Neoadjuvant Dupilumab in Men With Localized High-Risk Prostate Cancer

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03886493
• Collaborator: Regeneron Pharmaceuticals (Industry)
• Enrollment: 7
• Location: 1
• Arm: 1
• Actual Duration (Months): 13.3
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This is a single-center, single arm, open-label phase II study evaluating the safety, anti-tumor effect, and immunogenicity of neoadjuvant Dupixent given prior to radical prostatectomy.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Dupilumab	Phase 2

Detailed Description

This is a single-center, single arm, open-label phase II study evaluating the safety, anti-tumor effect, and immunogenicity of neoadjuvant Dupixent given prior to radical prostatectomy in men with high-risk localized prostate cancer (this trial will enroll men with at least high risk prostate cancer defined by NCCN Guidelines Version 2.2017 = clinical stage ≥T3a or PSA >20 ng/mL or Gleason score ≥8).

Patients will be recruited from the outpatient Urology clinic. Men will be treated with dupilumab 600 mg subcutaneously (SQ) on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints.

Follow-up evaluation for adverse events will occur 30 days and 60 days after surgery. Patients will then be followed by their urologists according to standard institutional practices, but will require PSA evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Men will be treated with dupilumab 600 mg s.q. on day 1, and then 300 mg s.q. on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. Fourteen days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints. Follow-up evaluation for adverse events will occur 30 days and 60 days after surgery. Patients will then be followed by their urologists according to standard institutional practices, but will require PSA evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.Men will be treated with dupilumab 600 mg s.q. on day 1, and then 300 mg s.q. on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. Fourteen days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints. Follow-up evaluation for adverse events will occur 30 days and 60 days after surgery. Patients will then be followed by their urologists according to standard institutional practices, but will require PSA evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Neoadjuvant Dupilumab in Men With Localized High-Risk Prostate Cancer
• Actual Study Start Date: Aug 28, 2019
• Actual Primary Completion Date: Oct 6, 2020
• Actual Study Completion Date: Oct 6, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dupixent Subcutaneous (SQ) Injection Participants will be treated with dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints.	Drug: Dupilumab; dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43.; Other Names: Dupixent

Outcome Measures

Primary Outcome Measures

1. Change in M2-TAM Infiltration From Baseline [change from baseline to up to 59 days post-intervention]

   Change in M2-TAM infiltration (number of macrophages / cell nuclei per high power field [hpf]) measured in pre- dupilumab biopsy to M2-TAM infiltration measured in post-dupilumab specimen collected at time of radical prostatectomy (up to 59 days post-intervention). Degree of TAM infiltration will be analyzed using immunohistochemical staining for CD206. It is hypothesized that a positive value will be associated with better outcome and a negative value will reflect a worse outcome.

Secondary Outcome Measures

1. Safety as Assessed by Number of Participants Experiencing Adverse Events [up to 59 days post-intervention]

   Adverse events defined by NCI Common Toxicity Criteria version 4.0 (NCI CTCAE v4.0)

2. Feasibility as Assessed by Number of Participants Who Have an Average Blood Loss in Excess of 2500 mL During Prostatectomy [up to 59 days post-intervention]

3. Feasibility as Assessed by Number of Participants With Average Prostatectomy Operative Time in Excess of 3.5 Hours [up to 59 days post-intervention]

4. Feasibility as Assessed by Number of Participants With Average Hospital Stay in Excess of 4 Days Post-prostatectomy [up to 59 days post-intervention]

5. CD8+ T-cell Infiltration in Post-treatment Prostate Glands [up to 59 days post-intervention]

   mean CD4+ T-cell staining percentage and CD4+/Treg ratio in harvested tumor tissue collected from prostatectomy specimen

6. CD4+ T-cell and Treg Infiltration in Post-treatment Prostate Glands [up to 59 days post-intervention]

   mean CD4+ T-cell staining percentage and CD4+/Treg ratio in harvested tumor tissue collected from prostatectomy specimen

7. Expression of Apoptosis Marker (Annexin V) in Post-treatment Prostate Tumor Specimen as Measured by Mean Staining Percentage in Tumor Tissue [up to 59 days post-intervention]

   Mean staining percentage of Annexin V in tumor tissue, using TUNEL (Terminal deoxynucleotidyl transferase dUTP nick end labeling) staining.

