Trial Outcomes & Findings for Vinflunine in Hormone Refractory Prostate Cancer (HRPC) (NCT NCT00545766)
NCT ID: NCT00545766
Last Updated: 2021-12-16
Results Overview
Defined as the percentage of patients with an objective decrease in PSA and/or experience an objective benefit from treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
18 months
Results posted on
2021-12-16
Participant Flow
Participant milestones
| Measure |
Vinflunine
Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
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|---|---|
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Overall Study
STARTED
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41
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Overall Study
COMPLETED
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36
|
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Overall Study
NOT COMPLETED
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5
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vinflunine in Hormone Refractory Prostate Cancer (HRPC)
Baseline characteristics by cohort
| Measure |
Vinflunine
n=41 Participants
Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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7 Participants
n=5 Participants
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Age, Categorical
>=65 years
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34 Participants
n=5 Participants
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Age, Continuous
|
72 years
STANDARD_DEVIATION 8.4 • n=5 Participants
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|
Sex: Female, Male
Female
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0 Participants
n=5 Participants
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Sex: Female, Male
Male
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41 Participants
n=5 Participants
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Region of Enrollment
United States
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41 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 18 monthsPopulation: Five patients did not receive two full cycles of vinflunine and were not included in the analysis
Defined as the percentage of patients with an objective decrease in PSA and/or experience an objective benefit from treatment.
Outcome measures
| Measure |
Vinflunine
n=36 Participants
Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
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|---|---|
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Protein-specific Antigen (PSA) Response Rate
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3 percentage of patients
Interval -2.57 to 8.57
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SECONDARY outcome
Timeframe: 18 monthsPopulation: 38 patients with serial PSA evaluations were included in the analysis. 3 patients only had baseline evaluations and were not included in analysis.
Time to PSA Progression is defined as the time from the first dose administration to the date when criteria for PSA progression (for Progressive Disease) are initially met.
Outcome measures
| Measure |
Vinflunine
n=38 Participants
Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
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|---|---|
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Time to PSA Progression
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12.2 weeks
Interval 2.7 to 57.1
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SECONDARY outcome
Timeframe: 18 monthsProgression free survival is defined as the time from the first day of treatment until the day tumor progression was documented. Response categories were assigned after completion of two weeks of vinflunine therapy using Response Evaluation Criteria in Solid Tumors (RECIST). Progressive disease is defined as an increase in \>=25% of of serum PSA above baseline value documented by at least two successive values separated by at least one week.
Outcome measures
| Measure |
Vinflunine
n=36 Participants
Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
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|---|---|
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Progression Free Survival
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2.1 months
Interval 1.4 to 2.9
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SECONDARY outcome
Timeframe: 18 monthsOS is defined as the time from the first treatment until date of death due to any cause. In the absence of confirmation of death or lack of data beyond follow-up period, the survival time was censored to last date the participant was known to be alive. Number of participants experiencing overall survival is reported here.
