Trial Outcomes & Findings for Phenelzine Sulfate and Docetaxel in Treating Patients With Prostate Cancer With Progressive Disease After First-Line Therapy With Docetaxel (NCT NCT01253642)
NCT ID: NCT01253642
Last Updated: 2019-10-02
Results Overview
PSA response: A ≥ 30% reduction from baseline within 12 weeks of initiation of therapy (confirmed on a second measurement at least 3 weeks later).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Within 12 weeks
Results posted on
2019-10-02
Participant Flow
Participant milestones
| Measure |
Combination Phenelzine and Docetaxel
Patients receive phenelzine sulfate orally (PO) once daily (QD) on days -7 to -4, and then twice daily (BID) on days -3 to 21. Patients receive docetaxel intravenously (IV) over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Overall Study
STARTED
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11
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Overall Study
COMPLETED
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6
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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
Phenelzine Sulfate and Docetaxel in Treating Patients With Prostate Cancer With Progressive Disease After First-Line Therapy With Docetaxel
Baseline characteristics by cohort
| Measure |
Combination Phenelzine and Docetaxel
n=11 Participants
Patients receive phenelzine sulfate PO QD on days -7 to -4, and then BID on days -3 to 21. Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Age, Continuous
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68 years
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
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
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Region of Enrollment
United States
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11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 12 weeksPSA response: A ≥ 30% reduction from baseline within 12 weeks of initiation of therapy (confirmed on a second measurement at least 3 weeks later).
Outcome measures
| Measure |
Combination Phenelzine and Docetaxel
n=11 Participants
Patients receive phenelzine sulfate PO QD on days -7 to -4, and then BID on days -3 to 21. Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Proportion of Patients Who Experience a PSA (Prostate-Specific Antigen) Decline of at Least 30%
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2 Participants
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SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: 1 subject withdrew from the study before the first evidence of progression and is not included in this progression free survival analysis.
Progression free survival is calculated as the time from Day 1 of Combination therapy to first evidence of progression (by PSA, Measureable Disease, or Clinical Progression). For subjects who did not meet progression criteria, date of new therapy or date of death was used. Outcome is reported as mean.
Outcome measures
| Measure |
Combination Phenelzine and Docetaxel
n=10 Participants
Patients receive phenelzine sulfate PO QD on days -7 to -4, and then BID on days -3 to 21. Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
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|---|---|
|
Duration of Progression Free Survival After Initiation of Combination Phenelzine and Docetaxel Therapy
|
77.9 days
Interval 57.0 to 99.0
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SECONDARY outcome
Timeframe: BaselinePopulation: Subjects who had evaluable samples collected immediately prior to initiation of Combination Therapy. 3 subjects did not have evaluable samples and were not included in this analysis.
Reported as Number of participants with MAOA expression greater than 5%.
Outcome measures
| Measure |
Combination Phenelzine and Docetaxel
n=8 Participants
Patients receive phenelzine sulfate PO QD on days -7 to -4, and then BID on days -3 to 21. Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Frequency of MAOA (Monoamine Oxidase A) Overexpression in CRPC (Castration-Resistant Prostate Cancer) Tumors That Are Progressing on Docetaxel
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8 Participants
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SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Of eleven subjects, CTC samples were collected from only 3. No testing was conducted on these 3 samples.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Of eleven subjects, CTC samples were collected from only 3. No testing was conducted on these 3 samples.
A Pearson's correlation will be used to correlate tumor biopsy MAOA expression and circulating tumor cells MAOA expression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeks (or earlier in patients who discontinued early)Population: 1 subject withdrew from the study before reaching 12 weeks and is not included in this progression free survival analysis.
Measured from Day 1 of Combination therapy to PSA at 12 Weeks on therapy (or earlier if subject not on therapy for 12 weeks).
Outcome measures
| Measure |
Combination Phenelzine and Docetaxel
n=10 Participants
Patients receive phenelzine sulfate PO QD on days -7 to -4, and then BID on days -3 to 21. Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Maximum Change in PSA
|
14.24 percentage of PSA change
Interval -46.56 to 69.94
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SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: 3 subjects were excluded from this response rate calculation as they did not have additional scans beyond baseline.
