Trial Outcomes & Findings for Stereotactic Body Radiation With Nelfinavir for Oligometastases (NCT NCT01728779)

Last Updated: 2021-07-12

Results Overview

To determine the 6-month Freedom From Local Progression rate (measured as a percentage of participants) in participants treated with radiosensitizer nelfinavir used concurrently with 15 Gy of stereotactic body radiation therapy (SBRT) delivered in 1 fraction in patients with oligometastatic disease. FFLP is defined as the percent of participants who were free from progression at the 6 month time point.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

38 participants

Primary outcome timeframe

6 months

Results posted on

2021-07-12

Participant Flow

A total of 38 patients were accrued between January 2014 and December 2015 with one who withdrew consent and 37 were included in the analysis.

Participant milestones

Participant milestones
Measure	Nelfinavir w/Stereotactic Body Radiation Therapy (SBRT) Patients with metastatic lesions of the lung, liver, or bone will be candidates for treatment. Within three weeks of the initial treatment planning, a 15 Gy dose (per lesion site) of SBRT will be administered. Prior to SBRT, patients will initiate Nelfinavir oral therapy twice daily for 7 days. Once SBRT is completed, the patient will repeat the same Nelfinavir therapy for an additional 7 days for a total of 14 days of treatment. Nelfinavir: Commercially available nelfinavir (1250 mg) will be administered orally twice daily for 14 days. Stereotactic Body Radiation (SBRT): 15 Gy dose (per lesion site) of SBRT will be administered
Overall Study STARTED	38
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Nelfinavir w/Stereotactic Body Radiation Therapy (SBRT) Patients with metastatic lesions of the lung, liver, or bone will be candidates for treatment. Within three weeks of the initial treatment planning, a 15 Gy dose (per lesion site) of SBRT will be administered. Prior to SBRT, patients will initiate Nelfinavir oral therapy twice daily for 7 days. Once SBRT is completed, the patient will repeat the same Nelfinavir therapy for an additional 7 days for a total of 14 days of treatment. Nelfinavir: Commercially available nelfinavir (1250 mg) will be administered orally twice daily for 14 days. Stereotactic Body Radiation (SBRT): 15 Gy dose (per lesion site) of SBRT will be administered
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Stereotactic Body Radiation With Nelfinavir for Oligometastases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nelfinavir w/Stereotactic Body Radiation Therapy (SBRT) n=37 Participants Patients with metastatic lesions of the lung, liver, or bone will be candidates for treatment. Within three weeks of the initial treatment planning, a 15 Gy dose (per lesion site) of SBRT will be administered. Prior to SBRT, patients will initiate Nelfinavir oral therapy twice daily for 7 days. Once SBRT is completed, the patient will repeat the same Nelfinavir therapy for an additional 7 days for a total of 14 days of treatment. Nelfinavir: Commercially available nelfinavir (1250 mg) will be administered orally twice daily for 14 days. Stereotactic Body Radiation (SBRT): 15 Gy dose (per lesion site) of SBRT will be administered
Age, Customized	65 years n=93 Participants
Sex: Female, Male Female	14 Participants n=93 Participants
Sex: Female, Male Male	23 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants
Race (NIH/OMB) White	32 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	37 Participants n=93 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Nelfinavir w/Stereotactic Body Radiation Therapy (SBRT) n=37 Participants Patients with metastatic lesions of the lung, liver, or bone will be candidates for treatment. Within three weeks of the initial treatment planning, a 15 Gy dose (per lesion site) of SBRT will be administered. Prior to SBRT, patients will initiate Nelfinavir oral therapy twice daily for 7 days. Once SBRT is completed, the patient will repeat the same Nelfinavir therapy for an additional 7 days for a total of 14 days of treatment. Nelfinavir: Commercially available nelfinavir (1250 mg) will be administered orally twice daily for 14 days. Stereotactic Body Radiation (SBRT): 15 Gy dose (per lesion site) of SBRT will be administered
Percentage of Participants With Freedom From Local Progression (FFLP)	78.4 percentage of participants Interval 61.4 to 88.5

SECONDARY outcome

Timeframe: 1 year

To assess the toxicity of the radiosensitizer Nelfinavir used concurrently with 15 Gy of stereotactic body radiation therapy (SBRT) delivered in 1 fraction (per lesion site) in patients with oligometastatic disease. Toxicity is assessed by the total number of adverse events based on Common Terminology Criteria for Adverse Events (CTCAE).

