Trial Outcomes & Findings for Saracatinib in Treating Patients With Prostate Cancer (NCT NCT01267266)

Last Updated: 2015-04-01

Results Overview

Time to progression will be assessed using the Kaplan-Meier method and compared between groups via Wilcoxon rank-sum test.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

31 participants

Primary outcome timeframe

Up to 6 months.

Results posted on

2015-04-01

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Saracatinib) Patients receive 175 mg oral saracatinib once daily on days 1-28.	Arm II (Placebo) Patients receive oral placebo once daily on days 1-28.
Enrollment Phase STARTED	33	0
Enrollment Phase COMPLETED	31	0
Enrollment Phase NOT COMPLETED	2	0
Lead-in Phase STARTED	31	0
Lead-in Phase COMPLETED	8	0
Lead-in Phase NOT COMPLETED	23	0
Randomized Phase STARTED	3	5
Randomized Phase COMPLETED	3	5
Randomized Phase NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Saracatinib) Patients receive 175 mg oral saracatinib once daily on days 1-28.	Arm II (Placebo) Patients receive oral placebo once daily on days 1-28.
Enrollment Phase Withdrawal by Subject	2	0
Lead-in Phase Lack of Efficacy	20	0
Lead-in Phase Adverse Event	2	0
Lead-in Phase Withdrawal by Subject	1	0

Baseline Characteristics

Saracatinib in Treating Patients With Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Saracatinib) n=31 Participants Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Age, Continuous	71 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 months.

Population: Two patients in the placebo arm censored at 12 and 17 weeks, respectively.

Time to progression will be assessed using the Kaplan-Meier method and compared between groups via Wilcoxon rank-sum test.

Outcome measures

Outcome measures
Measure	Arm I (Saracatinib) n=3 Participants Patients receive oral saracatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. saracatinib: Given orally	Arm II (Placebo) n=5 Participants Patients receive oral placebo once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Upon progression, patients may crossover to arm I. hydrocortisone/placebo: Given orally
Duration of Stable Disease. (Time to Disease Progression by CT and/or Bone Scan or Clinical Progression.)	18 weeks Interval 17.0 to 19.0	12 weeks Interval 9.0 to 17.0

SECONDARY outcome

Timeframe: Up to 6 months.

Percentage of patients with grade 4 toxicity.

Outcome measures

Outcome measures
Measure	Arm I (Saracatinib) n=3 Participants Patients receive oral saracatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. saracatinib: Given orally	Arm II (Placebo) n=5 Participants Patients receive oral placebo once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Upon progression, patients may crossover to arm I. hydrocortisone/placebo: Given orally
Toxicity and Incidence of Adverse Events	0.0 percentage of participants Interval 0.0 to 70.8	0.0 percentage of participants Interval 0.0 to 52.2

SECONDARY outcome

Timeframe: Up to 6 months.

Percentage of patients who discontinued therapy due to toxicity.

Outcome measures

Outcome measures
Measure	Arm I (Saracatinib) n=3 Participants Patients receive oral saracatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. saracatinib: Given orally	Arm II (Placebo) n=5 Participants Patients receive oral placebo once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Upon progression, patients may crossover to arm I. hydrocortisone/placebo: Given orally
Toxicity and Incidence of Adverse Events.	0.0 percentage of participants Interval 0.0 to 70.8	20.0 percentage of participants Interval 0.5 to 71.6

SECONDARY outcome

Timeframe: Up to 2 years

Study terminated after randomization of only 8 subjects. Correlative data not analyzed.

Outcome measures

Outcome data not reported

Adverse Events

Saracatinib, Lead-in Phase

Serious events: 1 serious events

Other events: 29 other events

Deaths: 0 deaths

Saracatinib, Randomized Phase

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo, Randomized Phase

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Saracatinib, Lead-in Phase n=31 participants at risk Patients receive 175 mg oral saracatinib once daily on days 1-28.	Saracatinib, Randomized Phase n=3 participants at risk Patients receive 175 mg oral saracatinib once daily on days 1-28.	Placebo, Randomized Phase n=5 participants at risk Patients receive placebo once daily on days 1-28.
Metabolism and nutrition disorders Anemia	3.2% 1/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Musculoskeletal and connective tissue disorders Muscle weakness	0.00% 0/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	20.0% 1/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).

Other adverse events

Additional Information

Walter M. Stadler

University of Chicago

Phone: 773-702-4150

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Saracatinib, Lead-in Phase n=31 participants at risk Patients receive 175 mg oral saracatinib once daily on days 1-28.	Saracatinib, Randomized Phase n=3 participants at risk Patients receive 175 mg oral saracatinib once daily on days 1-28.	Placebo, Randomized Phase n=5 participants at risk Patients receive placebo once daily on days 1-28.
General disorders Fatigue	38.7% 12/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	66.7% 2/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	20.0% 1/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Metabolism and nutrition disorders Dehydration	12.9% 4/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Blood and lymphatic system disorders Thrombocytopenia	12.9% 4/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Metabolism and nutrition disorders Anorexia	41.9% 13/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	33.3% 1/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	20.0% 1/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Gastrointestinal disorders Nausea	29.0% 9/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	33.3% 1/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	20.0% 1/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Investigations Aspartate aminotransferase increased	22.6% 7/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Gastrointestinal disorders Vomiting	29.0% 9/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	33.3% 1/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	20.0% 1/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Gastrointestinal disorders Diarrhea	16.1% 5/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	20.0% 1/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Blood and lymphatic system disorders Anemia	25.8% 8/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Gastrointestinal disorders Constipation	25.8% 8/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	20.0% 1/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Renal and urinary disorders Creatinine increased	12.9% 4/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
General disorders Edema	12.9% 4/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
General disorders Fever	16.1% 5/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Renal and urinary disorders Hematuria	12.9% 4/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Blood and lymphatic system disorders Leukopenia	6.5% 2/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Musculoskeletal and connective tissue disorders Myalgia	6.5% 2/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Investigations Alanine aminotransferase increased	6.5% 2/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Investigations Alkaline phosphatase increased	6.5% 2/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Musculoskeletal and connective tissue disorders Arthralgia	6.5% 2/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Musculoskeletal and connective tissue disorders Back pain	6.5% 2/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Musculoskeletal and connective tissue disorders Bone pain	6.5% 2/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Psychiatric disorders Confusion	6.5% 2/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Nervous system disorders Dysgeusia	3.2% 1/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	33.3% 1/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Metabolism and nutrition disorders Hypocalcemia	9.7% 3/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Metabolism and nutrition disorders Hypokalemia	6.5% 2/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	20.0% 1/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Metabolism and nutrition disorders Hyponatremia	3.2% 1/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	20.0% 1/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Vascular disorders Hypotension	6.5% 2/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Nervous system disorders Neuropathy-sensory	9.7% 3/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Gastrointestinal disorders Oral pain	3.2% 1/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	33.3% 1/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
General disorders Pain	22.6% 7/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	33.3% 1/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	20.0% 1/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Respiratory, thoracic and mediastinal disorders Rhinorrhea	6.5% 2/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Renal and urinary disorders Urinary retention	3.2% 1/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	33.3% 1/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	20.0% 1/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Psychiatric disorders Anxiety	3.2% 1/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	20.0% 1/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	3.2% 1/31 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	0.00% 0/3 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).	20.0% 1/5 • Up to 6 months (lead-in phase); up to 2 months (randomized phase).