Trial Outcomes & Findings for Treatment With Dasatinib in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged Melanoma (NCT NCT01092728)

Last Updated: 2016-09-05

Results Overview

Biologic response defined as either (complete or partial) metabolic tumor response after 7 days dasatinib treatment by positron emission tomography (PET) scan, \>/= 25% decrease in Fluorodeoxyglucose (FDG) activity on PET without \>15% increase in tumoral Ki-67 expression or \>/=25% decrease in tumoral Ki-67 expression without \>15% increase in FDG activity on PET scan. Complete Metabolic Response (CMR): FDG-avidity all lesions reduced to background FDG-avidity level. Partial Metabolic Response (PMR): \>/=25% decrease in FDG-avidity as represented by change in mean Standardized Uptake Values (SUV) max. SUVmax measured by drawing region of interest slightly outside each lesion corresponding to those on CT image \& adjusted for body weight. Measureable disease by PET scan defined as lesions that can be determined to have FDG-avidity of SUVmax of 3 and 2 x background. PR or CR confirmatory disease assessment performed \>4 weeks (28 days) after criteria for response first met.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

Assessment at 7 Days with confirmatory disease assessment performed no less than 4 weeks (28 days) afterwards

Results posted on

2016-09-05

Participant Flow

Recruitment Period: March 2011 to September 2013. All recruitment was done at The University of Texas (UT) MD Anderson Cancer Center.

A total of 19 participants were enrolled, out of which 18 participants were included in the analysis and 1 participant was a screen failure.

Participant milestones

Participant milestones
Measure	Dasatinib + Completely Resectable Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).	Dasatinib + Unresectable Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
Overall Study STARTED	4	14
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	4	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Dasatinib + Completely Resectable Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).	Dasatinib + Unresectable Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
Overall Study Withdrawal by Subject	2	0
Overall Study Adverse Event	0	1
Overall Study Disease Progression	1	13
Overall Study Prohibited Concomitant Medications	1	0

Baseline Characteristics

Treatment With Dasatinib in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dasatinib + Completely Resectable n=4 Participants Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).	Dasatinib + Unresectable n=14 Participants Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).	Total n=18 Participants Total of all reporting groups
Age, Continuous	76 years n=5 Participants	66 years n=7 Participants	71 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	14 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessment at 7 Days with confirmatory disease assessment performed no less than 4 weeks (28 days) afterwards

Population: Of 4 participants in first arm, none were evaluable for response (1 inevaluable, 2 withdrawals, 1 disease progression); and of the second arm, one was inevaluable (withdrawal).

Outcome measures

Outcome measures
Measure	Dasatinib + Completely Resectable Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).	Dasatinib + Unresectable n=13 Participants Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
Biologic Response Evaluation of Tumors With and Without Resectable Tumors Complete Metabolic Response	—	0 participants
Biologic Response Evaluation of Tumors With and Without Resectable Tumors Partial Metabolic Response	—	1 participants

SECONDARY outcome

Timeframe: Evaluated every 2 cycles (8 weeks) until disease progression or last follow-up, up to two years

Population: None of the participants in the Resectable arm were evaluable, and one participant in the second Unresectable arm was inevaluable due to early departure from study.

Progression-Free Survival (PFS) is defined as the duration of time from start of treatment to date of first evidence of progression or the date of last follow-up for patients who do not progress.

Outcome measures

Outcome measures
Measure	Dasatinib + Completely Resectable Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).	Dasatinib + Unresectable n=13 Participants Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
Progression-Free Survival	—	8.00 Weeks Interval 0.86 to 89.57