Response in measurable disease is defined as a 30% decrease in the sum of diameters of target lesions (as described by RECIST 1.1).
Outcome measures
| Measure |
Combination Phenelzine and Docetaxel
n=8 Participants
Patients receive phenelzine sulfate PO QD on days -7 to -4, and then BID on days -3 to 21. Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Response Rate in Measurable Disease by RECIST (Response Evaluation Criteria In Solid Tumors) Criteria
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0 Participants
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SECONDARY outcome
Timeframe: Up to 6 yearsTime to death is calculated from Day 1 of Combination therapy to death from any cause.
Outcome measures
| Measure |
Combination Phenelzine and Docetaxel
n=11 Participants
Patients receive phenelzine sulfate PO QD on days -7 to -4, and then BID on days -3 to 21. Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Time to Death From All Causes
|
191.0 days
Interval 99.0 to 621.0
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SECONDARY outcome
Timeframe: Up to 6 yearsNumber of participants who experienced an Adverse Event. Detail of Adverse Events is reported in the Adverse Event Section
Outcome measures
| Measure |
Combination Phenelzine and Docetaxel
n=11 Participants
Patients receive phenelzine sulfate PO QD on days -7 to -4, and then BID on days -3 to 21. Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Toxicity of the Regimen
|
11 Participants
|
Adverse Events
Combination Phenelzine and Docetaxel
Serious events: 1 serious events
Other events: 11 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Combination Phenelzine and Docetaxel
n=11 participants at risk
Patients receive phenelzine sulfate orally (PO) once daily (QD) on days -7 to -4, and then twice daily (BID) on days -3 to 21. Patients receive docetaxel intravenously (IV) over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
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|---|---|
|
General disorders
Sudden Death
|
9.1%
1/11 • Number of events 11 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
Other adverse events
| Measure |
Combination Phenelzine and Docetaxel
n=11 participants at risk
Patients receive phenelzine sulfate orally (PO) once daily (QD) on days -7 to -4, and then twice daily (BID) on days -3 to 21. Patients receive docetaxel intravenously (IV) over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
18.2%
2/11 • Number of events 2 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Blood and lymphatic system disorders
Anemia
|
18.2%
2/11 • Number of events 2 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Eye disorders
visual disturbance
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
General disorders
Fatigue
|
45.5%
5/11 • Number of events 5 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
General disorders
Edema (bilateral extremity)
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
General disorders
Irritability
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Gastrointestinal disorders
Constipation
|
18.2%
2/11 • Number of events 2 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Gastrointestinal disorders
Diarrhea
|
27.3%
3/11 • Number of events 3 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Gastrointestinal disorders
Mucositis
|
18.2%
2/11 • Number of events 2 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Infections and infestations
Sepsis
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Infections and infestations
Thrush, oral
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Investigations
Weight gain
|
18.2%
2/11 • Number of events 2 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Metabolism and nutrition disorders
Anorexia
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
18.2%
2/11 • Number of events 2 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain, back
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst, neck
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Nervous system disorders
Dizziness
|
18.2%
2/11 • Number of events 2 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Nervous system disorders
Syncope
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Nervous system disorders
Concentration Impairment
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Nervous system disorders
Sedation
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Nervous system disorders
Pre-syncope
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Nervous system disorders
Dysgeusia
|
18.2%
2/11 • Number of events 2 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Nervous system disorders
Memory Loss
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Nervous system disorders
Neuropathy
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Psychiatric disorders
Anxiety
|
18.2%
2/11 • Number of events 2 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Psychiatric disorders
Confusion
|
27.3%
3/11 • Number of events 3 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.2%
2/11 • Number of events 2 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Skin and subcutaneous tissue disorders
Rash (torso)
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
18.2%
2/11 • Number of events 2 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
18.2%
2/11 • Number of events 2 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Vascular disorders
Thromboembolic event
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Vascular disorders
Hypertention
|
27.3%
3/11 • Number of events 3 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Vascular disorders
Orthostatic hypotension
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
|
|
Vascular disorders
Deep vein thrombosis
|
9.1%
1/11 • Number of events 1 • Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events. Only Adverse Events that are considered possibly or definitely related to the study are reported.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place