- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01850147
Sequential Use of Low-dose Sunitinib With Chemotherapy in Advanced NSCLC After Failure of Conventional Regimen
May 7, 2013 updated by: LI Junling, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study of Efficacy and Safety of Sequential Low-dose Sunitinib With Chemotherapy in Advanced Non-small Cell Lung Cancer After Failure of Conventional Regimen
The purpose of this study is to determine whether sequential application of low-dose short-term sunitinib and chemotherapy is effective in the treatment of non-small cell lung cancer after failure of conventional therapy.
Safety of this regimen will also be evaluated.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
50
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
-
-
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Beijing, China, 100021
- Recruiting
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologic or cytologic diagnosis of stage IIIB/IV NSCLC
- ECOG PS: 0,1
- Unidimensional or bi-dimensional measurable disease
- Receive prior treatment including first-line platinum-based chemotherapy, standard second-line chemotherapy and 1 EGF/EGFR inhibitor
- Evidence of disease progression
- Life expectancy >12 weeks
- Neutrophils > 1.5 109/l, Platelets > 100 109/l, Hemoglobin > 9g/dl, Total bilirubin < 1.5 UNL, AST (SGOT) and ALT (SGPT) < 2.5 UNL, Alkaline phosphatases < 5 UNL, Creatinine < 1 UNL
Exclusion Criteria:
- Pre-existing hemoptysis of a severity > grade 3 by NCI CTCAE criteria within 4 weeks prior to study entry
- Uncontrolled hypertension
- CHF, angina or arrhythmias
- LVEF < 1 UNL
- Existing a second malignancy within 5 years
- Infected with HIV
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sunitinib
|
sunitinib, 12.5mg/day, for 7 days before each cycle of chemotherapy; chemotherapy, single agent including docetaxel, albumin-bound paclitaxel, vinorelbine, gemcitabine, pemetrexed, or paclitaxel, as determined by the investigator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progression-free survival
Time Frame: up to 2 years
|
The primary objective of this study is to evaluate the median progression-free survival of this sequential regimen.
|
up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: up to 2 years
|
To evaluate the median over-all survival of this regimen
|
up to 2 years
|
disease control rate
Time Frame: up to 6 months
|
To evaluate the disease-control rate of this regimen.
|
up to 6 months
|
Safety
Time Frame: up to 2 years
|
To evaluate the safety of this regimen including the rate and grade of adverse effects.
|
up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
March 1, 2013
Primary Completion (Anticipated)
October 1, 2014
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
April 18, 2013
First Submitted That Met QC Criteria
May 7, 2013
First Posted (Estimate)
May 9, 2013
Study Record Updates
Last Update Posted (Estimate)
May 9, 2013
Last Update Submitted That Met QC Criteria
May 7, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Sunitinib
Other Study ID Numbers
- SU-2013-041
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.
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