Adverse Events

Dasatinib + Completely Resectable

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Dasatinib + Unresectable

Serious events: 4 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dasatinib + Completely Resectable n=4 participants at risk Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).	Dasatinib + Unresectable n=14 participants at risk Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
Gastrointestinal disorders Nausea	0.00% 0/4 • Adverse events (AE)s and Serious Adverse Events (SAE)s were collected throughout the study from informed consent until 30 days after study treatment was discontinued. Overall AE collection period: March 11, 2011 to September 09, 2013.	7.1% 1/14 • Number of events 1 • Adverse events (AE)s and Serious Adverse Events (SAE)s were collected throughout the study from informed consent until 30 days after study treatment was discontinued. Overall AE collection period: March 11, 2011 to September 09, 2013.
Gastrointestinal disorders Abdominal Pain	0.00% 0/4 • Adverse events (AE)s and Serious Adverse Events (SAE)s were collected throughout the study from informed consent until 30 days after study treatment was discontinued. Overall AE collection period: March 11, 2011 to September 09, 2013.	14.3% 2/14 • Number of events 2 • Adverse events (AE)s and Serious Adverse Events (SAE)s were collected throughout the study from informed consent until 30 days after study treatment was discontinued. Overall AE collection period: March 11, 2011 to September 09, 2013.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/4 • Adverse events (AE)s and Serious Adverse Events (SAE)s were collected throughout the study from informed consent until 30 days after study treatment was discontinued. Overall AE collection period: March 11, 2011 to September 09, 2013.	7.1% 1/14 • Number of events 1 • Adverse events (AE)s and Serious Adverse Events (SAE)s were collected throughout the study from informed consent until 30 days after study treatment was discontinued. Overall AE collection period: March 11, 2011 to September 09, 2013.
Gastrointestinal disorders Dehydration	0.00% 0/4 • Adverse events (AE)s and Serious Adverse Events (SAE)s were collected throughout the study from informed consent until 30 days after study treatment was discontinued. Overall AE collection period: March 11, 2011 to September 09, 2013.	7.1% 1/14 • Number of events 1 • Adverse events (AE)s and Serious Adverse Events (SAE)s were collected throughout the study from informed consent until 30 days after study treatment was discontinued. Overall AE collection period: March 11, 2011 to September 09, 2013.
Gastrointestinal disorders Dysphagia	0.00% 0/4 • Adverse events (AE)s and Serious Adverse Events (SAE)s were collected throughout the study from informed consent until 30 days after study treatment was discontinued. Overall AE collection period: March 11, 2011 to September 09, 2013.	7.1% 1/14 • Number of events 1 • Adverse events (AE)s and Serious Adverse Events (SAE)s were collected throughout the study from informed consent until 30 days after study treatment was discontinued. Overall AE collection period: March 11, 2011 to September 09, 2013.
General disorders Fatigue	0.00% 0/4 • Adverse events (AE)s and Serious Adverse Events (SAE)s were collected throughout the study from informed consent until 30 days after study treatment was discontinued. Overall AE collection period: March 11, 2011 to September 09, 2013.	7.1% 1/14 • Number of events 1 • Adverse events (AE)s and Serious Adverse Events (SAE)s were collected throughout the study from informed consent until 30 days after study treatment was discontinued. Overall AE collection period: March 11, 2011 to September 09, 2013.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/4 • Adverse events (AE)s and Serious Adverse Events (SAE)s were collected throughout the study from informed consent until 30 days after study treatment was discontinued. Overall AE collection period: March 11, 2011 to September 09, 2013.	7.1% 1/14 • Number of events 1 • Adverse events (AE)s and Serious Adverse Events (SAE)s were collected throughout the study from informed consent until 30 days after study treatment was discontinued. Overall AE collection period: March 11, 2011 to September 09, 2013.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/4 • Adverse events (AE)s and Serious Adverse Events (SAE)s were collected throughout the study from informed consent until 30 days after study treatment was discontinued. Overall AE collection period: March 11, 2011 to September 09, 2013.	14.3% 2/14 • Number of events 2 • Adverse events (AE)s and Serious Adverse Events (SAE)s were collected throughout the study from informed consent until 30 days after study treatment was discontinued. Overall AE collection period: March 11, 2011 to September 09, 2013.
Gastrointestinal disorders Diarrhea	0.00% 0/4 • Adverse events (AE)s and Serious Adverse Events (SAE)s were collected throughout the study from informed consent until 30 days after study treatment was discontinued. Overall AE collection period: March 11, 2011 to September 09, 2013.	7.1% 1/14 • Number of events 1 • Adverse events (AE)s and Serious Adverse Events (SAE)s were collected throughout the study from informed consent until 30 days after study treatment was discontinued. Overall AE collection period: March 11, 2011 to September 09, 2013.
Gastrointestinal disorders Ascites	0.00% 0/4 • Adverse events (AE)s and Serious Adverse Events (SAE)s were collected throughout the study from informed consent until 30 days after study treatment was discontinued. Overall AE collection period: March 11, 2011 to September 09, 2013.	7.1% 1/14 • Number of events 1 • Adverse events (AE)s and Serious Adverse Events (SAE)s were collected throughout the study from informed consent until 30 days after study treatment was discontinued. Overall AE collection period: March 11, 2011 to September 09, 2013.

Other adverse events

Additional Information

Kevin Kim, MD/Melanoma Medical Oncology

The University of Texas (UT) MD Anderson Cancer Center

Phone: 1-877-MDA-6789

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place