Non-Small-Cell Lung CarcinomaPhase 2NCT01167244
Trial of BMS-690514 in Non-Small Cell Lung Cancer Subjects Who Have Been Treated With Gefitinib or Erlotinib and Are Genotypically EGFR Mutation Positive or Who Have Had a Prior Response
A Phase 2 study testing BMS-690514 in people with Non-Small-Cell Lung Carcinoma, run by Bristol-Myers Squibb at 4 sites in Japan.
Trial summary
The purpose of this study is to observe an improvement in overall response rate in NSCLC subjects who have been treated with gefitinib or erlotinib and are genotypically EGFR mutation positive or who have had a prior a response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Carcinoma
- What is being tested?
- BMS-690514
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 4 sitesJapan
- Study dates
- Aug 2010to Apr 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent, metastatic or progressive NSCLC without any indication of radiotherapy. Subjects must have:
- Pathologically confirmed NSCLC
- Previously received treatment with single agent Gefitinib or Erlotinib and completed treatment at least 2 weeks prior to study entry
- Any one of the following:
- A tumor that harbors an EGFR mutation
- Objective clinical benefit from treatment with Gefitinib or Erlotinib as defined by either documented and confirmed partial or complete response (RECIST or WHO), or significant and durable (≥ 6 months) clinical benefit (stable disease as defined by RECIST or WHO) Progression of NSCLC while on continuous treatment with gefitinib or erlotinib as noted by CT/MRI increase in disease after having a confirmed partial or complete response or evidence of ≥ 6 months of SD within 3 months of study enrollment
Who cannot join
- Symptomatic brain metastasis
- History of TIA, CVA, or thrombotic/thromboembolic event (within last 6 months)
- History of hemoptysis greater than 10 mL/day within last 30 days
- Uncontrolled or significant cardiovascular disease
- History of uncontrolled diarrhea, Crohn's disease or ulcerative colitis
- Inability to swallow tablets, untreated malabsorption or GI surgery that results in inability to absorb protocol therapy
- Women unwilling to avoid pregnancy or use adequate contraception
- History of allergy or adverse drug reaction to gefitinib or erlotinib
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Local Institution
Kashiwa-Shi, Chiba, 2778577
Local Institution
Koto-Ku, Tokyo, 1358550
Local Institution
Osaka-Sayama-Shi, Osaka, 5898511
Local Institution
Sunto-Gun, Shizuoka, 4118777
About this study
Official title: Phase 2 Trial of BMS-690514 in Non-Small Cell Lung Cancer Subjects Who Have Been Treated With Gefitinib or Erlotinib and Are Genotypically EGFR Mutation Positive or Who Have Had a Prior Response
The purpose of this study is to observe an improvement in overall response rate in NSCLC subjects who have been treated with gefitinib or erlotinib and are genotypically EGFR mutation positive or who have had a prior a response.
- Conditions
- Non-Small-Cell Lung Carcinoma
- Being tested
- BMS-690514
- 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.