8. Expression of Cell Proliferation in Post-treatment Prostate Tumor Specimen as Measured by Mean Staining Percentage of Ki-67 in Tumor Tissue [up to 59 days post-intervention]

9. Proportion of Participants With Pathological Complete Response [1 month post-prostatectomy]

   Pathological response is defined as the absence of tumor identification by study pathologist on standard histological analysis of resected prostate specimens.

10. Proportion of Participants Who Achieve an Undetectable PSA at 2 Months Post-prostatectomy [2 months post-prostatectomy]

    Proportion of participants with PSA <0.1ng/mL by 2 months after prostatectomy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

To be eligible for this study, patients must meet all of the following criteria:

• Histologically confirmed adenocarcinoma of the prostate (clinical stage T1c-T3b, N0, M0) without involvement of lymph nodes, bone, or visceral organs

• Initial prostate biopsy is available for central pathologic review, and is confirmed to show at least 2 positive cores and a Gleason sum of ≥7

• Radical prostatectomy has been scheduled at Johns Hopkins Hospital

• Age ≥18 years

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1, or Karnofsky score ≥ 70%

• Adequate bone marrow, hepatic, and renal function:

• WBC >3,000 cells/mm3

• ANC >1,500 cells/mm3

• Hemoglobin >9.0 g/dL

• Platelet count >100,000 cells/mm3

• Serum creatinine <3 × upper limit of normal (ULN)

• Serum bilirubin <3 × ULN

• ALT <5 × ULN

• AST <5 × ULN

• Alkaline phosphatase <5 × ULN

• Willingness to provide written informed consent and HIPAA authorization for the release of personal health information, and the ability to comply with the study requirements (note: HIPAA authorization will be included in the informed consent)

• Willingness to use barrier contraception from the time of first dose of DUPILUMAB until the time of prostatectomy.

Exclusion Criteria:

To be eligible for this study, patients should not meet any of the following criteria:

• Presence of known lymph node involvement or distant metastases

• Other histologic types of prostate cancers such as ductal, sarcomatous, lymphoma, small cell, and neuroendocrine tumors

• Prior radiation therapy, hormonal therapy, biologic therapy, or chemotherapy for prostate cancer

• Prior immunotherapy/vaccine therapy for prostate cancer

• Concomitant treatment with other hormonal therapy or 5α-reductase inhibitors

• Current use of systemic corticosteroids or use of corticosteroids within 4 weeks of enrollment (inhaled corticosteroids for asthma or COPD are permitted)

• Use of experimental agents for prostate cancer within the past 3 months from time of screening

• History or presence of autoimmune disease requiring systemic immunosuppression (including but not limited to: inflammatory bowel disease, systemic lupus erythematosus, vasculitis, rheumatoid arthritis, scleroderma, multiple sclerosis, hemolytic anemia, Sjögren syndrome, and sarcoidosis)

• History of malignancy within the last 3 years, with the exception of non-melanoma skin cancers and superficial bladder cancer

• Uncontrolled major active infectious, cardiovascular, pulmonary, hematologic, or psychiatric illnesses that would make the patient a poor study candidate

• Known prior or current history of HIV and/or hepatitis B/C

• Significant eye disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland	United States	21228

Sponsors and Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Regeneron Pharmaceuticals

Investigators

• Principal Investigator: Kenneth Pienta, MD, Johns Hopkins University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 3, 2020

More Information

Publications

None provided.

• Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• ClinicalTrials.gov Identifier: NCT03886493
• Other Study ID Numbers: J18116; IRB00182718
• First Posted: Mar 22, 2019
• Last Update Posted: Oct 15, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: high-risk prostate cancer; localized prostate cancer; prior to prostatectomy; neoadjuvant
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Arm/Group Title	Dupixent Subcutaneous (SQ) Injection
Arm/Group Description	Participants will be treated with dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints. Dupilumab: dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43.
Period Title: Overall Study
STARTED	7
COMPLETED	6
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Dupixent Subcutaneous (SQ) Injection
Arm/Group Description	Participants will be treated with dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints. Dupilumab: dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43.
Overall Participants	7
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	5 71.4%
>=65 years	2 28.6%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	7 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	7 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 14.3%
White	6 85.7%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	7 100%

Outcome Measures

1. Primary Outcome

Title	Change in M2-TAM Infiltration From Baseline
Description	Change in M2-TAM infiltration (number of macrophages / cell nuclei per high power field [hpf]) measured in pre- dupilumab biopsy to M2-TAM infiltration measured in post-dupilumab specimen collected at time of radical prostatectomy (up to 59 days post-intervention). Degree of TAM infiltration will be analyzed using immunohistochemical staining for CD206. It is hypothesized that a positive value will be associated with better outcome and a negative value will reflect a worse outcome.
Time Frame	change from baseline to up to 59 days post-intervention

Outcome Measure Data

Analysis Population Description

Data could not be collected for this outcome measure due to COVID-19 pandemic restrictions.

