Trial Outcomes & Findings for Trial of Dasatinib (Sprycel®) in Subjects With Hormone-refractory Prostate Cancer (NCT NCT00570700)

Last Updated: 2019-02-26

Results Overview

A "positive effect" will be defined as a complete response, partial response, or stable disease. "Lack of positive effect" will be defined as progressive disease. Subjects with a mixed response should be continued on therapy until they either fulfill the criteria for positive effect or lack of positive effect, with evaluation every 56 days. The disease control (DC) rate was evaluated as a composite endpoint of the treatment effect on four parameters: 1) Prostate-specific antigen (PSA), 2) measurable disease (if present) by RECIST criteria, 3) bone scan, and 4) quality-of-life as measured by the FACT-P questionnaire.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

38 participants

Primary outcome timeframe

From day 56 (8 weeks) and every 8 weeks thereafter until the date of first documented progression or date of death from any cause, whichever came first, assessed until death, the patient withdraws consent, or the study ends, up to 2 years

Results posted on

2019-02-26

Participant Flow

Participant milestones

Participant milestones
Measure	Dasatinib Patients receive oral dasatinib once daily in the absence of disease progression or unacceptable toxicity. Dasatinib: 150mg (3 pills) orally daily for as long as the drug benefits
Overall Study STARTED	38
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of Dasatinib (Sprycel®) in Subjects With Hormone-refractory Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dasatinib n=38 Participants Patients receive oral dasatinib once daily in the absence of disease progression or unacceptable toxicity. Dasatinib: 150mg (3 pills) orally daily for as long as the drug benefits
Age, Continuous	68 years n=5 Participants
Sex/Gender, Customized Male	38 participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	5 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Region of Enrollment United States	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: From day 56 (8 weeks) and every 8 weeks thereafter until the date of first documented progression or date of death from any cause, whichever came first, assessed until death, the patient withdraws consent, or the study ends, up to 2 years

Population: 27 subjects were evaluable for response.

Outcome measures

Outcome measures
Measure	Dasatinib n=27 Participants Patients receive oral dasatinib once daily in the absence of disease progression or unacceptable toxicity. Dasatinib: 150mg (3 pills) orally daily for as long as the drug benefits
Number of Subjects With Disease Control (DC) (Based on PSA, Bone Scan, FACT-P, RECIST)	5 Participants

SECONDARY outcome

Timeframe: From initial date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

Population: Data not collected due to relatively poor drug tolerance and relatively rapid PSA increases in most patients as it was not feasible to continue patients on treatment.

Time to PSA progression, defined as the interval from the first day of dasatinib treatment until either (1) there has been a 50% increase in PSA above the treatment nadir, with a minimum of 5ng/mL, or (2) a 25% increase in PSA level above pretreatment levels, with a minimum of 5ng/mL. All PSA-based assessments require a confirmatory level no more than 1 month later.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From initial date of treatment through study completion, up to 2 years

Due to relatively poor drug tolerance and relatively rapid PSA increases in most patients it was not feasible to continue patients on treatment until there was radiographic evidence of disease progression.

Outcome measures

Outcome measures
Measure	Dasatinib n=27 Participants Patients receive oral dasatinib once daily in the absence of disease progression or unacceptable toxicity. Dasatinib: 150mg (3 pills) orally daily for as long as the drug benefits
Number of Subjects With Dasatinib Toxicity Using Common Terminology Criteria (CTC) (v. 3.0)	12 Participants

Adverse Events

Dasatinib

Serious events: 17 serious events

Other events: 11 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Dasatinib n=38 participants at risk Patients receive oral dasatinib once daily in the absence of disease progression or unacceptable toxicity. Dasatinib: 150mg (3 pills) orally daily for as long as the drug benefits
General disorders Fatigue/asthenia	13.2% 5/38 • 4 years
Gastrointestinal disorders Diarrhea	5.3% 2/38 • 4 years
Respiratory, thoracic and mediastinal disorders Dyspnea	5.3% 2/38 • 4 years
Gastrointestinal disorders GI bleed	5.3% 2/38 • 4 years
Blood and lymphatic system disorders Hyponatremia	5.3% 2/38 • 4 years
Blood and lymphatic system disorders Elevated lipase	2.6% 1/38 • 4 years
Cardiac disorders Pleural / pericardial effusion	2.6% 1/38 • 4 years
Blood and lymphatic system disorders Anemia	2.6% 1/38 • 4 years
Blood and lymphatic system disorders Venous thrombosis	2.6% 1/38 • 4 years

Other adverse events

Other adverse events
Measure	Dasatinib n=38 participants at risk Patients receive oral dasatinib once daily in the absence of disease progression or unacceptable toxicity. Dasatinib: 150mg (3 pills) orally daily for as long as the drug benefits
Psychiatric disorders Anorexia	5.3% 2/38 • 4 years
Psychiatric disorders Decreased Appetite	7.9% 3/38 • 4 years
Blood and lymphatic system disorders Elevated Alkaline Phosphatase Levels	7.9% 3/38 • 4 years
Blood and lymphatic system disorders Elevated Amylase	10.5% 4/38 • 4 years
Blood and lymphatic system disorders Elevated Aspartate Aminotransferase Levels	7.9% 3/38 • 4 years
Blood and lymphatic system disorders Elevated lipase levels	5.3% 2/38 • 4 years
Skin and subcutaneous tissue disorders Erythema	7.9% 3/38 • 4 years
General disorders Fatigue	15.8% 6/38 • 4 years
Gastrointestinal disorders Diarrhea	7.9% 3/38 • 4 years
General disorders Nausea	5.3% 2/38 • 4 years
Respiratory, thoracic and mediastinal disorders Cough	5.3% 2/38 • 4 years
Respiratory, thoracic and mediastinal disorders Pleural Effusion	7.9% 3/38 • 4 years
General disorders Headache	5.3% 2/38 • 4 years

Additional Information

UC Irvine Health / Chao Family Comprehensive Cancer Center

Phone: 1-877-UC-STUDY

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place