Trial Outcomes & Findings for Dasatinib in Treating Patients With Unresectable or Metastatic Squamous Cell Skin Cancer or RAI Stage 0-I Chronic Lymphocytic Leukemia (NCT NCT00563290)

Last Updated: 2015-06-18

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Every 2 courses during treatment, assessed up to 12 weeks after completion of treatment

Results posted on

2015-06-18

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I Dasatinib Patients receive 100 mg orally twice a day.	Arm II Dasatinib Patients receive 70 mg dasatinib PO BID on days 1-28
Overall Study STARTED	3	4
Overall Study COMPLETED	3	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dasatinib in Treating Patients With Unresectable or Metastatic Squamous Cell Skin Cancer or RAI Stage 0-I Chronic Lymphocytic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I Dasatinib n=3 Participants Patients receive oral dasatinib 100 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm II Dastinib n=4 Participants Patients receive oral dasatinib 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Total n=7 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	4 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Every 2 courses during treatment, assessed up to 12 weeks after completion of treatment

Outcome measures

Outcome measures
Measure	Arm I: Dasatinib n=3 Participants Patients receive 100 mg orally twice a day.	Arm II: Dasatinib n=4 Participants Patients receive 70 mg orally twice a day.
Objective Response Rate (Complete Response and Partial Response)	0 percentage of patients	0 percentage of patients

SECONDARY outcome

Timeframe: Time from start of treatment to time of progression, assessed up to 12 weeks

Population: The second treatment arm of Dasatinib 70 mg orally twice a day was created as a result of an amendment to the protocol therefore the patient PFS data was combined for each arm.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Outcome measures

Outcome measures
Measure	Arm I: Dasatinib n=7 Participants Patients receive 100 mg orally twice a day.	Arm II: Dasatinib Patients receive 70 mg orally twice a day.
Progression-free Survival	4 weeks Interval 4.0 to 8.0	—

SECONDARY outcome

Timeframe: At baseline

Population: Funding was not available to do correlative studies

Performed per standard protocols by the Pathology Department.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At baseline

Population: Funding was not available to do correlative studies

Performed per standard protocols by the Pathology Department. Samples will be obtained pre-therapy. Determination of the COX-2 tumor status on this trial will develop the beginnings of a data base upon which future therapy may be designed.

Outcome measures

Outcome data not reported

Adverse Events

Dasatinib 100 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Dasatinib 70 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dasatinib 100 mg n=3 participants at risk Patients receive the initial dose of 100 mg orally twice a day.	Dasatinib 70 mg n=4 participants at risk Patients receive the initial dose of 70 mg orally twice a day. Dose was reduced to 70 mg orally based on toxicity.
Blood and lymphatic system disorders Hemorrhage/Bleeding	33.3% 1/3 • Number of events 1 • Patients will be evaluated for Adverse Events from week 1 up until 12 weeks. Toxicities were graded using the Common Toxicity Criteria Version 3.0 (CTC 3.0)	0.00% 0/4 • Patients will be evaluated for Adverse Events from week 1 up until 12 weeks. Toxicities were graded using the Common Toxicity Criteria Version 3.0 (CTC 3.0)
Metabolism and nutrition disorders Hyperglycemia	33.3% 1/3 • Number of events 1 • Patients will be evaluated for Adverse Events from week 1 up until 12 weeks. Toxicities were graded using the Common Toxicity Criteria Version 3.0 (CTC 3.0)	0.00% 0/4 • Patients will be evaluated for Adverse Events from week 1 up until 12 weeks. Toxicities were graded using the Common Toxicity Criteria Version 3.0 (CTC 3.0)
Vascular disorders Thrombosis/thrombus/embolism	33.3% 1/3 • Number of events 1 • Patients will be evaluated for Adverse Events from week 1 up until 12 weeks. Toxicities were graded using the Common Toxicity Criteria Version 3.0 (CTC 3.0)	0.00% 0/4 • Patients will be evaluated for Adverse Events from week 1 up until 12 weeks. Toxicities were graded using the Common Toxicity Criteria Version 3.0 (CTC 3.0)
Vascular disorders Vascular- other	33.3% 1/3 • Number of events 1 • Patients will be evaluated for Adverse Events from week 1 up until 12 weeks. Toxicities were graded using the Common Toxicity Criteria Version 3.0 (CTC 3.0)	0.00% 0/4 • Patients will be evaluated for Adverse Events from week 1 up until 12 weeks. Toxicities were graded using the Common Toxicity Criteria Version 3.0 (CTC 3.0)
Infections and infestations Pneumonia	0.00% 0/3 • Patients will be evaluated for Adverse Events from week 1 up until 12 weeks. Toxicities were graded using the Common Toxicity Criteria Version 3.0 (CTC 3.0)	25.0% 1/4 • Number of events 1 • Patients will be evaluated for Adverse Events from week 1 up until 12 weeks. Toxicities were graded using the Common Toxicity Criteria Version 3.0 (CTC 3.0)
Infections and infestations Urinary tract infection	0.00% 0/3 • Patients will be evaluated for Adverse Events from week 1 up until 12 weeks. Toxicities were graded using the Common Toxicity Criteria Version 3.0 (CTC 3.0)	25.0% 1/4 • Number of events 1 • Patients will be evaluated for Adverse Events from week 1 up until 12 weeks. Toxicities were graded using the Common Toxicity Criteria Version 3.0 (CTC 3.0)

Additional Information

Thomas Olencki, DO

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-2886

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60