Self EfficacyPhase 2NCT01965275
High-Dose,Pulsatile Erlotinib/Gefitinib for Advanced NSCLC Patients After Failure of Standard Dose EGFR-TKIs
A Phase 2 study testing Erlotinib or Gefitinib in people with Self Efficacy and Drug Toxicity, run by Anhui Medical University at 1 site in China.
Trial summary
the purpose of this study is to evaluate the efficacy and safety of high-dose，pulsatile Erlotinib/Gefitinib in advanced non small cell lung cancer (NSCLC) patients after failure of standard dose EGFR-TKIs（Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors） Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Self Efficacy, Drug Toxicity
- What is being tested?
- Erlotinib or Gefitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Dec 2017
- Phase
- Phase 2
- 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
- 1. NSCLC patients were confirmed by histology or cytology 2. Patients were ever treated with standard dose EGFR-TKIs(Erlotinib or Gefitinib )on which he/she achieved complete remission/partial remission,or maintained stable disease for 4 months.Disease progression at present (accord to RECISTv1.1 criteria） 3.At least one target lesion that has not previously been radiated and is measurable according to RECIST v1.1; 4.Have an ECOG PS of 0-2 5.At least 8 weeks of expected survival time 6.Have no serious cardiovascular,hepatobiliary or renal disorders 7.Provision of a voluntarily given, personally signed and dated, written informed consent document 8.Must be in accordance with the following laboratory biochemical data: Hgb≥80g/L，WBC≥3.0×10^9/L，ANC≥1.0×10^9/L， PLT≥80×10^9/L Renal function：SCr≤ULN Liver function： if no hepatic metastases:AST/ALT≤2.5ULN if hepatic metastases:AST/ALT≤5ULN
Who cannot join
- If the subject meet any of the following exclusion criteria ,he/she is no eligible to participate in this study
- Have chronic toxicity reaction(above grade 2) and not recovered( hair loss not include)
- Have Appeared skin rashes or diarrhea(above grade 3),or have any reason lead to decrement during standard dose EGFR-TKIs treatment
- Female subjects who are in pregnancy or lactation，or of childbearing age but don't take any contraceptive measures
- Current enrollment in another therapeutic clinical study
- Have any symptoms of brain metastases or leptomeningeal metastases
- Subjects will not be eligible if they have history of prior malignancy in past 5 years
- Any psychiatric or cognitive disorder that would limit the understanding or rendering of informed consent and/or compromise compliance with the requirements of this study or known drug abuse/alcohol abuse.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dept. of Oncology,The First Affiliated Hospital of Anhui Medical Univesrsity
Hefei, Anhui, 230032
Yanzhe Zhu, MD, 8655162922987, yanzhe918@163.com
Yueyin Pan, MD
About this study
Official title: An Open,Multi Center Trial to Evaluate the Efficacy and Safety of High-Dose,Pulsatile Erlotinib/Gefitinib for Advanced Non-Small Cell Lung Cancer Patients After Failure of Standard Dose EGFR-TKIs
the purpose of this study is to evaluate the efficacy and safety of high-dose，pulsatile Erlotinib/Gefitinib in advanced non small cell lung cancer (NSCLC) patients after failure of standard dose EGFR-TKIs（Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors）
Read the detailed description
To evaluate the efficacy and safety by treating the advanced non small cell lung cancer (NSCLC) patients who have failure of standard dose EGFR-TKIs(Erlotinib or Gefitinib ) with high-dose, pulsatile Erlotinib(450mg every 3 days) or Gefitinib (1000mg every 4 days)
- Conditions
- Self Efficacy, Drug Toxicity
- Being tested
- Erlotinib or Gefitinib
- Keywords
- Advanced non-small cell lung cancer, High-dose, Pulsatile, EGFR-TKIs
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erlotinib or GefitinibDrug
Also called high-dose, pulsatile Erlotinib or Gefitinib
Patients received the treatment with high-dose, pulsatile Erlotinib(600 mg every 4 days) or Gefitinib (1000 mg every 4 days) until disease progression or unacceptable toxicity occurred. The overall study period takes about 12 months
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib or Gefitinib | Experimental | Patients received the treatment with high-dose, pulsatile Erlotinib(600 mg every 4 days) or Gefitinib (1000 mg every 4 days) until disease progression or unacceptable toxicity occurred. The overall study period takes about 12 months Receives: Drug: Erlotinib or Gefitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy and safety
To evaluate the efficacy and safety by treating the advanced NSCLC patients who have failure of standard dose EGFR-TKIs with high-dose, pulsatile Erlotinib(600mg every 4 days) or Gefitinib (1000mg every 4 days)
Radiologically measurable disease by RECIST v1.1 criteria:
- At least one target lesion that has not previously been radiated and is measurable according to RECIST v1.1;
- Acceptable radiologic procedures for disease assessment include contrast enhanced conventional or spiral computed tomography (CT), or contrast enhanced magnetic resonance imaging (MRI); Non-contrast CT scan is acceptable only for subjects who are both allergic to intravenous contrast and unable to cooperate with MRI, or MRI is not available. The following are not allowed as sole documentation of target lesions: CT component of a positron emission tomography (PET)/CT,ultrasound alone, nuclear scans (including bone or PET scans), chest X-ray or bone radiographs, and tumor markers
