Back to resultsIcotinib and Arsenic Trioxide in Treating Non-small-cell Lung Cancer Patients With Resistance to EGFR-TKI
Primary Purpose
Non-small Cell Lung Cancer
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Icotinib
Arsenic trioxide
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Icotinib, Arsenic Trioxide, Resistance, Non-small cell lung cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed stage IIIB/IV lung cancer with EGFR mutation
- Progressed after platinum-based chemotherapy
- The last anti-tumor therapy before entering this study must be gefitinib, erlotinib or icotinib, and the duration for tumor response must be no less than 4 months, or the duration for stable disease must be no less than 6 months
- With a measurable disease with conventional CT) according to RECIST Criteria
- WHO performance status(PS)<= 2
- N>=1.5×109/L, Plt>=1.0×109/L,Hb>=9g/dL; AST&ALT should <2.5ULN(without liver metastasis) or <5ULN(with liver metastasis).TBIL<=1.5ULN.
- Signed and dated informed consent before the start of specific protocol procedures.
Exclusion Criteria:
- Allergic to icotinib or arsenic trioxide.
- Patients with metastatic brain tumors with symptoms.
- Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
Sites / Locations
- Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Icotinib and arsenic trioxide
Arm Description
Icotinib is administered 125 mg three times per day, until disease progression or untolerated toxicity. Arsenic trioxide is administered by intravenous injection with an initial dose of 4mg/m2 per day for day 1 to day 14 every 21 days. Three dose levels, 4mg/m2, 6mg/m2 and 8mg/m2 will be evaluated according to predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 2 patients developed a DLT. There was no further dose escalation when this dose was achieved.
Outcomes
Primary Outcome Measures
Number of Participants with Serious and Non-Serious Adverse Events
Secondary Outcome Measures
Progression-free survival
Time to death
Full Information
NCT ID
NCT02066870
First Posted
February 17, 2014
Last Updated
March 12, 2015
Sponsor
Betta Pharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02066870
Brief Title
Icotinib and Arsenic Trioxide in Treating Non-small-cell Lung Cancer Patients With Resistance to EGFR-TKI
Official Title
Phase I Study of the Combination of Icotinib and Arsenic Trioxide in Treating Non-small-cell Lung Cancer Patients With Resistance to EGFR-TKI
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Betta Pharmaceuticals Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The NSCLC patients who experienced good clinical responses to an EGFR-TKI will inevitably develop acquired resistance. A great deal of research are focusing on this issue. Arsenic trioxide showed efficacy and safety in acute promyelocytic leukemia, multiple myeloma and other solid tumors. Moreover, preclinical studies showed arsenic trioxide can reduce the resistance of tumor cells to chemotherapy and TKIs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Icotinib, Arsenic Trioxide, Resistance, Non-small cell lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Icotinib and arsenic trioxide
Arm Type
Experimental
Arm Description
Icotinib is administered 125 mg three times per day, until disease progression or untolerated toxicity.
Arsenic trioxide is administered by intravenous injection with an initial dose of 4mg/m2 per day for day 1 to day 14 every 21 days.
Three dose levels, 4mg/m2, 6mg/m2 and 8mg/m2 will be evaluated according to predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 2 patients developed a DLT. There was no further dose escalation when this dose was achieved.
Intervention Type
Drug
Intervention Name(s)
Icotinib
Other Intervention Name(s)
BPI-9000, Commana
Intervention Description
Icotinib is administered orally 125 mg three times per day, until disease progression or untolerated toxicity.
Intervention Type
Drug
Intervention Name(s)
Arsenic trioxide
Other Intervention Name(s)
Arsenic trioxide for injection
Intervention Description
Arsenic trioxide is administered by intravenous injection with an initial dose of 4mg/m2 per day for day 1 to day 14 every 21 days.
Three dose levels, 4mg/m2, 6mg/m2 and 8mg/m2 will be evaluated according to predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 2 patients developed a DLT. There was no further dose escalation when this dose was achieved.
Primary Outcome Measure Information:
Title
Number of Participants with Serious and Non-Serious Adverse Events
Time Frame
Up to 8 weeks
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
Up to 4 months
Title
Time to death
Time Frame
Up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed stage IIIB/IV lung cancer with EGFR mutation
Progressed after platinum-based chemotherapy
The last anti-tumor therapy before entering this study must be gefitinib, erlotinib or icotinib, and the duration for tumor response must be no less than 4 months, or the duration for stable disease must be no less than 6 months
With a measurable disease with conventional CT) according to RECIST Criteria
WHO performance status(PS)<= 2
N>=1.5×109/L, Plt>=1.0×109/L,Hb>=9g/dL; AST&ALT should <2.5ULN(without liver metastasis) or <5ULN(with liver metastasis).TBIL<=1.5ULN.
Signed and dated informed consent before the start of specific protocol procedures.
Exclusion Criteria:
Allergic to icotinib or arsenic trioxide.
Patients with metastatic brain tumors with symptoms.
Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuankai Shi, MD
Phone
0086-13701251865
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saijuan Chen, MD
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuankai Shi, MD
Organizational Affiliation
Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuankai Shi, MD
First Name & Middle Initial & Last Name & Degree
Yuankai Shi, MD
12. IPD Sharing Statement
Learn more about this trial
Icotinib and Arsenic Trioxide in Treating Non-small-cell Lung Cancer Patients With Resistance to EGFR-TKI
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