Outcome measures
| Measure |
Vinflunine
n=41 Participants
Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
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|---|---|
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Number of Participants Experiencing Overall Survival (OS)
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15 Participants
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Adverse Events
Vinflunine
Serious events: 11 serious events
Other events: 33 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
Vinflunine
n=41 participants at risk
Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
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|---|---|
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General disorders
Pain - abdomen
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4.9%
2/41 • Number of events 2 • 18 months
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Blood and lymphatic system disorders
Hemoglobin
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2.4%
1/41 • Number of events 1 • 18 months
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Infections and infestations
Infection - Pneumonia
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2.4%
1/41 • Number of events 1 • 18 months
|
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Cardiac disorders
Cardiac arrhythmia
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2.4%
1/41 • Number of events 1 • 18 months
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Cardiac disorders
Cardiac ischemia
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2.4%
1/41 • Number of events 1 • 18 months
|
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Gastrointestinal disorders
Dehydration
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7.3%
3/41 • Number of events 4 • 18 months
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression
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7.3%
3/41 • Number of events 3 • 18 months
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Blood and lymphatic system disorders
Febrile neutropenia
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2.4%
1/41 • Number of events 1 • 18 months
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Renal and urinary disorders
Renal failure
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2.4%
1/41 • Number of events 1 • 18 months
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General disorders
Pain - back
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2.4%
1/41 • Number of events 1 • 18 months
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Other adverse events
| Measure |
Vinflunine
n=41 participants at risk
Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
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|---|---|
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Gastrointestinal disorders
Abdominal pain
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22.0%
9/41 • Number of events 10 • 18 months
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Skin and subcutaneous tissue disorders
Alopecia
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19.5%
8/41 • Number of events 11 • 18 months
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Blood and lymphatic system disorders
ANC
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73.2%
30/41 • Number of events 50 • 18 months
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Gastrointestinal disorders
Anorexia
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34.1%
14/41 • Number of events 23 • 18 months
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Musculoskeletal and connective tissue disorders
Arthralgia
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17.1%
7/41 • Number of events 9 • 18 months
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Musculoskeletal and connective tissue disorders
Bone pain
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26.8%
11/41 • Number of events 20 • 18 months
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Gastrointestinal disorders
Constipation
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53.7%
22/41 • Number of events 36 • 18 months
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Gastrointestinal disorders
Dehydration
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7.3%
3/41 • Number of events 6 • 18 months
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Nervous system disorders
Depression
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4.9%
2/41 • Number of events 4 • 18 months
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Gastrointestinal disorders
Diarrhea
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22.0%
9/41 • Number of events 9 • 18 months
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Gastrointestinal disorders
Dyspepsia
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14.6%
6/41 • Number of events 6 • 18 months
|
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Respiratory, thoracic and mediastinal disorders
Dyspnea
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19.5%
8/41 • Number of events 14 • 18 months
|
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Vascular disorders
Edema
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14.6%
6/41 • Number of events 12 • 18 months
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General disorders
Fatigue
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80.5%
33/41 • Number of events 72 • 18 months
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Infections and infestations
Febrile Neutropenia
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9.8%
4/41 • Number of events 5 • 18 months
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Nervous system disorders
Headache
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12.2%
5/41 • Number of events 9 • 18 months
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Blood and lymphatic system disorders
HGB
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75.6%
31/41 • Number of events 76 • 18 months
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Endocrine disorders
Hot flashes
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9.8%
4/41 • Number of events 5 • 18 months
|
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Infections and infestations
Infection without Neutropenia
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9.8%
4/41 • Number of events 5 • 18 months
|
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Skin and subcutaneous tissue disorders
Injection Site Reaction
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17.1%
7/41 • Number of events 10 • 18 months
|
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Musculoskeletal and connective tissue disorders
Myalgia
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19.5%
8/41 • Number of events 11 • 18 months
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Gastrointestinal disorders
Nausea
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41.5%
17/41 • Number of events 27 • 18 months
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General disorders
Pain
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4.9%
2/41 • Number of events 3 • 18 months
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Musculoskeletal and connective tissue disorders
Pain (back)
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7.3%
3/41 • Number of events 3 • 18 months
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Blood and lymphatic system disorders
PLT
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31.7%
13/41 • Number of events 21 • 18 months
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Skin and subcutaneous tissue disorders
Rash
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4.9%
2/41 • Number of events 2 • 18 months
|
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Nervous system disorders
Sensory Neuropathy
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17.1%
7/41 • Number of events 15 • 18 months
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Gastrointestinal disorders
Stomatitis
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4.9%
2/41 • Number of events 2 • 18 months
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Renal and urinary disorders
Urinary frequency
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4.9%
2/41 • Number of events 2 • 18 months
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Gastrointestinal disorders
Vomiting
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22.0%
9/41 • Number of events 11 • 18 months
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Blood and lymphatic system disorders
WBC
|
78.0%
32/41 • Number of events 59 • 18 months
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General disorders
Weakness
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22.0%
9/41 • Number of events 13 • 18 months
|
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General disorders
Weight Loss
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17.1%
7/41 • Number of events 9 • 18 months
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
- Publication restrictions are in place
Restriction type: OTHER