NCT02066870

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for phase_1 nonsmall-cell-lung-cancer

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_1 nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 13, 2015

Status Verified

March 1, 2015

Enrollment Period

1.7 years

First QC Date

February 17, 2014

Last Update Submit

March 12, 2015

Conditions

Non-small Cell Lung Cancer

Keywords

IcotinibArsenic TrioxideResistanceNon-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Serious and Non-Serious Adverse Events

    Up to 8 weeks

Secondary Outcomes (2)

  • Progression-free survival

    Up to 4 months

  • Time to death

    Up to 24 months

Study Arms (1)

Icotinib and arsenic trioxide

EXPERIMENTAL

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.

Drug: IcotinibDrug: Arsenic trioxide

Interventions

IcotinibDRUG

Icotinib is administered orally 125 mg three times per day, until disease progression or untolerated toxicity.

Also known as: BPI-9000, Commana
Icotinib and arsenic trioxide
Arsenic trioxideDRUG

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.

Also known as: Arsenic trioxide for injection
Icotinib and arsenic trioxide

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

icotinibArsenic TrioxideInjections

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ArsenicalsInorganic ChemicalsOxidesOxygen CompoundsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Saijuan Chen, MD

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

  • Yuankai Shi, MD

    Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuankai Shi, MD

CONTACT

0086-13701251865

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2014

First Posted

February 20, 2014

Study Start

January 1, 2014

Primary Completion

September 1, 2015

Study Completion

January 1, 2016

Last Updated

March 13, 2015

Record last verified: 2015-03

Locations

CN(1)