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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01836679
Recruitment Status : Completed
First Posted : April 22, 2013
Last Update Posted : February 1, 2016
Sponsor:
Information provided by (Responsible Party):
Chipscreen Biosciences, Ltd.

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.

Condition or disease Intervention/treatment Phase
Non-small-cell Lung Cancer Drug: Chidamide Drug: Paclitaxel Drug: Carboplatin Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : April 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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: Chidamide
Given orally
Other Name: CS055

Drug: Paclitaxel
Given IV
Other Names:
  • Taxol
  • TAX

Drug: Carboplatin
Given IV
Other Names:
  • CBDCA
  • Paraplatin

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: Paclitaxel
Given IV
Other Names:
  • Taxol
  • TAX

Drug: Carboplatin
Given IV
Other Names:
  • CBDCA
  • Paraplatin

Drug: Placebo
Given orally
Other Name: PLB




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836679


Locations
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China, Beijing
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100021
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing, China, 101149
China, Hebei
Hebei Provincial Tumor Hospital
Shijiazhuang, Hebei, China, 050011
China, Jiangsu
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China, 210009
China, Liaoning
The first Hospital of China Medical University
Shenyang, Liaoning, China, 110001
China, Shanghai
Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University
Shanghai, Shanghai, China, 200030
China, Sichuan
The Second People's Hospital of Sichuan
Chengdu, Sichuan, China, 82816
China, Tianjin
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin, China, 300060
Sponsors and Collaborators
Chipscreen Biosciences, Ltd.
Investigators
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Principal Investigator: Yuankai Shi Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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Responsible Party: Chipscreen Biosciences, Ltd.
ClinicalTrials.gov Identifier: NCT01836679    
Other Study ID Numbers: CDM204
First Posted: April 22, 2013    Key Record Dates
Last Update Posted: February 1, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Chipscreen Biosciences, Ltd.:
Chidamide,lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action