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

January 28, 2016 updated by: Chipscreen Biosciences, Ltd.

A Phase II Study of Chidamide or Placebo in Combination With Carboplatin and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Cancer hospital, Chinese Academy of Medical Sciences
      • Beijing, Beijing, China, 101149
        • Beijing Chest hospital, Capital medical university
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Hebei Provincial Tumor Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Jiangsu Cancer Hospital
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • The First Hospital of China Medical University
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Shanghai Chest Hospital Affiliated To Shanghai Jiaotong University
    • Sichuan
      • Chengdu, Sichuan, China, 82816
        • The Second People's Hospital of Sichuan
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Tianjin Medical University Cancer Institute & Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
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.
Drug: Carboplatin
Given IV
Other Names:
  • CBDCA
  • Paraplatin
Drug: Paclitaxel
Given IV
Other Names:
  • Taxol
  • TAX
Drug: Chidamide
Given orally
Other Names:
  • CS055
Placebo Comparator: Arm 2
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.
Drug: Carboplatin
Given IV
Other Names:
  • CBDCA
  • Paraplatin
Drug: Paclitaxel
Given IV
Other Names:
  • Taxol
  • TAX
Drug: Placebo
Given orally
Other Names:
  • PLB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
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
PFS is measured from the start of treatment until progression or death,whichever is first met
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 Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival Rate at 6 Months (6-M-PFS)
Time Frame: 6 months
6-M-PFS is defined as the percentage of participants whose disease is still progression-free at the 6th month
6 months
Object Response Rate (ORR)
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
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)
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
Duration of Response (DOR)
Time Frame: From the first date of response until the date of first documented progression, assessed up to 70 weeks
DOR is measured from the first date when criteria for response is met until the first date when the criteria for progression is met
From the first date of response until the date of first documented progression, assessed up to 70 weeks
Overall Survival (OS)
Time Frame: From date of randomization until the date of death from any cause, followed for up to 76 weeks
OS is measured from the start of treatment until death
From date of randomization until the date of death from any cause, followed for up to 76 weeks
Time To Progression (TTP) during the maintenance therapy period
Time Frame: From the start date of maintenance therapy until the date of first documented progression, assessed up to 64 weeks
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
From the start date of maintenance therapy until the date of first documented progression, assessed up to 64 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chipscreen Biosciences, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 12, 2013

First Submitted That Met QC Criteria

April 17, 2013

First Posted (Estimate)

April 22, 2013

Study Record Updates

Last Update Posted (Estimate)

February 1, 2016

Last Update Submitted That Met QC Criteria

January 28, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDM204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-small-cell Lung Cancer

Clinical Trials on Carboplatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe