Trial Outcomes & Findings for Hormonal Therapy and Chemotherapy Followed by Prostatectomy in Patients With Prostate Cancer (NCT NCT02494713)

Last Updated: 2018-11-27

Results Overview

Pathologic response is defined by percentage of tumor burden remaining at time of prostate removal. Percentage of tumor burden is measured based on a pathologist's assessment of the prostate tissue removed and visual estimate of how much tumor there is in the prostate.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Day of prostate removal, which is about 5 months following the day participant signed consent.

Results posted on

2018-11-27

Participant Flow

Participant milestones

Participant milestones
Measure	ADT + Chemotherapy Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy. Degarelix: Subcutaneous injection, once/month for 4 months Doxorubicin: 20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5 Ketoconazole: 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5 Docetaxel: 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6 Estramustine: 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hormonal Therapy and Chemotherapy Followed by Prostatectomy in Patients With Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ADT + Chemotherapy n=4 Participants Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy. Degarelix: Subcutaneous injection, once/month for 4 months Doxorubicin: 20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5 Ketoconazole: 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5 Docetaxel: 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6 Estramustine: 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants
Region of Enrollment United States	4 Participants n=5 Participants
ECOG Performance Status 0	4 Participants n=5 Participants
ECOG Performance Status 1	0 Participants n=5 Participants
ECOG Performance Status 2	0 Participants n=5 Participants
ECOG Performance Status 3	0 Participants n=5 Participants
ECOG Performance Status 4	0 Participants n=5 Participants
ECOG Performance Status 5	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day of prostate removal, which is about 5 months following the day participant signed consent.

Outcome measures

Outcome measures
Measure	ADT + Chemotherapy n=4 Participants Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy. Degarelix: Subcutaneous injection, once/month for 4 months Doxorubicin: 20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5 Ketoconazole: 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5 Docetaxel: 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6 Estramustine: 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6
Efficacy as Measured by Pathologic Response	30 percentage of tumor burden remaining Interval 1.0 to 70.0

SECONDARY outcome

Timeframe: baseline

Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.

Outcome measures

Outcome measures
Measure	ADT + Chemotherapy n=4 Participants Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy. Degarelix: Subcutaneous injection, once/month for 4 months Doxorubicin: 20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5 Ketoconazole: 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5 Docetaxel: 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6 Estramustine: 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6
Efficacy as Measured by Prostate-specific Antigen (PSA) Levels	58.7 ng/mL Interval 44.7 to 77.4

SECONDARY outcome

Timeframe: Cycle 2 Day 1, about 8 weeks after treatment initiation (but before prostatectomy)

Outcome measures

Outcome measures
Measure	ADT + Chemotherapy n=4 Participants Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy. Degarelix: Subcutaneous injection, once/month for 4 months Doxorubicin: 20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5 Ketoconazole: 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5 Docetaxel: 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6 Estramustine: 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6
Efficacy as Measured by Prostate-specific Antigen (PSA) Levels	0.4 ng/mL Interval 0.1 to 2.9

SECONDARY outcome

Timeframe: Cycle 2 Day 57, about 16 weeks after treatment initiation (but before prostatectomy)

Outcome measures

Outcome measures
Measure	ADT + Chemotherapy n=4 Participants Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy. Degarelix: Subcutaneous injection, once/month for 4 months Doxorubicin: 20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5 Ketoconazole: 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5 Docetaxel: 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6 Estramustine: 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6
Efficacy as Measured by Prostate-specific Antigen (PSA) Levels	0.15 ng/mL Interval 0.01 to 2.0

SECONDARY outcome

Timeframe: Day 133, about 19 weeks after treatment initiation (but before prostatectomy)

Outcome measures

Outcome measures
Measure	ADT + Chemotherapy n=4 Participants Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy. Degarelix: Subcutaneous injection, once/month for 4 months Doxorubicin: 20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5 Ketoconazole: 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5 Docetaxel: 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6 Estramustine: 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6
Efficacy as Measured by Prostate-specific Antigen (PSA) Levels	0.055 ng/mL Interval 0.01 to 1.3

SECONDARY outcome

Timeframe: about 20 weeks after treatment initiation (day of prostatectomy)

Outcome measures

Outcome measures
Measure	ADT + Chemotherapy n=4 Participants Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy. Degarelix: Subcutaneous injection, once/month for 4 months Doxorubicin: 20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5 Ketoconazole: 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5 Docetaxel: 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6 Estramustine: 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6
Efficacy as Measured by Prostate-specific Antigen (PSA) Levels	0.01 ng/mL Interval 0.01 to 0.1

