Trial Outcomes & Findings for Saracatinib in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery (NCT NCT00669019)

Last Updated: 2014-05-21

Results Overview

Response will be evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST). A sum of the longest diameter (LD) for all target lesions will be calculated and reported as the baseline sum LD. The baseline sum LD will be used as reference by which to characterize the objective tumor response. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum LD; Objective response = CR + PR. CT scans will be performed at baseline and every 4-8 weeks while on study.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Up to 25 weeks

Results posted on

2014-05-21

Participant Flow

Patients were enrolled at five sites in the United States between August 2008 and September 2009.

Participant milestones

Participant milestones
Measure	Saracatinib Patients receive saracatinib 175 mg oral, once daily in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	23
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Saracatinib in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Saracatinib n=23 Participants Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
Age, Continuous	63 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants
Performance Status 0	13 participants n=5 Participants
Performance Status 1	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 25 weeks

Outcome measures

Outcome measures
Measure	Saracatinib n=23 Participants Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
Objective Response Rate	0 percentage of participants Interval 0.0 to 14.8

SECONDARY outcome

Timeframe: Up to 2 years

Progression will be evaluated in this study using the RECIST criteria (the appearance of new lesions and/or at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study). Progression-free survival time was calculated as the time from treatment start to date of progression or death, whichever comes first.

Outcome measures

Outcome measures
Measure	Saracatinib n=23 Participants Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
Progression-free Survival	7.4 weeks Interval 7.0 to 7.9

Adverse Events

Saracatinib

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Saracatinib n=23 participants at risk Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
Investigations Creatinine increased	4.3% 1/23 • Adverse events were monitored over the course of treatment treatment related adverse events are reported

Other adverse events

Other adverse events
Measure	Saracatinib n=23 participants at risk Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
General disorders Fatigue	82.6% 19/23 • Adverse events were monitored over the course of treatment treatment related adverse events are reported
Metabolism and nutrition disorders Hyperglycemia	73.9% 17/23 • Adverse events were monitored over the course of treatment treatment related adverse events are reported
Blood and lymphatic system disorders Anemia	65.2% 15/23 • Adverse events were monitored over the course of treatment treatment related adverse events are reported
Gastrointestinal disorders Diarrhea	56.5% 13/23 • Adverse events were monitored over the course of treatment treatment related adverse events are reported
Metabolism and nutrition disorders Anorexia	47.8% 11/23 • Adverse events were monitored over the course of treatment treatment related adverse events are reported
Metabolism and nutrition disorders Hypocalcemia	43.5% 10/23 • Adverse events were monitored over the course of treatment treatment related adverse events are reported
Gastrointestinal disorders Nausea	47.8% 11/23 • Adverse events were monitored over the course of treatment treatment related adverse events are reported
Metabolism and nutrition disorders Hyponatremia	39.1% 9/23 • Adverse events were monitored over the course of treatment treatment related adverse events are reported
Investigations Aspartate aminotransferase increased	30.4% 7/23 • Adverse events were monitored over the course of treatment treatment related adverse events are reported
Gastrointestinal disorders Vomiting	21.7% 5/23 • Adverse events were monitored over the course of treatment treatment related adverse events are reported
Investigations Platelet count decreased	21.7% 5/23 • Adverse events were monitored over the course of treatment treatment related adverse events are reported
Investigations Lymphocyte count decreased	30.4% 7/23 • Adverse events were monitored over the course of treatment treatment related adverse events are reported

Additional Information

Dr. Thomas F. Gajewski

University of Chicago

Phone: 773-702-4601

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60