Outcome measures

Outcome measures
Measure	Nelfinavir w/Stereotactic Body Radiation Therapy (SBRT) n=37 Participants Patients with metastatic lesions of the lung, liver, or bone will be candidates for treatment. Within three weeks of the initial treatment planning, a 15 Gy dose (per lesion site) of SBRT will be administered. Prior to SBRT, patients will initiate Nelfinavir oral therapy twice daily for 7 days. Once SBRT is completed, the patient will repeat the same Nelfinavir therapy for an additional 7 days for a total of 14 days of treatment. Nelfinavir: Commercially available nelfinavir (1250 mg) will be administered orally twice daily for 14 days. Stereotactic Body Radiation (SBRT): 15 Gy dose (per lesion site) of SBRT will be administered
Total Number of Adverse Events Experienced by Participants Anorexia	20 adverse events
Total Number of Adverse Events Experienced by Participants Anxiety	17 adverse events
Total Number of Adverse Events Experienced by Participants Cough	25 adverse events
Total Number of Adverse Events Experienced by Participants Agitation	3 adverse events
Total Number of Adverse Events Experienced by Participants Alanine Amino Trans increased	3 adverse events
Total Number of Adverse Events Experienced by Participants Alkaline Phosphatase increased	4 adverse events
Total Number of Adverse Events Experienced by Participants Alopecia	8 adverse events
Total Number of Adverse Events Experienced by Participants ALT Increase	3 adverse events
Total Number of Adverse Events Experienced by Participants Anemia	23 adverse events
Total Number of Adverse Events Experienced by Participants Apnea	3 adverse events
Total Number of Adverse Events Experienced by Participants Aspartate Amino Trans increased	2 adverse events
Total Number of Adverse Events Experienced by Participants Ataxia	1 adverse events
Total Number of Adverse Events Experienced by Participants Bilirubin Increased	3 adverse events
Total Number of Adverse Events Experienced by Participants Bloating	6 adverse events
Total Number of Adverse Events Experienced by Participants Bronchial Infection	1 adverse events
Total Number of Adverse Events Experienced by Participants Bruising	7 adverse events
Total Number of Adverse Events Experienced by Participants Chills	6 adverse events
Total Number of Adverse Events Experienced by Participants Colonic obstruction	1 adverse events
Total Number of Adverse Events Experienced by Participants Concentration Impairment	7 adverse events
Total Number of Adverse Events Experienced by Participants Conjunctivitis	2 adverse events
Total Number of Adverse Events Experienced by Participants Constipation	18 adverse events
Total Number of Adverse Events Experienced by Participants Creatinine increased	1 adverse events
Total Number of Adverse Events Experienced by Participants Cytokine Release Syndrome	1 adverse events
Total Number of Adverse Events Experienced by Participants Dehydration	4 adverse events
Total Number of Adverse Events Experienced by Participants Depression	15 adverse events
Total Number of Adverse Events Experienced by Participants Dermatitis	1 adverse events
Total Number of Adverse Events Experienced by Participants Diarrhea	31 adverse events
Total Number of Adverse Events Experienced by Participants Dizziness	11 adverse events
Total Number of Adverse Events Experienced by Participants Dry Mouth	14 adverse events
Total Number of Adverse Events Experienced by Participants Dyspepsia	13 adverse events
Total Number of Adverse Events Experienced by Participants Dyspnea	25 adverse events
Total Number of Adverse Events Experienced by Participants Edema	21 adverse events
Total Number of Adverse Events Experienced by Participants Esophageal pain	3 adverse events
Total Number of Adverse Events Experienced by Participants Esophagitis	5 adverse events
Total Number of Adverse Events Experienced by Participants Fatigue	32 adverse events