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self EfficacyStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan Yueyin, Anhui Medical University
- Investigators
- Yueyin Pan, PHD,MD, Principal investigator, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965275
- Sponsor's protocol ID
- HDP-ADNSCLC
- Status last verified
- May 2017
- First submitted
- 10 Oct 2013
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open,Multi Center Trial to Evaluate the Efficacy and Safety of High-Dose,Pulsatile Erlotinib/Gefitinib for Advanced Non-Small Cell Lung Cancer Patients After Failure of Standard Dose EGFR-TKIs
- ClinicalTrials.gov ID
- NCT01965275
- Acronym / sponsor ID
- HDP-ADNSCLC
- Conditions
- Self Efficacy, Drug Toxicity
- Keywords
- Advanced non-small cell lung cancer, High-dose, Pulsatile, EGFR-TKIs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 18 Oct 2013 (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 purpose of this study is to evaluate the efficacy and safety of high-dose，pulsatile Erlotinib/Gefitinib in advanced non small cell lung cancer (NSCLC) patients after failure of standard dose EGFR-TKIs（Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors）
Detailed description
To evaluate the efficacy and safety by treating the advanced non small cell lung cancer (NSCLC) patients who have failure of standard dose EGFR-TKIs(Erlotinib or Gefitinib ) with high-dose, pulsatile Erlotinib(450mg every 3 days) or Gefitinib (1000mg every 4 days)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erlotinib or Gefitinib | Experimental | Drug: Erlotinib or GefitinibPatients received the treatment with high-dose, pulsatile Erlotinib(600 mg every 4 days) or Gefitinib (1000 mg every 4 days) until disease progression or unacceptable toxicity occurred. The overall study period takes about 12 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. NSCLC patients were confirmed by histology or cytology 2. Patients were ever treated with standard dose EGFR-TKIs(Erlotinib or Gefitinib )on which he/she achieved complete remission/partial remission,or maintained stable disease for 4 months.Disease progression at present (accord to RECISTv1.1 criteria） 3.At least one target lesion that has not previously been radiated and is measurable according to RECIST v1.1; 4.Have an ECOG PS of 0-2 5.At least 8 weeks of expected survival time 6.Have no serious cardiovascular,hepatobiliary or renal disorders 7.Provision of a voluntarily given, personally signed and dated, written informed consent document 8.Must be in accordance with the following laboratory biochemical data: Hgb≥80g/L，WBC≥3.0×10^9/L，ANC≥1.0×10^9/L， PLT≥80×10^9/L Renal function：SCr≤ULN Liver function： if no hepatic metastases:AST/ALT≤2.5ULN if hepatic metastases:AST/ALT≤5ULN
Key exclusion criteria (8 listed)
- If the subject meet any of the following exclusion criteria ,he/she is no eligible to participate in this study
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 |
|---|---|---|
| Erlotinib or GefitinibAlso: high-dose, pulsatile Erlotinib or GefitinibPatients received the treatment with high-dose, pulsatile Erlotinib(600 mg every 4 days) or Gefitinib (1000 mg every 4 days) until disease progression or unacceptable toxicity occurred. The overall study period takes about 12 months | Drug | Erlotinib or Gefitinib |
Primary outcome
efficacy and safety
Time frame: 1 year
To evaluate the efficacy and safety by treating the advanced NSCLC patients who have failure of standard dose EGFR-TKIs with high-dose, pulsatile Erlotinib(600mg every 4 days) or Gefitinib (1000mg every 4 days) Radiologically measurable disease by RECIST v1.1 criteria: 1. At least one target lesion that has not previously been radiated and is measurable according to RECIST v1.1; 2. Acceptable radiologic procedures for disease assessment include contrast enhanced conventional or spiral computed tomography (CT), or contrast enhanced magnetic resonance imaging (MRI); Non-contrast CT scan is acceptable only for subjects who are both allergic to intravenous contrast and unable to cooperate with MRI, or MRI is not available. The following are not allowed as sole documentation of target lesions: CT component of a positron emission tomography (PET)/CT,ultrasound alone, nuclear scans (including bone or PET scans), chest X-ray or bone radiographs, and tumor markers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
Yueyin Pan, PHD,MD principal investigator
Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erlotinib or Gefitinib in people with Self Efficacy and Drug Toxicity, run by Anhui Medical University 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 1 inclusion and 8 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 8 May 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yanzhe Zhu, MD (8655162922987, yanzhe918@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy and safety (time frame: 1 year). 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 8 May 2017.