Trial · NCT01514864
Trial of Dasatinib in Patients With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation
NCT01514864, Phase 2, Terminated, Bristol-Myers Squibb; results first posted 2015-12-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial of Dasatinib in Patients With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation. Trials, record NCT01514864. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01514864
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Dasatinib in Patients With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation
- NCT number
- NCT01514864
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Carcinoma, Non-small Cell Lung
- Interventions
- Dasatinib
- First posted
- 2012-01-23
- Last updated
- 2023-12-19
- Other registries' IDs
- eudract:2011-003128-11
- Results first posted
- 2015-12-03
- Limitations and caveats
- The study was terminated due to lack of efficacy and slow enrollment of patients.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | 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. |
| Secondary | Duration of Response (DOR) | From enrollment of last patient to 24 months or until all patients have died, whichever occurs first | 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. |
| Secondary | Overall Survival | From enrollment of last patient to 24 months or until all patients have died, whichever occurs first | 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. |
| Secondary | Progression-free Survival (PFS) Distribution | From Day 1 of study treatment to Week 12 | 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 |
| Secondary | Progression-free Survival (PFS) | From Day 1 of study treatment to Week 12 | 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. |
| Secondary | 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 | From enrollment of last patient to 24 months or until all patients have died, whichever occurs first | 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. |
| Secondary | Number of Participants With Laboratory Testing Results That Meet the Criteria for Grade 3 or 4 Abnormality | From enrollment of last patient to 24 months or until all patients have died, whichever occurs first | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | From enrollment of last patient to 24 months or until all patients have died, whichever occurs first | All participants who received at least 1 dose of study drug. Because no patients had a response of CR or PR, ORR could not be calculated. | ||
| SECONDARY | Duration of Response (DOR) | From enrollment of last patient to 24 months or until all patients have died, whichever occurs first | All participants who received at least 1 dose of study drug. Because no patients had a response of CR or PR, DOR could not be calculated. | ||
| SECONDARY | Overall Survival | From enrollment of last patient to 24 months or until all patients have died, whichever occurs first | All participants who received treatment | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) Distribution | From Day 1 of study treatment to Week 12 | All participants who received at least 1 dose of study drug | Percentage of participants | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | From Day 1 of study treatment to Week 12 | All participants who received at least 1 dose of study drug | Months | MEDIAN |
| SECONDARY | 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 | From enrollment of last patient to 24 months or until all patients have died, whichever occurs first | All participants who received at least 1 dose of study drug | Participants | NUMBER |
| SECONDARY | Number of Participants With Laboratory Testing Results That Meet the Criteria for Grade 3 or 4 Abnormality | From enrollment of last patient to 24 months or until all patients have died, whichever occurs first | All participants who received study drug. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation) | 3.06 | 90% Confidence Interval 0.76 to 6.47 | Months | |
| Overall Survival | Dasatinib, 140 mg (NSCLC With DDR2 Mutation) | 4.21 | 90% Confidence Interval 0.82 to NA | Months | |
| Progression-free Survival (PFS) Distribution | Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation) | 1.41 | 90% Confidence Interval 0.72 to 1.87 | Percentage of participants | |
| Progression-free Survival (PFS) Distribution | Dasatinib, 140 mg (NSCLC With DDR2 Mutation) | 1.38 | 90% Confidence Interval 0.59 to 2.96 | Percentage of participants | |
| Progression-free Survival (PFS) | Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation) | 1.41 | 90% Confidence Interval 0.72 to 1.87 | Months | |
| Progression-free Survival (PFS) | Dasatinib, 140 mg (NSCLC With DDR2 Mutation) | 1.38 | 90% Confidence Interval 0.59 to 2.96 | Months | |
| 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 | Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation) | Death | 8 | Participants | |
| 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 | Dasatinib, 140 mg (NSCLC With DDR2 Mutation) | Death | 4 | Participants | |
| 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 | Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation) | Death within 30 days of last treatment | 3 | Participants | |
| 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 | Dasatinib, 140 mg (NSCLC With DDR2 Mutation) | Death within 30 days of last treatment | 1 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation) | 9 | |
| Overall Study | STARTED | Dasatinib, 140 mg (NSCLC With DDR2 Mutation) | 5 | |
| Overall Study | COMPLETED | Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation) | 0 | |
| Overall Study | COMPLETED | Dasatinib, 140 mg (NSCLC With DDR2 Mutation) | 0 | |
| Overall Study | NOT COMPLETED | Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation) | 9 | |
| Overall Study | NOT COMPLETED | Dasatinib, 140 mg (NSCLC With DDR2 Mutation) | 5 |
Source ClinicalTrials.gov
Adverse events92
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blood alkaline phosphatase increased | Investigations | Dasatinib, 140 mg | 1 | 14 | |
| other | Dry skin | Skin and subcutaneous tissue disorders | Dasatinib, 140 mg | 1 | 14 | |
| other | Hepatic pain | Hepatobiliary disorders | Dasatinib, 140 mg | 1 | 14 | |
| other | Pyrexia | General disorders | Dasatinib, 140 mg | 2 | 14 | |
| other | Sedation | Nervous system disorders | Dasatinib, 140 mg | 1 | 14 | |
| other | Uveitis | Eye disorders | Dasatinib, 140 mg | 1 | 14 | |
| other | Calcium ionised increased | Investigations | Dasatinib, 140 mg | 1 | 14 | |
| other | Diverticular perforation | Gastrointestinal disorders | Dasatinib, 140 mg | 1 | 14 | |
| other | Dizziness | Nervous system disorders | Dasatinib, 140 mg | 1 | 14 | |
| other | Dysgeusia | Nervous system disorders | Dasatinib, 140 mg | 1 | 14 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib, 140 mg | ||
| Total, other adverse events | Dasatinib, 140 mg | 13 | 14 |
| Total, serious adverse events | Dasatinib, 140 mg | 11 | 14 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01514864
GET https://conductscience.org/api/trials/v1/NCT01514864/results?page=2