Total Number of Adverse Events Experienced by Participants Fecal Incontinence	4 adverse events
Total Number of Adverse Events Experienced by Participants Fever	1 adverse events
Total Number of Adverse Events Experienced by Participants Gastritis	3 adverse events
Total Number of Adverse Events Experienced by Participants Headache	12 adverse events
Total Number of Adverse Events Experienced by Participants Hearing Loss	1 adverse events
Total Number of Adverse Events Experienced by Participants Hematuria	3 adverse events
Total Number of Adverse Events Experienced by Participants Hemaglobin Increased	3 adverse events
Total Number of Adverse Events Experienced by Participants Hemorrhoids	12 adverse events
Total Number of Adverse Events Experienced by Participants Hiccups	2 adverse events
Total Number of Adverse Events Experienced by Participants Hot Flashes	4 adverse events
Total Number of Adverse Events Experienced by Participants Hyperglycemia	32 adverse events
Total Number of Adverse Events Experienced by Participants Hyperkalemia	4 adverse events
Total Number of Adverse Events Experienced by Participants Hypernatremia	1 adverse events
Total Number of Adverse Events Experienced by Participants Hypertension	1 adverse events
Total Number of Adverse Events Experienced by Participants Hypoglycemia	2 adverse events
Total Number of Adverse Events Experienced by Participants Hypokalemia	2 adverse events
Total Number of Adverse Events Experienced by Participants Hyponatremia	1 adverse events
Total Number of Adverse Events Experienced by Participants Hypoxia	1 adverse events
Total Number of Adverse Events Experienced by Participants Insomnia	1 adverse events
Total Number of Adverse Events Experienced by Participants Lymphocyte absolute decreased	22 adverse events
Total Number of Adverse Events Experienced by Participants Malaise	2 adverse events
Total Number of Adverse Events Experienced by Participants Nausea	23 adverse events
Total Number of Adverse Events Experienced by Participants Neuralgia	12 adverse events
Total Number of Adverse Events Experienced by Participants White blood cells decreased	22 adverse events
Total Number of Adverse Events Experienced by Participants Weight Loss	10 adverse events
Total Number of Adverse Events Experienced by Participants Weight Gain	15 adverse events
Total Number of Adverse Events Experienced by Participants Vomitting	10 adverse events
Total Number of Adverse Events Experienced by Participants Urticaria	2 adverse events
Total Number of Adverse Events Experienced by Participants Urinary Incontinence	25 adverse events
Total Number of Adverse Events Experienced by Participants Urinary Frequency	2 adverse events
Total Number of Adverse Events Experienced by Participants Tremor	3 adverse events
Total Number of Adverse Events Experienced by Participants Toothache	2 adverse events
Total Number of Adverse Events Experienced by Participants Stomatitis	2 adverse events
Total Number of Adverse Events Experienced by Participants Stomach Pain	11 adverse events
Total Number of Adverse Events Experienced by Participants Oral mucositis	3 adverse events
Total Number of Adverse Events Experienced by Participants Perineal Pain	1 adverse events
Total Number of Adverse Events Experienced by Participants Periodontal Disease	1 adverse events
Total Number of Adverse Events Experienced by Participants Platelet count decreased	13 adverse events
Total Number of Adverse Events Experienced by Participants Proctitis	2 adverse events
Total Number of Adverse Events Experienced by Participants Pruritis	9 adverse events
Total Number of Adverse Events Experienced by Participants Radiation Recall Rctn	3 adverse events
Total Number of Adverse Events Experienced by Participants Rash	2 adverse events
Total Number of Adverse Events Experienced by Participants Skin Infection	1 adverse events
Total Number of Adverse Events Experienced by Participants Short term memory impairment	1 adverse events

