ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of Dasatinib in Patients With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01514864
Recruitment Status : Terminated (Lack of efficacy and slow accrual)
First Posted : January 23, 2012
Results First Posted : December 3, 2015
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Carcinoma, Non-small Cell Lung
Intervention: Drug: Dasatinib

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 19 patients were enrolled, and 14 received treatment in 2 cohorts: 9 with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation and 5 with NSCLC and a discoidin domain receptor 2 (DDR2) mutation.

Reporting Groups
  Description
Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation) 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
Dasatinib, 140 mg (NSCLC With DDR2 Mutation) 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

Participant Flow:   Overall Study
    Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)   Dasatinib, 140 mg (NSCLC With DDR2 Mutation)
STARTED   9   5 
COMPLETED   0 [1]   0 
NOT COMPLETED   9   5 
Disease progression                7                5 
Study drug toxicity                2                0 
[1] Study was terminated; no patients completed study treatment



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 dose of study drug

Reporting Groups
  Description
Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation) 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
Dasatinib, 140 mg (NSCLC With DDR2 Mutation) 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
Total Total of all reporting groups

Baseline Measures
   Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)   Dasatinib, 140 mg (NSCLC With DDR2 Mutation)   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   5   14 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   3   3   6 
>=65 years   6   2   8 
Age 
[Units: Years]
Median (Full Range)
 67.0 
 (51.0 to 75.0) 
 63.0 
 (50.0 to 73.0) 
 66.5 
 (50.0 to 75.0) 
Gender 
[Units: Participants]
     
Female   5   1   6 
Male   4   4   8 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   1   0   1 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   0   1   1 
White   8   4   12 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
Hispanic/Latino   1   0   1 
Not Hispanic/Latino   5   5   10 
Not reported   3   0   3 
Time from cancer diagnosis to start of study therapy 
[Units: Months]
Median (Full Range)
 14.4 
 (6.2 to 21.7) 
 8.5 
 (1.5 to 51.6) 
 12.1 
 (1.5 to 51.6) 
Tumor Type 
[Units: Participants]
     
Nonsmall-cell lung carcinoma   9   5   14 
Other   0   0   0 
Nonsmall-cell lung carcinoma histology 
[Units: Participants]
     
Adenocarcinoma   7   1   8 
Bronco-alveolar carcinoma   1   0   1 
Large cell carcinoma   1   0   1 
Squamous cell carcinoma   0   4   4 
Histopathologic Grade 
[Units: Participants]
     
G2-moderately differentiated   2   2   4 
G3-poorly differentiated   2   0   2 
GX-grade cannot be assessed   5   3   8 
Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status [1] 
[Units: Participants]
     
ECOG score 0   1   1   2 
ECOG score 1   6   3   9 
ECOG score 2   2   1   3 
[1] ECOG is a 6-item scale used to assess disease progression, daily functioning, and appropriate treatment and prognosis. Performance status is scored on a scale ranging from 0-5, with (best score) 0=fully active and able to carry on all predisease performance without restriction and (worst score) 5=death.
Number of Index Lesions 
[Units: Participants]
     
 2   1   3 
 0   2   2 
 4   1   5 
 3   1   4 


  Outcome Measures

1.  Primary:   Objective Response Rate (ORR)   [ Time Frame: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first ]

2.  Secondary:   Duration of Response (DOR)   [ Time Frame: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first ]

3.  Secondary:   Overall Survival   [ Time Frame: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first ]

4.  Secondary:   Progression-free Survival (PFS) Distribution   [ Time Frame: From Day 1 of study treatment to Week 12 ]

5.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: From Day 1 of study treatment to Week 12 ]

6.  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   [ Time Frame: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first ]

7.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was terminated due to lack of efficacy and slow enrollment of patients.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com



Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01514864     History of Changes
Other Study ID Numbers: CA180-385
2011-003128-11 ( EudraCT Number )
First Submitted: January 18, 2012
First Posted: January 23, 2012
Results First Submitted: July 23, 2015
Results First Posted: December 3, 2015
Last Update Posted: December 3, 2015