Trial Outcomes & Findings for A Study of Aplidin ( Plitidepsin) in Subjects With Advanced Prostate Cancer (NCT NCT00780975)
NCT ID: NCT00780975
Last Updated: 2020-11-24
Results Overview
TERMINATED
PHASE2
8 participants
All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first
2020-11-24
Participant Flow
Participant milestones
| Measure |
Aplidin®
Aplidin (Plitidepsin)
Aplidin (plitidepsin): Aplidin® administered at a starting dose of 5 mg/m2, as a 3-hours intravenous infusion, every 2 weeks.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Aplidin®
Aplidin (Plitidepsin)
Aplidin (plitidepsin): Aplidin® administered at a starting dose of 5 mg/m2, as a 3-hours intravenous infusion, every 2 weeks.
|
|---|---|
|
Overall Study
Progressive disease
|
3
|
|
Overall Study
Toxicity
|
5
|
Baseline Characteristics
A Study of Aplidin ( Plitidepsin) in Subjects With Advanced Prostate Cancer
Baseline characteristics by cohort
| Measure |
Aplidin®
n=8 Participants
Aplidin (Plitidepsin)
Aplidin (plitidepsin): Aplidin® administered at a starting dose of 5 mg/m2, as a 3-hours intravenous infusion, every 2 weeks.
|
|---|---|
|
Age, Continuous
|
60.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured firstOutcome measures
| Measure |
Aplidin®
n=8 Participants
Aplidin (Plitidepsin)
Aplidin (plitidepsin): Aplidin® administered at a starting dose of 5 mg/m2, as a 3-hours intravenous infusion, every 2 weeks.
|
|---|---|
|
The Percentage of Patients With a ≥ 50% Prostate-specific Antigen (PSA) Decline Post-therapy
PSA Progression
|
1 Participants
|
|
The Percentage of Patients With a ≥ 50% Prostate-specific Antigen (PSA) Decline Post-therapy
PSA Stabilization
|
4 Participants
|
|
The Percentage of Patients With a ≥ 50% Prostate-specific Antigen (PSA) Decline Post-therapy
PSA Progression NC
|
2 Participants
|
|
The Percentage of Patients With a ≥ 50% Prostate-specific Antigen (PSA) Decline Post-therapy
PSA Response NC
|
1 Participants
|
SECONDARY outcome
Timeframe: All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured firstPatients with an objective tumor response (complete response \[CR\] or partial response \[PR\]) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST), See Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, et al. New Guidelines to Evaluate the Response to Treatment in Solid Tumors. J Natl Cancer Inst 2000; 92:205-16.
Outcome measures
| Measure |
Aplidin®
n=8 Participants
Aplidin (Plitidepsin)
Aplidin (plitidepsin): Aplidin® administered at a starting dose of 5 mg/m2, as a 3-hours intravenous infusion, every 2 weeks.
|
|---|---|
|
Objective Tumor Response According to RECIST
stable disease
|
4 Participants
|
|
Objective Tumor Response According to RECIST
no response
|
3 Participants
|
|
Objective Tumor Response According to RECIST
non evaluable
|
1 Participants
|
SECONDARY outcome
Timeframe: All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured firstTo assess the antitumor activity of plitidepsin given intravenously over 3-hours every two weeks in patients with castrate metastatic adenocarcinoma of the prostate that have relapsed or progressed after 2 previous lines of systemic therapy, considering biological agents or chemotherapy as systemic therapy and taking into account that patients must have received prior docetaxel-based chemotherapy. PFS defined as time from the first day of study treatment to the day of a negative outcome (progression according to RECIST (Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, et al. New Guidelines to Evaluate the Response to Treatment in Solid Tumors. J Natl Cancer Inst 2000; 92:205-16) or death) or last contact. If any patient is lost to follow up before disease progression, the PFS will be censored at the date of the last tumor assessment. If there are no tumor assessments the patient will be censored at the first drug administration date.
