Trial Outcomes & Findings for CP-675,206 in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer (NCT NCT00702923)
NCT ID: NCT00702923
Last Updated: 2019-11-21
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Up to 12 months after treatment with study agent
Results posted on
2019-11-21
Participant Flow
Participant milestones
| Measure |
CP-675,206 in Combination With Short Term Androgen Deprivation
Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
CP-675,206 in Combination With Short Term Androgen Deprivation
Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
CP-675,206 in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer
Baseline characteristics by cohort
| Measure |
CP-675,206 in Combination With Short Term Androgen Deprivation
n=12 Participants
Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
64.7 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 months after treatment with study agentOutcome measures
| Measure |
CP-675,206 3mg/kg
n=6 Participants
Dose level -1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 3mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
|
CP-675,206 6mg/kg
n=5 Participants
Dose level 1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 6mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
|
|---|---|---|
|
The Number of Participants Who Developed Cancer Antigen-specific Immune Responses
one or more prostate-associated antigens
|
6 participants
|
5 participants
|
|
The Number of Participants Who Developed Cancer Antigen-specific Immune Responses
antibodies specific for PSA
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Up to 18 months after last dose of study agentOutcome measures
| Measure |
CP-675,206 3mg/kg
n=6 Participants
Dose level -1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 3mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
|
CP-675,206 6mg/kg
n=5 Participants
Dose level 1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 6mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
|
|---|---|---|
|
The Number of Participants With an Increase in PSA Doubling Time
immediate post-treatment period (6-12 months)
|
0 participants
|
0 participants
|
|
The Number of Participants With an Increase in PSA Doubling Time
12-18 months after treatment
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: one yearPSA recurrence is defined as a minimum PSA value of greater or equal to 1.0ng/ml occurring within one year after the last treatment with CP-675,206, with a confirmatory PSA blood teat performed at least 2 weeks later.
Outcome measures
| Measure |
CP-675,206 3mg/kg
n=6 Participants
Dose level -1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 3mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
|
CP-675,206 6mg/kg
n=5 Participants
Dose level 1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 6mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
|
|---|---|---|
|
Number of Participants With PSA Recurrence.
|
6 participants
|
5 participants
|
Adverse Events
CP-675,206 in Combination With Short Term Androgen Deprivation
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CP-675,206 in Combination With Short Term Androgen Deprivation
n=12 participants at risk
Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
|
|---|---|
|
Immune system disorders
Autoimmune Reaction
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
8.3%
1/12 • Number of events 1
|
Other adverse events
| Measure |
CP-675,206 in Combination With Short Term Androgen Deprivation
n=12 participants at risk
Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
25.0%
3/12 • Number of events 3
|
|
Immune system disorders
Allergic Rhinitis
|
16.7%
2/12 • Number of events 2
|
|
Immune system disorders
Autoimmune Reaction
|
8.3%
1/12 • Number of events 1
|
|
Cardiac disorders
Hypertension
|
8.3%
1/12 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Fatigue
|
58.3%
7/12 • Number of events 11
|
|
General disorders
Fever
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Rigors/chills
|
16.7%
2/12 • Number of events 2
|
|
General disorders
Weight Loss
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other
|
25.0%
3/12 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
33.3%
4/12 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
25.0%
3/12 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Acne/acneiform
|
33.3%
4/12 • Number of events 6
|
|
Endocrine disorders
Hot flashes/flushes
|
33.3%
4/12 • Number of events 6
|
|
Gastrointestinal disorders
Anorexia
|
16.7%
2/12 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
3/12 • Number of events 9
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
16.7%
2/12 • Number of events 3
|
|
Gastrointestinal disorders
Gastrointestinal--Other
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Incontinence, anal
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis/sttomatitis (clinical exam)--Oral Cavity
|
16.7%
2/12 • Number of events 3
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) --Anus
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis/stomatits (functional/symptomatic)--Oral Cavity
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
25.0%
3/12 • Number of events 5
|
|
Renal and urinary disorders
Hemorrhage, GU--Bladder
|
8.3%
1/12 • Number of events 1
|
|
Renal and urinary disorders
Hemorrhage, Gu--Urinary NOS
|
16.7%
2/12 • Number of events 2
|
|
Renal and urinary disorders
Hemorrhage/bleeding--Other
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils--Sinus
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils--Skin
|
8.3%
1/12 • Number of events 1
|
|
Blood and lymphatic system disorders
Edema: limb
|
16.7%
2/12 • Number of events 2
|
|
Investigations
Amylase
|
8.3%
1/12 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area--Extremity-lower
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Mood alteration--Agitation
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Mood alteration--Anxiety
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Mood alteration--Depression
|
16.7%
2/12 • Number of events 4
|
|
Nervous system disorders
Neurology--Other
|
8.3%
1/12 • Number of events 1
|
|
Eye disorders
Dry eye syndrome
|
8.3%
1/12 • Number of events 1
|
|
Eye disorders
Ocular/Visual--Other
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
2/12 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthiria
|
8.3%
1/12 • Number of events 1
|
|
Renal and urinary disorders
Renal/Genitourinary--Other
|
8.3%
1/12 • Number of events 2
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
16.7%
2/12 • Number of events 2
|
|
Renal and urinary disorders
Urinary retention
|
16.7%
2/12 • Number of events 3
|
|
Reproductive system and breast disorders
Gynecomastia
|
33.3%
4/12 • Number of events 4
|
|
Gastrointestinal disorders
Pain--Abdomen NOS
|
33.3%
4/12 • Number of events 6
|
|
Reproductive system and breast disorders
Pain - Breast
|
25.0%
3/12 • Number of events 3
|
|
Nervous system disorders
Pain - Head/headache
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
8.3%
1/12 • Number of events 1
|
|
General disorders
flu-like syndrome
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain - neck
|
8.3%
1/12 • Number of events 1
|
Additional Information
Douglas McNeel, M.D., Ph.D.
University of Wisconsin Carbone Cancer Center
Phone: (608) 263-4198
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place