Trial Outcomes & Findings for Study of Temzolomide and Gleevec in Advanced Melanoma (NCT NCT00667953)

NCT ID: NCT00667953

Last Updated: 2023-03-30

Results Overview

Number of reported grade 3 or 4 adverse events

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 32 participants
• Primary outcome timeframe: through study completion, an average of 1 year
• Results posted on: 2023-03-30

Participant Flow

Participant milestones

Measure	Arm A: Gleevec + Temozolomide: Temzolomide (1000 mg/m2) over 5 days on a 28 day cycle. Gleevec (600 mg) daily.
Overall Study STARTED	32
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Temzolomide and Gleevec in Advanced Melanoma

Baseline characteristics by cohort

Measure	Arm A: n=32 Participants Gleevec + Temozolomide: Temzolomide (1000 mg/m2) over 5 days on a 28 day cycle. Gleevec (600 mg) daily.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants

PRIMARY outcome

Timeframe: through study completion, an average of 1 year

Population: Data from final 4 patients enrolled on study not available

Number of reported grade 3 or 4 adverse events

Outcome measures

Measure	Arm A: n=28 Participants Gleevec + Temozolomide: Temzolomide (1000 mg/m2) over 5 days on a 28 day cycle. Gleevec (600 mg) daily.
Safety - Grade 3 or 4 Adverse Events	20 Adverse Events

SECONDARY outcome

Timeframe: through study completion, an average of 1 year

Population: 4 subjects did not meet physician criteria for response rate, thus their data was unusable

Response rate by RECIST

Outcome measures

Measure	Arm A: n=28 Participants Gleevec + Temozolomide: Temzolomide (1000 mg/m2) over 5 days on a 28 day cycle. Gleevec (600 mg) daily.
Response	1 Participants

SECONDARY outcome

Timeframe: through study completion

Outcome measures

Outcome data not reported

Adverse Events

Arm A:

Serious events: 3 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm A: n=28 participants at risk Gleevec + Temozolomide: Temzolomide (1000 mg/m2) over 5 days on a 28 day cycle. Gleevec (600 mg) daily.
Vascular disorders DVT	3.6% 1/28 • Number of events 1 • through study completion, an average of 1 year
Cardiac disorders Pericardial effusion	3.6% 1/28 • Number of events 1 • through study completion, an average of 1 year
Respiratory, thoracic and mediastinal disorders Hemothorax	3.6% 1/28 • Number of events 1 • through study completion, an average of 1 year

Other adverse events

Measure	Arm A: n=28 participants at risk Gleevec + Temozolomide: Temzolomide (1000 mg/m2) over 5 days on a 28 day cycle. Gleevec (600 mg) daily.
General disorders Fatigue	57.1% 16/28 • Number of events 16 • through study completion, an average of 1 year
Blood and lymphatic system disorders Thrombocytopenia	25.0% 7/28 • Number of events 7 • through study completion, an average of 1 year
Blood and lymphatic system disorders Anemia	28.6% 8/28 • Number of events 8 • through study completion, an average of 1 year
Gastrointestinal disorders Diarrhea	35.7% 10/28 • Number of events 10 • through study completion, an average of 1 year

Additional Information

Tara C Mitchell

Penn

Phone: 215-662-4000

Email: Tara.Mitchell@pennmedicine.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place