Carcinoma, Non-small Cell LungPhase 2NCT01514864
Trial of Dasatinib in Patients With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation
A Phase 2 study testing Dasatinib in people with Carcinoma, Non-small Cell Lung, run by Bristol-Myers Squibb at 24 sites in 7 countries.
Trial summary
The purpose of this study is to establish whether patients with malignancy harboring a discoidin domain receptor 2 mutation or an inactivating B-RAF mutation will respond to dasatinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-small Cell Lung
- What is being tested?
- Dasatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 24 sitesin 7 countries
- Study dates
- 31 May 2012to 23 Jul 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of advanced malignancy, nonsmall-cell lung cancer (NSCLC) only during stage 1 of accrual.
- Nonsynonymous mutation of B-RAF or DDR2, defined as follows:.
- NSCLC with inactivating B-RAF mutation.
- NSCLC with discoidin domain receptor 2 (DDR2) mutation.
- Malignancy of other histology with DDR2 mutation or inactivating B-RAF mutation, or NSCLC having a B-RAF mutation that is not functionally characterized.
- At least 1 target lesion per Response Evaluation Criteria in Solid Tumors, vol 1.1, on baseline staging evaluation.
- Disease progression after ≥ 1 prior treatment regimen.
Who cannot join
- Pleural or pericardial effusion, Grade >1.
- QTcF >470 msec (Grade ≥2) or diagnosed congenital long QT syndrome.
- Absolute granulocyte count <1500/mm^3.
- Hemoglobin level <10 g/dL.
- Platelet count < 75,000/mm^3.
- Serum calcium level <institutional lower limit of normal.
Show all 11Show fewer
- Hypokalemia, hypophosphatemia, or hypomagnesemia, Grade >1, despite supplementation.
- Creatinine >3*institutional upper limit of normal (ULN).
- Total bilirubin level >1.5*ULN.
- Alanine transaminase level >3*ULN.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
24 sites in 7 countries.
24 sites in 7 countries
United Kingdom7 sites
Local Institution
Cambridge, Cambridgeshire, CB2 2QQ
Local Institution
Cambridge, CB2 2QQ
Local Institution
Edinburgh, Midlothian, EH4 2XU
Local Institution
Gwent, Gwent, NP20 2UB
Local Institution
London, Greater London, SW3 6JJ
Local Institution
Manchester, Greater Manchester, M20 4BX
Local Institution
Sutton, Surrey, SM2 5PT
Germany5 sites
Local Institution
Cologne, 50924
Local Institution
Cologne, 50931
Local Institution
Frankfurt, 60488
Local Institution
Heidelberg, 69120
Local Institution
Heidelberg, 69126
Brazil4 sites
Local Institution
Barretos, São Paulo, 14784-400
Local Institution
Barretos, São Paulo, 14784
Local Institution
S?o Paulo, São Paulo, 05403
Local Institution
São Paulo, 01246-000
United States3 sites
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau
New York, New York, 10065
H. Lee Moffitt Cancer & Research Institute
Tampa, Florida, 33612
Poland3 sites
Local Institution
Gdansk, 80-219
Local Institution
Lodz, 93-509
Local Institution
Warsaw, 02-781
About this study
Official title: Phase II Trial of Dasatinib in Subjects With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation
The purpose of this study is to establish whether patients with malignancy harboring a discoidin domain receptor 2 mutation or an inactivating B-RAF mutation will respond to dasatinib.
- Conditions
- Carcinoma, Non-small Cell Lung
- Being tested
- Dasatinib
- 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.
DasatinibDrug
Tablet, oral, 140 mg, once daily until unacceptable toxicity or disease progression
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation) | Experimental | Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred Receives: Drug: Dasatinib |
| Dasatinib, 140 mg (NSCLC With DDR2 Mutation) | Experimental | Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred Receives: Drug: Dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR is defined as the percentage of patients with best tumor response of either Partial Response (a 30% or greater decrease in the sum of the longest diameter [LD] of all lesions in reference to the baseline sum LD) or Complete Response (disappearance of clinical and radiologic evidence of target lesions), according to Response Evaluation Criteria in Solid Tumors.
Measured: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first
Secondary outcomes (6)
Duration of Response (DOR)
DOR is defined as the time from the first assessment documentation of partial response (PR) or complete response (CR) until the first assessment documentation of disease progression.
Measured: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first
Overall Survival
Overall survival is defined as the time from treatment start date to the date of death. If a patient does not die, survival will be censored on the last date the patient was known to be alive.
