Trial Outcomes & Findings for Trial of Tasigna (Nilotinib) 400 mg Twice Daily Alone or With Gleevec (Imatinib Mesylate) 400 mg Daily for Patients With Advanced Gastrointestinal Stromal Tumor (GIST) (NCT NCT01089595)

Results Overview

Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression. It will be determined for both RECIST (Response Evaluation Criteria in Solid Tumors) and CHOI criteria.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

6 months until death or for 5 years

Results posted on

2017-03-15

Participant Flow

During the period of February 2, 2009 through May 26, 2011, recruitment occur at oncology hospital.

Participant milestones

Participant milestones
Measure	Nilotinib Nilotinib 400 mg po bid	Nilotinib + Imatinib Nilotinib 400 mg BID with Imatinib 400 mg daily
Overall Study STARTED	2	3
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of Tasigna (Nilotinib) 400 mg Twice Daily Alone or With Gleevec (Imatinib Mesylate) 400 mg Daily for Patients With Advanced Gastrointestinal Stromal Tumor (GIST)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nilotinib n=2 Participants Nilotinib 400 mg po bid	Nilotinib + Imatinib n=3 Participants Nilotinib 400 mg BID with Imatinib 400 mg daily	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months until death or for 5 years

Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression. It will be determined for both RECIST (Response Evaluation Criteria in Solid Tumors) and CHOI criteria.

Outcome measures

Outcome measures
Measure	Nilotinib n=2 Participants Nilotinib 400 mg by mouth (PO), twice daily (BID)	Nilotinib + Imatinib n=3 Participants Nilotinib 400 mg twice daily (BID) with Imatinib 400 mg daily
Progression Free Survival	13 weeks Standard Deviation 5.6	16 weeks Standard Deviation 16.3

SECONDARY outcome

Timeframe: Every 8 weeks for up to 5 years

Population: Too few participants to provide meaningful analysis

Outcome measures

Outcome measures
Measure	Nilotinib n=2 Participants Nilotinib 400 mg by mouth (PO), twice daily (BID)	Nilotinib + Imatinib n=3 Participants Nilotinib 400 mg twice daily (BID) with Imatinib 400 mg daily
Best Overall Response Using Response Evaluation Criteria in Solid Tumors, Choi Criteria, and Positron Emission Tomography Imaging Stable Disease	2 Participants	0 Participants
Best Overall Response Using Response Evaluation Criteria in Solid Tumors, Choi Criteria, and Positron Emission Tomography Imaging Partial Response	0 Participants	1 Participants
Best Overall Response Using Response Evaluation Criteria in Solid Tumors, Choi Criteria, and Positron Emission Tomography Imaging Complete Response	0 Participants	0 Participants

Adverse Events

Nilotinib

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Nilotinib + Imatinib

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Nilotinib n=2 participants at risk Nilotinib 400 mg po bid	Nilotinib + Imatinib n=3 participants at risk Nilotinib 400 mg BID with Imatinib 400 mg daily
Gastrointestinal disorders Small bowel obstruction	50.0% 1/2 • Number of events 1	0.00% 0/3
Gastrointestinal disorders Cholangitis	0.00% 0/2	33.3% 1/3 • Number of events 1
Gastrointestinal disorders Dehydration	0.00% 0/2	33.3% 1/3 • Number of events 1
Gastrointestinal disorders Gastroenteritis	0.00% 0/2	33.3% 1/3 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Margaret von Mehren, Principal Investigator

Fox Chase Cancer Center

Phone: 215-728-4300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place