Arm/Group Title	Dupixent Subcutaneous (SQ) Injection
Arm/Group Description	Participants will be treated with dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints. Dupilumab: dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43.
Measure Participants	0

2. Secondary Outcome

Title	Safety as Assessed by Number of Participants Experiencing Adverse Events
Description	Adverse events defined by NCI Common Toxicity Criteria version 4.0 (NCI CTCAE v4.0)
Time Frame	up to 59 days post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dupixent Subcutaneous (SQ) Injection
Arm/Group Description	Participants will be treated with dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints. Dupilumab: dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43.
Measure Participants	7
Count of Participants [Participants]	7 100%

3. Secondary Outcome

Title	Feasibility as Assessed by Number of Participants Who Have an Average Blood Loss in Excess of 2500 mL During Prostatectomy
Time Frame	up to 59 days post-intervention

Outcome Measure Data

Analysis Population Description

Only 6/7 participants had a prostatectomy.

Arm/Group Title	Dupixent Subcutaneous (SQ) Injection
Arm/Group Description	Participants will be treated with dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints. Dupilumab: dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43.
Measure Participants	6
Count of Participants [Participants]	0 0%

4. Secondary Outcome

Title	Feasibility as Assessed by Number of Participants With Average Prostatectomy Operative Time in Excess of 3.5 Hours
Time Frame	up to 59 days post-intervention

Outcome Measure Data

Analysis Population Description

Only 6/7 participants had a prostatectomy.

Arm/Group Title	Dupixent Subcutaneous (SQ) Injection
Arm/Group Description	Participants will be treated with dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints. Dupilumab: dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43.
Measure Participants	6
Count of Participants [Participants]	2 28.6%

5. Secondary Outcome

Title	Feasibility as Assessed by Number of Participants With Average Hospital Stay in Excess of 4 Days Post-prostatectomy
Time Frame	up to 59 days post-intervention

Outcome Measure Data

Analysis Population Description

Only 6/7 participants had a prostatectomy

Arm/Group Title	Dupixent Subcutaneous (SQ) Injection
Arm/Group Description	Participants will be treated with dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints. Dupilumab: dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43.
Measure Participants	6
Count of Participants [Participants]	0 0%

6. Secondary Outcome

Title	CD8+ T-cell Infiltration in Post-treatment Prostate Glands
Description	mean CD4+ T-cell staining percentage and CD4+/Treg ratio in harvested tumor tissue collected from prostatectomy specimen
Time Frame	up to 59 days post-intervention

Outcome Measure Data

Analysis Population Description

Data could not be collected for this outcome measure due to COVID-19 pandemic restrictions.

Arm/Group Title	Dupixent Subcutaneous (SQ) Injection
Arm/Group Description	Participants will be treated with dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints. Dupilumab: dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43.
Measure Participants	0

7. Secondary Outcome

Title	CD4+ T-cell and Treg Infiltration in Post-treatment Prostate Glands
Description	mean CD4+ T-cell staining percentage and CD4+/Treg ratio in harvested tumor tissue collected from prostatectomy specimen
Time Frame	up to 59 days post-intervention

Outcome Measure Data

Analysis Population Description

Data could not be collected for this outcome measure due to COVID-19 pandemic restrictions.

Arm/Group Title	Dupixent Subcutaneous (SQ) Injection
Arm/Group Description	Participants will be treated with dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints. Dupilumab: dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43.
Measure Participants	0

8. Secondary Outcome

Title	Expression of Apoptosis Marker (Annexin V) in Post-treatment Prostate Tumor Specimen as Measured by Mean Staining Percentage in Tumor Tissue
Description	Mean staining percentage of Annexin V in tumor tissue, using TUNEL (Terminal deoxynucleotidyl transferase dUTP nick end labeling) staining.
Time Frame	up to 59 days post-intervention

Outcome Measure Data

Analysis Population Description

Data could not be collected for this outcome measure due to COVID-19 pandemic restrictions.