Measured: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first
Progression-free Survival (PFS) Distribution
PFS distribution is defined as the percentage of patients with no documentation of disease progression at a specified time point. Confidence interval computed using the Brookmeyer and Crowley method
Measured: From Day 1 of study treatment to Week 12
Progression-free Survival (PFS)
PFS is defined as the time from treatment start date to the earliest evidence of disease progression or death. Patients who die or whose disease does not progress will be censored on the date of their last tumor assessment.
Measured: From Day 1 of study treatment to Week 12
Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or unknown relationship to study drug.
Measured: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first
Number of Participants With Laboratory Testing Results That Meet the Criteria for Grade 3 or 4 Abnormality
Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to adverse event. Laboratory values graded by Common Terminology Criteria for Adverse Events, volume 3. Hemoglobin, Grade 3: <8.0 - 6.5 g/dL, <4.9-4.0 mmol/L, <80-65 g/L. Alkaline phosphatase, Grade 3: >5.0-20.0*upper limit of normal (ULN). Total bilirubin, Grade 3: >3.0-10.0*ULN. Calcium, low, Grade 3: <7.0-6.0 mg/dL, <1.75-1.5 mmol/L.
Measured: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study start31 May 2012
- Primary completion23 Jul 2014
- Study completion23 Jul 2014
Why it stopped: Lack of efficacy and slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, Non-small Cell LungStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514864
- Sponsor's protocol ID
- CA180-385
- Other IDs
- 2011-003128-11
- Status last verified
- Dec 2023
- First submitted
- 18 Jan 2012
- Last updated
- 19 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Dasatinib in Subjects With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation
- ClinicalTrials.gov ID
- NCT01514864
- Acronym / sponsor ID
- CA180-385
- Conditions
- Carcinoma, Non-small Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy and slow accrual
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 31 May 2012 (actual)
- Primary completion
- 23 Jul 2014 (actual)
- Study completion
- 23 Jul 2014 (actual)
- First posted
- 23 Jan 2012 (estimated)
- Results
- Posted 3 Dec 2015
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 establish whether patients with malignancy harboring a discoidin domain receptor 2 mutation or an inactivating B-RAF mutation will respond to dasatinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation) | Experimental | Drug: DasatinibParticipants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred |
| Dasatinib, 140 mg (NSCLC With DDR2 Mutation) | Experimental | Drug: DasatinibParticipants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of advanced malignancy, nonsmall-cell lung cancer (NSCLC) only during stage 1 of accrual.
- Nonsynonymous mutation of B-RAF or DDR2, defined as follows:.
- NSCLC with discoidin domain receptor 2 (DDR2) mutation.
- Malignancy of other histology with DDR2 mutation or inactivating B-RAF mutation, or NSCLC having a B-RAF mutation that is not functionally characterized.
- At least 1 target lesion per Response Evaluation Criteria in Solid Tumors, vol 1.1, on baseline staging evaluation.
Key exclusion criteria (11 listed)
- Pleural or pericardial effusion, Grade >1.
- QTcF >470 msec (Grade ≥2) or diagnosed congenital long QT syndrome.
- Absolute granulocyte count <1500/mm^3.
- Hemoglobin level <10 g/dL.
- Platelet count < 75,000/mm^3.
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 |
|---|---|---|
| DasatinibTablet, oral, 140 mg, once daily until unacceptable toxicity or disease progression | Drug | Dasatinib, 140 mg (NSCLC With DDR2 Mutation), Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation) |
Primary outcome
Objective Response Rate (ORR)
Time frame: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first
ORR is defined as the percentage of patients with best tumor response of either Partial Response (a 30% or greater decrease in the sum of the longest diameter [LD] of all lesions in reference to the baseline sum LD) or Complete Response (disappearance of clinical and radiologic evidence of target lesions), according to Response Evaluation Criteria in Solid Tumors.
6 secondary outcomes
Duration of Response (DOR)
Time frame: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first
Overall Survival
Time frame: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first
Progression-free Survival (PFS) Distribution
Time frame: From Day 1 of study treatment to Week 12
Progression-free Survival (PFS)
Time frame: From Day 1 of study treatment to Week 12
Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation
Time frame: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first
Number of Participants With Laboratory Testing Results That Meet the Criteria for Grade 3 or 4 Abnormality
Time frame: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
24 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasatinib in people with Carcinoma, Non-small Cell Lung, run by Bristol-Myers Squibb at 24 sites in 7 countries.
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 11 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: stopped early, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United Kingdom, Germany, Brazil, United States, Poland and 2 more countries. 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?
Yes. Results are posted in the registry (first posted 3 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Objective Response Rate (ORR) (time frame: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first). 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 19 Dec 2023.