Outcome measures
| Measure |
Aplidin®
n=8 Participants
Aplidin (Plitidepsin)
Aplidin (plitidepsin): Aplidin® administered at a starting dose of 5 mg/m2, as a 3-hours intravenous infusion, every 2 weeks.
|
|---|---|
|
Progression Free Survival (PFS)
|
1.76 months
Interval 1.4 to 3.2
|
SECONDARY outcome
Timeframe: All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured firstTo assess the antitumor activity of plitidepsin given intravenously over 3-hours every two weeks in patients with castrate metastatic adenocarcinoma of the prostate that have relapsed or progressed after two previous lines of systemic therapy, considering biological agents or chemotherapy as systemic therapy and taking into account that patients must have received prior docetaxel-based chemotherapy. Survival is measured from the first day of study treatment to death or day of their last follow-up
Outcome measures
| Measure |
Aplidin®
n=8 Participants
Aplidin (Plitidepsin)
Aplidin (plitidepsin): Aplidin® administered at a starting dose of 5 mg/m2, as a 3-hours intravenous infusion, every 2 weeks.
|
|---|---|
|
Overall Survival (OS)
|
8.0 months
Interval 5.7 to 9.8
|
SECONDARY outcome
Timeframe: 2-7 days for the pain stabilization required at baseline to ensure that baseline values are stable and reliable. The follow-up period was up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatmentTo assess the antitumor activity of plitidepsin given intravenously over 3-hours every two weeks in patients with castrate metastatic adenocarcinoma of the prostate that have relapsed or progressed after two previous lines of systemic therapy, considering biological agents or chemotherapy as systemic therapy and taking into account that patients must have received prior docetaxel-based chemotherapy. Expressed as a change in pain intensity according to the pain intensity score on the 100 mm VAS (Visual Analogue Scale) and/or change in analgesic (morphine-equivalent mg) requirements after a pain stabilization period of 2-7 days Visual Analogue Scale (VAS), expressed in the pain intensity score on the 100 mm VAS scale (0=least possible pain to 100=worst possible pain)
Outcome measures
| Measure |
Aplidin®
n=8 Participants
Aplidin (Plitidepsin)
Aplidin (plitidepsin): Aplidin® administered at a starting dose of 5 mg/m2, as a 3-hours intravenous infusion, every 2 weeks.
|
|---|---|
|
Pain Improvement Rate
|
0 units on a scale
Interval -81.8 to 60.0
|
SECONDARY outcome
Timeframe: From baseline until progression or initiation of another anticancer therapy, death or one year after the last treatment visit of the last patient, whichever occurred first.Population: One patient less because there were not PSA measurements after baseline
To assess the antitumor activity of plitidepsin given intravenously over 3-hours every two weeks in patients with castrate metastatic adenocarcinoma of the prostate that have relapsed or progressed after two previous lines of systemic therapy, considering biological agents or chemotherapy as systemic therapy and taking into account that patients must have received prior docetaxel-based chemotherapy. It was calculated as (nadir value-baseline value)/(nadir date-baseline date). Modifications in the slope of PSA changes before and after the start of treatment with Aplidin will also be explored.
Outcome measures
| Measure |
Aplidin®
n=7 Participants
Aplidin (Plitidepsin)
Aplidin (plitidepsin): Aplidin® administered at a starting dose of 5 mg/m2, as a 3-hours intravenous infusion, every 2 weeks.
|
|---|---|
|
PSA Slope Between Baseline PSA Value and Nadir After the Start of Treatment
|
1.3 ng/ml/days
Interval -1.9 to 23.8
|
Adverse Events
Aplidin®
Serious adverse events
| Measure |
Aplidin®
n=8 participants at risk
Aplidin (Plitidepsin)
Aplidin (plitidepsin): Aplidin® administered at a starting dose of 5 mg/m2, as a 3-hours intravenous infusion, every 2 weeks.