Arm/Group Title	Dupixent Subcutaneous (SQ) Injection
Arm/Group Description	Participants will be treated with dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints. Dupilumab: dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43.
Measure Participants	0

9. Secondary Outcome

Title	Expression of Cell Proliferation in Post-treatment Prostate Tumor Specimen as Measured by Mean Staining Percentage of Ki-67 in Tumor Tissue
Time Frame	up to 59 days post-intervention

Outcome Measure Data

Analysis Population Description

Data could not be collected for this outcome measure due to COVID-19 pandemic restrictions.

Arm/Group Title	Dupixent Subcutaneous (SQ) Injection
Arm/Group Description	Participants will be treated with dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints. Dupilumab: dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43.
Measure Participants	0

10. Secondary Outcome

Title	Proportion of Participants With Pathological Complete Response
Description	Pathological response is defined as the absence of tumor identification by study pathologist on standard histological analysis of resected prostate specimens.
Time Frame	1 month post-prostatectomy

Outcome Measure Data

Analysis Population Description

Data could not be collected for this outcome measure due to COVID-19 pandemic restrictions.

Arm/Group Title	Dupixent Subcutaneous (SQ) Injection
Arm/Group Description	Participants will be treated with dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints. Dupilumab: dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43.
Measure Participants	0

11. Secondary Outcome

Title	Proportion of Participants Who Achieve an Undetectable PSA at 2 Months Post-prostatectomy
Description	Proportion of participants with PSA <0.1ng/mL by 2 months after prostatectomy
Time Frame	2 months post-prostatectomy

Outcome Measure Data

Analysis Population Description

Data could not be collected for this outcome measure due to COVID-19 pandemic restrictions.

Arm/Group Title	Dupixent Subcutaneous (SQ) Injection
Arm/Group Description	Participants will be treated with dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints. Dupilumab: dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43.
Measure Participants	0

Adverse Events

Time Frame	up to 1 year
Arm/Group Title	Dupixent Subcutaneous (SQ) Injection
Arm/Group Description	Participants will be treated with dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints. Dupilumab: dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43.
All Cause Mortality
	Dupixent Subcutaneous (SQ) Injection
	Affected / at Risk (%)	# Events
Total	0/7 (0%)
Serious Adverse Events
	Dupixent Subcutaneous (SQ) Injection
	Affected / at Risk (%)	# Events
Total	0/7 (0%)
Other (Not Including Serious) Adverse Events
	Dupixent Subcutaneous (SQ) Injection
	Affected / at Risk (%)	# Events
Total	7/7 (100%)
Blood and lymphatic system disorders
edema in right calf and ankle	1/7 (14.3%)	1
elevated hemoglobin	1/7 (14.3%)	1
Eye disorders
eye pain	1/7 (14.3%)	1
Gastrointestinal disorders
Bloating	1/7 (14.3%)	1
Constipation	1/7 (14.3%)	1
nausea	1/7 (14.3%)	1
toothache	1/7 (14.3%)	1
General disorders
Headache, intermittent	2/7 (28.6%)	2
Fatigue	2/7 (28.6%)	2
Vivid dreams	1/7 (14.3%)	1
Metabolism and nutrition disorders
hyperkalemia	2/7 (28.6%)	2
hypocalcemia	1/7 (14.3%)	1
hypoglycemia	1/7 (14.3%)	1
loss of appetite	1/7 (14.3%)	1
Renal and urinary disorders
Urinary incontinence	5/7 (71.4%)	5
Increased creatinine	1/7 (14.3%)	1
urinary retention	1/7 (14.3%)	1
Reproductive system and breast disorders
reproductive system disorder, other blood in ejaculate	1/7 (14.3%)	1
Respiratory, thoracic and mediastinal disorders
laryngeal inflammation	1/7 (14.3%)	1
Skin and subcutaneous tissue disorders
induration at injection site on abdomen	1/7 (14.3%)	1
maculo papular rash on abdomen	2/7 (28.6%)	2
pruritis at site of injection on abdomen	1/7 (14.3%)	1
Right AC bruising related to blood draw	1/7 (14.3%)	1
Skin ulceration upper lip	1/7 (14.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.