Trial Outcomes & Findings for Fenretinide in Treating Patients With Biochemically Recurrent Hormone-Naïve Prostate Cancer (NCT NCT00080899)
NCT ID: NCT00080899
Last Updated: 2015-03-06
Results Overview
PSA normalization (PSA-N) was recorded as the best PSA response when a PSA level was undetectable (\< 0.1 ng/ml), and was then subsequently confirmed by a second measurement ≥ 4 weeks later. PSA partial response (PSA-PR) was recorded if the PSA decreased by ≥ 50% from pre-treatment or baseline values and was confirmed by a second measurement made ≥ 4 weeks later. Response = PSA-N + PSA-PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Baseline to 5 years
Results posted on
2015-03-06
Participant Flow
Participant milestones
| Measure |
Arm 1
Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide \[4-HPR\]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Arm 1
Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide \[4-HPR\]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
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|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Fenretinide in Treating Patients With Biochemically Recurrent Hormone-Naïve Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm 1
n=23 Participants
Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide \[4-HPR\]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
|
|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 5 yearsPSA normalization (PSA-N) was recorded as the best PSA response when a PSA level was undetectable (\< 0.1 ng/ml), and was then subsequently confirmed by a second measurement ≥ 4 weeks later. PSA partial response (PSA-PR) was recorded if the PSA decreased by ≥ 50% from pre-treatment or baseline values and was confirmed by a second measurement made ≥ 4 weeks later. Response = PSA-N + PSA-PR.
Outcome measures
| Measure |
Arm 1
n=22 Participants
Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide \[4-HPR\]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
|
|---|---|
|
PSA Response
|
0 participants
|
SECONDARY outcome
Timeframe: From the start of treatment until the date of the first documentation of PSA progression, assessed up to 5 yearsWas summarized using the product-limit (Kaplan-Meier) method. In patients whose PSA levels initially decreased, PSA progression was defined as a 25% increase over the nadir (postenrollment PSA value up to that point), and an increase in the absolute value in the PSA value of 5 ng/mL, relative to the lowest postenrollment PSA value up to that point, including the baseline PSA level - and which was confirmed by second value 3-4 weeks later. A best response of PSA-PD was recorded for those patients who did not achieve a confirmed PSA-N or PSA-PR and who experienced PSA progression within 3 months of start of treatment.
Outcome measures
| Measure |
Arm 1
n=23 Participants
Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide \[4-HPR\]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
|
|---|---|
|
Time to PSA Progression
|
4.6 months
Interval 3.2 to 8.2
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1
n=23 participants at risk
Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide \[4-HPR\]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
17.4%
4/23 • Number of events 23 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
4.3%
1/23 • Number of events 2 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Dry eye syndrome
|
13.0%
3/23 • Number of events 15 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Eye disorder
|
8.7%
2/23 • Number of events 2 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Flashing vision
|
34.8%
8/23 • Number of events 51 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Night blindness
|
43.5%
10/23 • Number of events 45 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Photophobia
|
21.7%
5/23 • Number of events 13 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Proptosis
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Vision blurred
|
13.0%
3/23 • Number of events 5 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.7%
2/23 • Number of events 6 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Cheilitis
|
4.3%
1/23 • Number of events 4 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
17.4%
4/23 • Number of events 9 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
34.8%
8/23 • Number of events 30 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
8.7%
2/23 • Number of events 2 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Flatulence
|
26.1%
6/23 • Number of events 18 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
21.7%
5/23 • Number of events 11 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chills
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Disease progression
|
8.7%
2/23 • Number of events 2 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Edema limbs
|
8.7%
2/23 • Number of events 4 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue
|
13.0%
3/23 • Number of events 22 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Flu-like symptoms
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Irritability
|
4.3%
1/23 • Number of events 2 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Skin infection
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alanine aminotransferase increased
|
8.7%
2/23 • Number of events 4 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alkaline phosphatase increased
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Amylase increased
|
13.0%
3/23 • Number of events 11 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
13.0%
3/23 • Number of events 11 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Bilirubin increased
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Creatinine increased
|
13.0%
3/23 • Number of events 7 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Hyperbilirubinemia
|
17.4%
4/23 • Number of events 17 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Hypercholesterolemia
|
8.7%
2/23 • Number of events 5 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lipase increased
|
13.0%
3/23 • Number of events 5 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lymphopenia
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelet count decreased
|
8.7%
2/23 • Number of events 17 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
8.7%
2/23 • Number of events 8 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.0%
3/23 • Number of events 11 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
4.3%
1/23 • Number of events 3 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
39.1%
9/23 • Number of events 24 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.7%
2/23 • Number of events 6 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
13.0%
3/23 • Number of events 11 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
13.0%
3/23 • Number of events 3 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
17.4%
4/23 • Number of events 23 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.4%
4/23 • Number of events 16 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
21.7%
5/23 • Number of events 18 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.4%
4/23 • Number of events 17 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Dizziness
|
17.4%
4/23 • Number of events 9 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Headache
|
13.0%
3/23 • Number of events 5 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Trigeminal nerve disorder
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Depression
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Breast pain
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
52.2%
12/23 • Number of events 46 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
8.7%
2/23 • Number of events 14 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
17.4%
4/23 • Number of events 4 • Adverse events were collected over a period of 2 years and 9 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60