervention Description
Given orally
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol, TAX
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
CBDCA, Paraplatin
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
PLB
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
PFS is measured from the start of treatment until progression or death,whichever is first met
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 76 weeks
Secondary Outcome Measure Information:
Title
Progression-Free Survival Rate at 6 Months (6-M-PFS)
Description
6-M-PFS is defined as the percentage of participants whose disease is still progression-free at the 6th month
Time Frame
6 months
Title
Object Response Rate (ORR)
Description
ORR is defined as percentage of participants with Complete Response and Partial Response,assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame
Response is assessed once every 6 weeks (combination therapy period) for up to 12 weeks, and once every 8 weeks (maintenance therapy period) for up to 64 weeks
Title
Duration of Response (DOR)
Description
DOR is measured from the first date when criteria for response is met until the first date when the criteria for progression is met
Time Frame
From the first date of response until the date of first documented progression, assessed up to 70 weeks
Title
Overall Survival (OS)
Description
OS is measured from the start of treatment until death
Time Frame
From date of randomization until the date of death from any cause, followed for up to 76 weeks
Title
Time To Progression (TTP) during the maintenance therapy period
Description
TTP is assessed for patients who complete the 12 weeks of combination therapy. It is measured from the start of maintenance therapy until the criteria of progression is met
Time Frame
From the start date of maintenance therapy until the date of first documented progression, assessed up to 64 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with histology or cytology confirmed non-small-cell lung cancer,stage IIIb or IV. Newly diagnosed or relapsed after surgery but have not received systemic drug therapy.Adjuvant chemotherapy after surgery should have completed for more than one year at study entry. Aged 18~75 years Epidermal growth factor receptor (EGFR) mutation negative or EGFR status is unknown With at least one measurable lesion White blood cell count≥4×10^9/L,platelet count≥100×10^9/L and hemoglobin≥11g/L Life expectancy >3 months Eastern Cooperative Oncology Group performance status of ≤1 at study entry Women of childbearing age should have pregnancy test negative and would like to conduct birth control during the study Have signed informed consent Exclusion Criteria: Patients with clinically significant corrected QT interval prolongation, or ventricular tachycardia,or auricular fibrillation, or ≥Grade 2 sino-auricular heart-block,or ≥Grade 3 atrioventricular block,or myocardial infarction within one year, or congestive heart failure,or patients with symptomatic coronary disease which need to be treated by drug The size of fluid area detected by cardiac ultrasonography in cavum pericardium is ≥10mm during diastolic period Organ transplant patients Patients with active bleeding or new thrombotic diseases Patients with body temperature >38.5℃ for more than 3 days Total bilirubin >1.5 fold of upper limit of normal (ULN), ALT/AST>1.5 fold of ULN or serum creatine >1.5 fold of ULN Patients with symptomatic brain-metastasis Pregnant or lactating women Patients with mental disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuankai Shi
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Beijing Chest Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101149
Country
China
Facility Name
Hebei Provincial Tumor Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050011
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
The first Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Name
Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
The Second People's Hospital of Sichuan
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
82816
Country
China
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Chidamide in Combination With Carboplatin and Paclitaxel in Advanced Non-small Cell Lung Cancer

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