Non-small Cell Lung CancerPhase 1NCT02066870
Icotinib and Arsenic Trioxide in Treating Non-small-cell Lung Cancer Patients With Resistance to EGFR-TKI
A Phase 1 study testing Icotinib and Arsenic trioxide in people with Non-small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Icotinib and Arsenic trioxide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Jan 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Yuankai Shi, MD contact
China1 site, 1 recruiting
- Recruiting
Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing
Yuankai Shi, MD
Yuankai Shi, MD
About this study
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
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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Icotinib, Arsenic trioxide
- Keywords
- Icotinib, Arsenic Trioxide, Resistance, Non-small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcotinibDrug
Also called BPI-9000, Commana
Icotinib is administered orally 125 mg three times per day, until disease progression or untolerated toxicity.
Arsenic trioxideDrug
Also called Arsenic trioxide for injection
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Icotinib; Drug: Arsenic trioxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Serious and Non-Serious Adverse Events
Measured: Up to 8 weeks
Secondary outcomes (2)
Progression-free survival
Measured: Up to 4 months
Time to death
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionSep 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Betta Pharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Saijuan Chen, MD, Principal investigator, Ruijin HospitalYuankai Shi, MD, Principal investigator, Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066870
- Sponsor's protocol ID
- BD-IC-IV55
- Status last verified
- Mar 2015
- First submitted
- 17 Feb 2014
- Last updated
- 13 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02066870
- Acronym / sponsor ID
- BD-IC-IV55
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Icotinib, Arsenic Trioxide, Resistance, Non-small cell lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 20 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Icotinib and arsenic trioxide | Experimental | Drug: Icotinib, Drug: Arsenic trioxideIcotinib 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IcotinibAlso: BPI-9000, CommanaIcotinib is administered orally 125 mg three times per day, until disease progression or untolerated toxicity. | Drug | Icotinib and arsenic trioxide |
| Arsenic trioxideAlso: Arsenic trioxide for injectionArsenic 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 | Icotinib and arsenic trioxide |
Primary outcome
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: Up to 8 weeks
2 secondary outcomes
Progression-free survival
Time frame: Up to 4 months
Time to death
Time frame: Up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuankai Shi, MD contact
Saijuan Chen, MD principal investigator
Ruijin Hospital
Yuankai Shi, MD principal investigator
Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Icotinib and Arsenic trioxide in people with Non-small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuankai Shi, MD (0086-13701251865), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Serious and Non-Serious Adverse Events (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2015.