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
12.5%
1/8
|
|
Cardiac disorders
Atrioventricular block
|
12.5%
1/8
|
|
Cardiac disorders
Sinus arrhythmia
|
12.5%
1/8
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
12.5%
1/8
|
|
Investigations
Electrocardiogram ST-T change
|
12.5%
1/8
|
|
Investigations
Electrocardiogram abnormal
|
12.5%
1/8
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
1/8
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
12.5%
1/8
|
Other adverse events
| Measure |
Aplidin®
n=8 participants at risk
Aplidin (Plitidepsin)
Aplidin (plitidepsin): Aplidin® administered at a starting dose of 5 mg/m2, as a 3-hours intravenous infusion, every 2 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
37.5%
3/8
|
|
Blood and lymphatic system disorders
Leukocytosis
|
12.5%
1/8
|
|
Ear and labyrinth disorders
Ear pain
|
12.5%
1/8
|
|
Ear and labyrinth disorders
Tinnitus
|
12.5%
1/8
|
|
Eye disorders
Dry eye
|
12.5%
1/8
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8
|
|
Gastrointestinal disorders
Constipation
|
62.5%
5/8
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
4/8
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
1/8
|
|
Gastrointestinal disorders
Eructation
|
12.5%
1/8
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
12.5%
1/8
|
|
Gastrointestinal disorders
Nausea
|
100.0%
8/8
|
|
Gastrointestinal disorders
Stomatitis
|
12.5%
1/8
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
2/8
|
|
General disorders
Chest pain
|
12.5%
1/8
|
|
General disorders
Chills
|
12.5%
1/8
|
|
General disorders
Fatigue
|
100.0%
8/8
|
|
General disorders
Influenza like illness
|
12.5%
1/8
|
|
General disorders
Injection site reaction
|
12.5%
1/8
|
|
General disorders
Pain
|
12.5%
1/8
|
|
General disorders
Pyrexia
|
12.5%
1/8
|
|
General disorders
Thirst
|
12.5%
1/8
|
|
Infections and infestations
Herpes zoster
|
12.5%
1/8
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
4/8
|
|
Investigations
Aspartate aminotransferase increased
|
37.5%
3/8
|
|
Investigations
Blood alkaline phosphatase
|
25.0%
2/8
|
|
Investigations
Blood alkaline phosphatase increased
|
25.0%
2/8
|
|
Investigations
Blood creatine phosphokinase
|
12.5%
1/8
|
|
Investigations
Blood creatinine
|
25.0%
2/8
|
|
Investigations
Blood glucose
|
25.0%
2/8
|
|
Investigations
Blood lactate dehydrogenase increased
|
12.5%
1/8
|
|
Investigations
Electrocardiogram QT prolonged
|
37.5%
3/8
|
|
Investigations
Haemoglobin
|
12.5%
1/8
|
|
Investigations
Liver function test abnormal
|
12.5%
1/8
|
|
Investigations
Troponin increased
|
12.5%
1/8
|
|
Investigations
Weight decreased
|
50.0%
4/8
|
|
Metabolism and nutrition disorders
Anorexia
|
75.0%
6/8
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.5%
1/8
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
12.5%
1/8
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
37.5%
3/8
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
4/8
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
12.5%
1/8
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
12.5%
1/8
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
2/8
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
25.0%
2/8
|
|
Nervous system disorders
Dizziness
|
25.0%
2/8
|
|
Nervous system disorders
Dysgeusia
|
50.0%
4/8
|
|
Nervous system disorders
Headache
|
25.0%
2/8
|
|
Nervous system disorders
Hypoaesthesia
|
12.5%
1/8
|
|
Nervous system disorders
Neuropathy
|
12.5%
1/8
|
|
Nervous system disorders
Neuropathy peripheral
|
12.5%
1/8
|
|
Nervous system disorders
Sciatica
|
12.5%
1/8
|
|
Psychiatric disorders
Agitation
|
12.5%
1/8
|
|
Psychiatric disorders
Anxiety
|
25.0%
2/8
|
|
Psychiatric disorders
Claustrophobia
|
12.5%
1/8
|
|
Psychiatric disorders
Depression
|
12.5%
1/8
|
|
Psychiatric disorders
Insomnia
|
25.0%
2/8
|
|
Renal and urinary disorders
Bladder pain
|
12.5%
1/8
|
|
Renal and urinary disorders
Haematuria
|
12.5%
1/8
|
|
Renal and urinary disorders
Pollakiuria
|
12.5%
1/8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
12.5%
1/8
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
12.5%
1/8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
4/8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
12.5%
1/8
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
1/8
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
12.5%
1/8
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.5%
1/8
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
25.0%
2/8
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
12.5%
1/8
|
|
Vascular disorders
Flushing
|
12.5%
1/8
|
|
Vascular disorders
Ischaemia
|
12.5%
1/8
|
|
Vascular disorders
Orthostatic hypotension
|
12.5%
1/8
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.5%
1/8
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8
|
|
Renal and urinary disorders
Nocturia
|
12.5%
1/8
|
|
Renal and urinary disorders
Urinary incontinence
|
12.5%
1/8
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
12.5%
1/8
|
Additional Information
Clinical Development Department of PharmaMar´s Oncology,Business Unit.,
Pharma Mar, S.A.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60