BMS-690514Drug
Tablets, Oral, 200 mg, once daily, until disease progression or toxicity
| Study group | Role | What they receive |
|---|---|---|
| BMS-690514 | Experimental | Not described Receives: Drug: BMS-690514 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate objective response rate in NSCLC subjects who have been treated with gefitinib or erlotinib and are genotypically EGFR mutation positive or who have had a prior a response
Measured: Tumor assessment Day 29 and every 8 weeks from Day 1 thereafter until disease progression
To estimate objective response rate in NSCLC subjects who have been treated with gefitinib or erlotinib and are genotypically EGFR mutation positive or who have had a prior a response
Measured: Tumor assesments on Day 29 by CT or MRI
To estimate objective response rate in NSCLC subjects who have been treated with gefitinib or erlotinib and are genotypically EGFR mutation positive or who have had a prior a response
Measured: Tumor assessments every 8 weeks from Day 1 by CT or MRI
Secondary outcomes (4)
To estimate disease control rate and progression free survival in all treated subjects
Measured: Tumor assessment Day 29 and every 8 weeks from Day 1 thereafter until disease progression
To estimate disease control rate and progression free survival in all treated subjects
Measured: Tumor assessment from Day 29
To estimate disease control rate and progression free survival in all treated subjects
Measured: Tumor assessment every 8 weeks from Day 1 until disease progression
To evaluate safety and tolerability of BMS-690514 in all treated subjects
Measured: Average about 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionApr 2011
- Study completionApr 2011
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 CarcinomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167244
- Sponsor's protocol ID
- CA187-020
- Status last verified
- Sep 2015
- First submitted
- 16 Jul 2010
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial of BMS-690514 in Non-Small Cell Lung Cancer Subjects Who Have Been Treated With Gefitinib or Erlotinib and Are Genotypically EGFR Mutation Positive or Who Have Had a Prior Response
- ClinicalTrials.gov ID
- NCT01167244
- Acronym / sponsor ID
- CA187-020
- Conditions
- Non-Small-Cell Lung Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 22 Jul 2010 (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 observe an improvement in overall response rate in NSCLC subjects who have been treated with gefitinib or erlotinib and are genotypically EGFR mutation positive or who have had a prior a response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS-690514 | Experimental | Drug: BMS-690514 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Recurrent, metastatic or progressive NSCLC without any indication of radiotherapy. Subjects must have:
- Pathologically confirmed NSCLC
- Previously received treatment with single agent Gefitinib or Erlotinib and completed treatment at least 2 weeks prior to study entry
- Any one of the following:
- A tumor that harbors an EGFR mutation
Key exclusion criteria (8 listed)
- Symptomatic brain metastasis
- History of TIA, CVA, or thrombotic/thromboembolic event (within last 6 months)
- History of hemoptysis greater than 10 mL/day within last 30 days
- Uncontrolled or significant cardiovascular disease
- History of uncontrolled diarrhea, Crohn's disease or ulcerative colitis
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 |
|---|---|---|
| BMS-690514Tablets, Oral, 200 mg, once daily, until disease progression or toxicity | Drug | BMS-690514 |
Primary outcome
To estimate objective response rate in NSCLC subjects who have been treated with gefitinib or erlotinib and are genotypically EGFR mutation positive or who have had a prior a response
Time frame: Tumor assessment Day 29 and every 8 weeks from Day 1 thereafter until disease progression
To estimate objective response rate in NSCLC subjects who have been treated with gefitinib or erlotinib and are genotypically EGFR mutation positive or who have had a prior a response
Time frame: Tumor assesments on Day 29 by CT or MRI
To estimate objective response rate in NSCLC subjects who have been treated with gefitinib or erlotinib and are genotypically EGFR mutation positive or who have had a prior a response
Time frame: Tumor assessments every 8 weeks from Day 1 by CT or MRI
4 secondary outcomes
To estimate disease control rate and progression free survival in all treated subjects
Time frame: Tumor assessment Day 29 and every 8 weeks from Day 1 thereafter until disease progression
To estimate disease control rate and progression free survival in all treated subjects
Time frame: Tumor assessment from Day 29
To estimate disease control rate and progression free survival in all treated subjects
Time frame: Tumor assessment every 8 weeks from Day 1 until disease progression
To evaluate safety and tolerability of BMS-690514 in all treated subjects
Time frame: Average about 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-690514 in people with Non-Small-Cell Lung Carcinoma, run by Bristol-Myers Squibb at 4 sites in Japan.
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 6 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: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate objective response rate in NSCLC subjects who have been treated with gefitinib or erlotinib and are genotypically EGFR mutation positive or who have had a prior a response (time frame: Tumor assessment Day 29 and every 8 weeks from Day 1 thereafter until disease progression). The study lists 3 primary outcomes in all. 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 12 Oct 2015.