Completed

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

What is being tested

Chidamide

+ Paclitaxel

+ Carboplatin

Drug

Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Lung Diseases

From 18 to 75 Years

+18 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 2

Interventional

Study Start: April 2013

See protocol details

Summary

Principal SponsorChipscreen Biosciences, Ltd.

Last updated: February 1, 2016

Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01836679

Principal SponsorChipscreen Biosciences, Ltd.

Last updated: February 1, 2016

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

124 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsCarcinoma, Non-Small-Cell Lung

Criteria

9 inclusion criteria required to participate

Aged 18~75 years

Eastern Cooperative Oncology Group performance status of <= 1 at study entry

Epidermal growth factor receptor (EGFR) mutation negative or EGFR status is unknown

Have signed informed consent

Show More Criteria

9 exclusion criteria prevent from participating

Organ transplant patients

Patients with active bleeding or new thrombotic diseases

Patients with body temperature > 38.5°C for more than 3 days

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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.

Group II

Placebo

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, ChinaOpen Cancer Hospital, Chinese Academy of Medical Sciences in Google Maps

Beijing Chest Hospital, Capital Medical University

Beijing, China

Hebei Provincial Tumor Hospital

Shijiazhuang, China

Jiangsu Cancer Hospital

Nanjing, China

Completed8 Study Centers