Trial Outcomes & Findings for Quinacrine Treatment in Patients With Androgen-Independent Prostate Cancer (NCT NCT00417274)
NCT ID: NCT00417274
Last Updated: 2013-04-11
Results Overview
Patients who achieved a complete response (CR) or a partial response (PR) to therapy were allowed to continue to receive treatment until disease progression or unacceptable toxicity occurred, until the patient discontinued treatment for another reason, or for a total of 6 months. Patients who continued to show a CR or PR or who maintained stable disease (SD) after 6 months of therapy were to be allowed to continue therapy at the investigator's discretion.
COMPLETED
PHASE2
31 participants
End of treatment
2013-04-11
Participant Flow
Participant milestones
| Measure |
Quinacrine Treatment
100 mg once a day
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Quinacrine Treatment in Patients With Androgen-Independent Prostate Cancer
Baseline characteristics by cohort
| Measure |
Quinacrine Treatment
n=31 Participants
Uncontrolled treatment arm
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
|
Age Continuous
|
68 years
STANDARD_DEVIATION 9.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of treatmentPopulation: Based on clinical judgment
Patients who achieved a complete response (CR) or a partial response (PR) to therapy were allowed to continue to receive treatment until disease progression or unacceptable toxicity occurred, until the patient discontinued treatment for another reason, or for a total of 6 months. Patients who continued to show a CR or PR or who maintained stable disease (SD) after 6 months of therapy were to be allowed to continue therapy at the investigator's discretion.
Outcome measures
| Measure |
Quinacrine Treatment
n=31 Participants
100 mg once a day
|
|---|---|
|
Efficacy of Quinacrine, Based on Prostate Specific Antigen (PSA) Response in Patients With Androgen-independent Metastatic Prostate Cancer
|
1 Participants
|
Adverse Events
Quinacrine Treatment
Serious adverse events
| Measure |
Quinacrine Treatment
n=31 participants at risk
Uncontrolled treatment arm
|
|---|---|
|
Vascular disorders
Thrombosis
|
3.2%
1/31 • Number of events 1 • 18 months
|
|
Infections and infestations
sepsis
|
3.2%
1/31 • Number of events 1 • 18 months
|
|
General disorders
Back pain
|
3.2%
1/31 • Number of events 1 • 18 months
|
Other adverse events
| Measure |
Quinacrine Treatment
n=31 participants at risk
Uncontrolled treatment arm
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
16.1%
5/31 • Number of events 5 • 18 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.7%
3/31 • Number of events 3 • 18 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
22.6%
7/31 • Number of events 7 • 18 months
|
|
Cardiac disorders
Electrocardiogram QTc interval prolonged
|
6.5%
2/31 • Number of events 2 • 18 months
|
|
General disorders
Fatigue
|
35.5%
11/31 • Number of events 11 • 18 months
|
|
General disorders
Fever
|
6.5%
2/31 • Number of events 2 • 18 months
|
|
General disorders
Insomnia
|
6.5%
2/31 • Number of events 2 • 18 months
|
|
General disorders
Weight loss
|
22.6%
7/31 • Number of events 7 • 18 months
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
29.0%
9/31 • Number of events 9 • 18 months
|
|
Gastrointestinal disorders
anorexia
|
29.0%
9/31 • Number of events 9 • 18 months
|
|
Gastrointestinal disorders
constipation
|
16.1%
5/31 • Number of events 5 • 18 months
|
|
Gastrointestinal disorders
diarrhea
|
6.5%
2/31 • Number of events 2 • 18 months
|
|
Gastrointestinal disorders
mucositis
|
6.5%
2/31 • Number of events 2 • 18 months
|
|
Gastrointestinal disorders
taste alteration
|
29.0%
9/31 • Number of events 9 • 18 months
|
|
Gastrointestinal disorders
Vomiting
|
9.7%
3/31 • Number of events 3 • 18 months
|
|
Gastrointestinal disorders
nausea
|
29.0%
9/31 • Number of events 9 • 18 months
|
|
Blood and lymphatic system disorders
edema limbs
|
19.4%
6/31 • Number of events 6 • 18 months
|
|
Investigations
Alkaline phosphatse increased
|
22.6%
7/31 • Number of events 7 • 18 months
|
|
Investigations
creatinine increased
|
12.9%
4/31 • Number of events 4 • 18 months
|
|
Investigations
Hyperglycemia
|
19.4%
6/31 • Number of events 6 • 18 months
|
|
Investigations
hypoalbuminemia
|
6.5%
2/31 • Number of events 2 • 18 months
|
|
Musculoskeletal and connective tissue disorders
joint disorder
|
9.7%
3/31 • Number of events 3 • 18 months
|
|
Musculoskeletal and connective tissue disorders
muscle weakness
|
6.5%
2/31 • Number of events 2 • 18 months
|
|
Nervous system disorders
dizziness
|
16.1%
5/31 • Number of events 5 • 18 months
|
|
Musculoskeletal and connective tissue disorders
back pain
|
16.1%
5/31 • Number of events 5 • 18 months
|
|
Musculoskeletal and connective tissue disorders
chest pain
|
9.7%
3/31 • Number of events 3 • 18 months
|
|
Nervous system disorders
headache
|
16.1%
5/31 • Number of events 5 • 18 months
|
|
General disorders
pain
|
38.7%
12/31 • Number of events 12 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
9.7%
3/31 • Number of events 3 • 18 months
|
|
Renal and urinary disorders
urogenital disorder
|
12.9%
4/31 • Number of events 4 • 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60