SECONDARY outcome

Timeframe: about 32 weeks after treatment initiation (about 12 weeks after prostatectomy)

Outcome measures

Outcome measures
Measure	ADT + Chemotherapy n=4 Participants Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy. Degarelix: Subcutaneous injection, once/month for 4 months Doxorubicin: 20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5 Ketoconazole: 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5 Docetaxel: 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6 Estramustine: 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6
Efficacy as Measured by Prostate-specific Antigen (PSA) Levels	0.01 ng/mL Interval 0.01 to 0.1

SECONDARY outcome

Timeframe: about 44 weeks after treatment initiation (about 24 weeks after prostatectomy)

Population: This data was only collected for 3 out of the 4 participants.

Outcome measures

Outcome measures
Measure	ADT + Chemotherapy n=3 Participants Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy. Degarelix: Subcutaneous injection, once/month for 4 months Doxorubicin: 20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5 Ketoconazole: 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5 Docetaxel: 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6 Estramustine: 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6
Efficacy as Measured by Prostate-specific Antigen (PSA) Levels	0.35 ng/mL Interval 0.2 to 0.5

SECONDARY outcome

Timeframe: about 68 weeks after treatment initiation (about 48 weeks after prostatectomy)

Population: This data was collected for only 3 out of the 4 participants.

Outcome measures

Outcome measures
Measure	ADT + Chemotherapy n=3 Participants Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy. Degarelix: Subcutaneous injection, once/month for 4 months Doxorubicin: 20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5 Ketoconazole: 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5 Docetaxel: 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6 Estramustine: 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6
Efficacy as Measured by Prostate-specific Antigen (PSA) Levels	0.1 ng/mL Interval 0.01 to 0.8

SECONDARY outcome

Timeframe: From the time the participant signs the informed consent until prostatectomy, an average of 5 months.

Population: This data was not collected for any participants.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline

The volume of the prostate tumor was measured by a radiologist's assessment of multiparametric prostate magnetic resonance imaging.

Outcome measures

Outcome measures
Measure	ADT + Chemotherapy n=4 Participants Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy. Degarelix: Subcutaneous injection, once/month for 4 months Doxorubicin: 20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5 Ketoconazole: 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5 Docetaxel: 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6 Estramustine: 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6
Efficacy as Measured by Volume of the Prostate Tumor as Assessed by Multiparametric Prostate Magnetic Resonance Imaging (mpMRI)	19.3 cc Interval 13.3 to 26.1

SECONDARY outcome

Timeframe: post treatment but prior to prostatectomy (about 25 days after the end of treatment)

The volume of the prostate tumor was measured by a radiologist's assessment of multiparametric prostate magnetic resonance imaging.

Outcome measures

Outcome measures
Measure	ADT + Chemotherapy n=4 Participants Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy. Degarelix: Subcutaneous injection, once/month for 4 months Doxorubicin: 20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5 Ketoconazole: 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5 Docetaxel: 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6 Estramustine: 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6
Efficacy as Measured by Volume of the Prostate Tumor as Assessed by Multiparametric Prostate Magnetic Resonance Imaging (mpMRI)	3.75 cc Interval 1.3 to 7.4

SECONDARY outcome

Timeframe: From the time participant first initiates ADT plus chemotherapy until participant's completion of neoadjuvant ADT plus chemotherapy.

Number of adverse events was measured as a count of all participant adverse events that occurred from the time participant first initiates ADT plus chemotherapy until participant's completion of neoadjuvant ADT plus chemotherapy.

Outcome measures

Outcome measures
Measure	ADT + Chemotherapy n=4 Participants Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy. Degarelix: Subcutaneous injection, once/month for 4 months Doxorubicin: 20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5 Ketoconazole: 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5 Docetaxel: 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6 Estramustine: 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6
Safety of Drug Regimen as Measured by Number of Adverse Events	119 adverse event

SECONDARY outcome

Timeframe: From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months

Number of adverse events was measured as a count of all participant adverse events that occurred from the time participant first initiates ADT plus chemotherapy until the participant was taken off-study or the study was stopped, an average of 20 months

Outcome measures

Outcome measures
Measure	ADT + Chemotherapy n=4 Participants Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy. Degarelix: Subcutaneous injection, once/month for 4 months Doxorubicin: 20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5 Ketoconazole: 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5 Docetaxel: 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6 Estramustine: 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6
Surgical Morbidity as Measured by Number of Adverse Events	119 adverse event