SECONDARY outcome

Timeframe: 6 months

To determine percent of lesions with local control at 6-months after SBRT delivered to a dose of 15 Gy in 1 fraction (per lesion site) combined with nelfinavir in patients with oligometastatic disease.

Outcome measures

Outcome measures
Measure	Nelfinavir w/Stereotactic Body Radiation Therapy (SBRT) n=68 Lesions Patients with metastatic lesions of the lung, liver, or bone will be candidates for treatment. Within three weeks of the initial treatment planning, a 15 Gy dose (per lesion site) of SBRT will be administered. Prior to SBRT, patients will initiate Nelfinavir oral therapy twice daily for 7 days. Once SBRT is completed, the patient will repeat the same Nelfinavir therapy for an additional 7 days for a total of 14 days of treatment. Nelfinavir: Commercially available nelfinavir (1250 mg) will be administered orally twice daily for 14 days. Stereotactic Body Radiation (SBRT): 15 Gy dose (per lesion site) of SBRT will be administered
Percent of Lesions With Local Control at 6 Months Post-treatment	76.5 percentage of lesions Interval 64.5 to 84.9

SECONDARY outcome

Timeframe: 18 months

To assess the long-term clinical outcomes of this patient population after completion of SBRT in combination with Nelfinavir by determining the percentage of participants with Overall Survival (OS), Freedom From Distant Metastasis (FFDM) and the Progression-Free Survival (PFS).

Outcome measures

Outcome measures
Measure	Nelfinavir w/Stereotactic Body Radiation Therapy (SBRT) n=37 Participants Patients with metastatic lesions of the lung, liver, or bone will be candidates for treatment. Within three weeks of the initial treatment planning, a 15 Gy dose (per lesion site) of SBRT will be administered. Prior to SBRT, patients will initiate Nelfinavir oral therapy twice daily for 7 days. Once SBRT is completed, the patient will repeat the same Nelfinavir therapy for an additional 7 days for a total of 14 days of treatment. Nelfinavir: Commercially available nelfinavir (1250 mg) will be administered orally twice daily for 14 days. Stereotactic Body Radiation (SBRT): 15 Gy dose (per lesion site) of SBRT will be administered
Participants' Clinical Progress While in Follow-up in Terms of Survival Overall Survival	90.7 percentage of participants Interval 73.8 to 96.9
Participants' Clinical Progress While in Follow-up in Terms of Survival Freedom From Distant Metastasis	62.4 percentage of participants Interval 43.9 to 76.3
Participants' Clinical Progress While in Follow-up in Terms of Survival Progression-Free Survival	57.6 percentage of participants Interval 39.7 to 72.0

SECONDARY outcome

Timeframe: 3 years

Population: Data was not collected for this outcome measure.

To assess quality of life following completion of SBRT in combination with nelfinavir

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Data was not collected for this outcome measure.

Assess phospho-Akt protein in study participants to determine whether there is a correlation between the level protein and improved lesion response rate.

Outcome measures

Outcome data not reported

Adverse Events

Nelfinavir w/Stereotactic Body Radiation Therapy (SBRT)

Serious events: 3 serious events

Other events: 37 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Nelfinavir w/Stereotactic Body Radiation Therapy (SBRT) n=37 participants at risk Patients with metastatic lesions of the lung, liver, or bone will be candidates for treatment. Within three weeks of the initial treatment planning, a 15 Gy dose (per lesion site) of SBRT will be administered. Prior to SBRT, patients will initiate Nelfinavir oral therapy twice daily for 7 days. Once SBRT is completed, the patient will repeat the same Nelfinavir therapy for an additional 7 days for a total of 14 days of treatment. Nelfinavir: Commercially available nelfinavir (1250 mg) will be administered orally twice daily for 14 days. Stereotactic Body Radiation (SBRT): 15 Gy dose (per lesion site) of SBRT will be administered
Psychiatric disorders Anxiety	2.7% 1/37 • Number of events 1 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Respiratory, thoracic and mediastinal disorders Cough	2.7% 1/37 • Number of events 1 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Gastrointestinal disorders Nausea	2.7% 1/37 • Number of events 1 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Gastrointestinal disorders Anorexia	2.7% 1/37 • Number of events 1 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Gastrointestinal disorders Weight Loss	2.7% 1/37 • Number of events 1 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.

