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

NCT01836679 | Completed Phase 2

• 1 other identifier: CDM204
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 8

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.

Conditions

Non-small-cell Lung Cancer

Keywords

Chidamide,lung cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  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 Outcomes (5)

• Progression-Free Survival Rate at 6 Months (6-M-PFS)

  6 months

• Object Response Rate (ORR)

  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)

  From the first date of response until the date of first documented progression, assessed up to 70 weeks

• Overall Survival (OS)

  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

  From the start date of maintenance therapy until the date of first documented progression, assessed up to 64 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

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; Drug: Paclitaxel; Drug: Carboplatin

Arm 2

PLACEBO COMPARATOR

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; Drug: Carboplatin; Drug: Placebo

Interventions

Chidamide DRUG

Given orally

Also known as: CS055

Arm 1

Paclitaxel DRUG

Given IV

Also known as: Taxol, TAX

Arm 1; Arm 2

Carboplatin DRUG

Given IV

Also known as: CBDCA, Paraplatin

Arm 1; Arm 2

Placebo DRUG

Given orally

Also known as: PLB

Arm 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

Study Sites (8)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, 101149, China

Location

Hebei Provincial Tumor Hospital

Shijiazhuang, Hebei, 050011, China

Location

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009, China

Location

The first Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200030, China

Location

The Second People's Hospital of Sichuan

Chengdu, Sichuan, 82816, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Paclitaxel; Taxes; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Coordination Complexes

Study Officials

• Yuankai Shi

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: April 22, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 1, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)