Adverse Events

ADT + Chemotherapy

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ADT + Chemotherapy n=4 participants at risk Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy. Degarelix: Subcutaneous injection, once/month for 4 months Doxorubicin: 20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5 Ketoconazole: 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5 Docetaxel: 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6 Estramustine: 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6
Eye disorders WATERY EYES	25.0% 1/4 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Gastrointestinal disorders BLOATING	50.0% 2/4 • Number of events 6 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Gastrointestinal disorders CONSTIPATION	75.0% 3/4 • Number of events 3 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Gastrointestinal disorders DIARRHEA	50.0% 2/4 • Number of events 4 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Gastrointestinal disorders DRY MOUTH	25.0% 1/4 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Gastrointestinal disorders DYSPEPSIA	25.0% 1/4 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Gastrointestinal disorders GASTROESOPHAGEAL REFLUX	50.0% 2/4 • Number of events 9 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Gastrointestinal disorders NAUSEA	75.0% 3/4 • Number of events 5 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Gastrointestinal disorders Vomiting	25.0% 1/4 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
General disorders BACK PAIN	25.0% 1/4 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
General disorders EDEMA LIMBS	75.0% 3/4 • Number of events 9 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
General disorders FATIGUE	100.0% 4/4 • Number of events 12 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
General disorders FLU LIKE SYMPTOM-ACHINESS	25.0% 1/4 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
General disorders INJECTION SITE REACTION	50.0% 2/4 • Number of events 3 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
General disorders MALAISE	25.0% 1/4 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
General disorders NON-CARDIAC CHEST PAIN	25.0% 1/4 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
General disorders PAIN	50.0% 2/4 • Number of events 3 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Infections and infestations INFECTIONS/INFESTATIONS, THRUSH	25.0% 1/4 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Injury, poisoning and procedural complications BRUISING - PORT A CATH SITE	50.0% 2/4 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Investigations ALANINE AMINOTRANSFERASE INCREASED	25.0% 1/4 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Metabolism and nutrition disorders HYPOPHOSPHATEMIA	75.0% 3/4 • Number of events 6 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL/CONNECTIVE TISSUE DISORDERS, MUSCLE ACHES	25.0% 1/4 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Musculoskeletal and connective tissue disorders MYALGIA	25.0% 1/4 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Musculoskeletal and connective tissue disorders GENERALIZED MUSCLE WEAKNESS	25.0% 1/4 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Nervous system disorders COGNITIVE DISTURBANCE	25.0% 1/4 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Nervous system disorders DIZZINESS	50.0% 2/4 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Nervous system disorders DYSGEUSIA	50.0% 2/4 • Number of events 4 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Nervous system disorders HEADACHE	25.0% 1/4 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Psychiatric disorders AGITATION	25.0% 1/4 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Psychiatric disorders INSOMNIA	50.0% 2/4 • Number of events 5 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Psychiatric disorders PSYCHIATRIC DISORDER, EMOTIONAL	25.0% 1/4 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Psychiatric disorders RESTLESSNESS	25.0% 1/4 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Reproductive system and breast disorders BREAST PAIN	25.0% 1/4 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Respiratory, thoracic and mediastinal disorders COUGH	50.0% 2/4 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Respiratory, thoracic and mediastinal disorders HICCUPS	25.0% 1/4 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	25.0% 1/4 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Respiratory, thoracic and mediastinal disorders POST NASAL DRIP	50.0% 2/4 • Number of events 3 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Respiratory, thoracic and mediastinal disorders SNEEZING	25.0% 1/4 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Skin and subcutaneous tissue disorders ALOPECIA	100.0% 4/4 • Number of events 4 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Skin and subcutaneous tissue disorders BULLOUS DERMATITIS	25.0% 1/4 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Skin and subcutaneous tissue disorders DRY SKIN	25.0% 1/4 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Skin and subcutaneous tissue disorders NAIL DISCOLORATION	25.0% 1/4 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Skin and subcutaneous tissue disorders SKIN/SQ TISSUE DISORDERS, PEELING OF SKIN AT PORT A CATH SITE	25.0% 1/4 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Vascular disorders FLUSHING	25.0% 1/4 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Vascular disorders HOT FLASHES	50.0% 2/4 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Psychiatric disorders PSYCHIATRIC DISORDER, ANGER	25.0% 1/4 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Skin and subcutaneous tissue disorders SKIN/SQ TISSUE DISORDERS, RIGHT HAND SKIN IRRITATION	50.0% 2/4 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.

Additional Information

Marka Lyons, Research Manager

The University of Texas Health Science Center at Houston

Phone: 713-500-6919

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place