Other adverse events

Other adverse events
Measure	Nelfinavir w/Stereotactic Body Radiation Therapy (SBRT) n=37 participants at risk Patients with metastatic lesions of the lung, liver, or bone will be candidates for treatment. Within three weeks of the initial treatment planning, a 15 Gy dose (per lesion site) of SBRT will be administered. Prior to SBRT, patients will initiate Nelfinavir oral therapy twice daily for 7 days. Once SBRT is completed, the patient will repeat the same Nelfinavir therapy for an additional 7 days for a total of 14 days of treatment. Nelfinavir: Commercially available nelfinavir (1250 mg) will be administered orally twice daily for 14 days. Stereotactic Body Radiation (SBRT): 15 Gy dose (per lesion site) of SBRT will be administered
Psychiatric disorders Anorexia	51.4% 19/37 • Number of events 19 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Psychiatric disorders Anxiety	43.2% 16/37 • Number of events 16 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Respiratory, thoracic and mediastinal disorders cough	64.9% 24/37 • Number of events 24 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
General disorders Alopecia	21.6% 8/37 • Number of events 8 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Blood and lymphatic system disorders Anemia	59.5% 22/37 • Number of events 22 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Renal and urinary disorders Bilirubin	24.3% 9/37 • Number of events 9 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Gastrointestinal disorders Bloating	16.2% 6/37 • Number of events 6 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
General disorders Bruising	18.9% 7/37 • Number of events 7 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
General disorders Chills	16.2% 6/37 • Number of events 6 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Nervous system disorders Concentration impairment	18.9% 7/37 • Number of events 7 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Gastrointestinal disorders Constipation	48.6% 18/37 • Number of events 18 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Psychiatric disorders Depression	40.5% 15/37 • Number of events 15 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Gastrointestinal disorders Diarrhea	97.3% 36/37 • Number of events 36 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
General disorders Dehydration	10.8% 4/37 • Number of events 4 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Nervous system disorders Dizziness	29.7% 11/37 • Number of events 11 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
General disorders Dry mouth	37.8% 14/37 • Number of events 14 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Gastrointestinal disorders Dyspepsia	35.1% 13/37 • Number of events 13 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
General disorders Dyspenea	67.6% 25/37 • Number of events 25 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
General disorders Edema	56.8% 21/37 • Number of events 21 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Respiratory, thoracic and mediastinal disorders Esophogitis	13.5% 5/37 • Number of events 5 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
General disorders Fatigue	100.0% 37/37 • Number of events 37 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Gastrointestinal disorders Fecal Incontinence	10.8% 4/37 • Number of events 4 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Nervous system disorders Headache	32.4% 12/37 • Number of events 12 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Gastrointestinal disorders Hemmorhoids	32.4% 12/37 • Number of events 12 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Endocrine disorders Hot Flashes	10.8% 4/37 • Number of events 4 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Endocrine disorders Hyperglycemia	86.5% 32/37 • Number of events 32 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Blood and lymphatic system disorders Hyperkalemia	10.8% 4/37 • Number of events 4 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Blood and lymphatic system disorders Lymphocyte Absolute Increase	100.0% 37/37 • Number of events 37 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Gastrointestinal disorders Nausea	59.5% 22/37 • Number of events 22 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Nervous system disorders Neuralgia	32.4% 12/37 • Number of events 12 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Blood and lymphatic system disorders WBC Decrease	59.5% 22/37 • Number of events 22 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Gastrointestinal disorders Vomitting	27.0% 10/37 • Number of events 10 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
General disorders Weight Loss	24.3% 9/37 • Number of events 9 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
General disorders Weight Increase	40.5% 15/37 • Number of events 15 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Renal and urinary disorders Urinary Incontinence	67.6% 25/37 • Number of events 25 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
General disorders Stomach Pain	29.7% 11/37 • Number of events 11 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
Blood and lymphatic system disorders Platelet Count Decrease	35.1% 13/37 • Number of events 13 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.
General disorders Pruritis	24.3% 9/37 • Number of events 9 • Up to 36 months. All AEs were recorded throughout the study, however there were only 5 grade 3 adverse events in three patients as defined by CTCAE.

Additional Information

Dana Kaplin

Johns Hopkins University

Phone: 410-614-3950

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place