Pembrolizumab and Enobosarm in Treating Patients With Androgen Receptor Positive Metastatic Triple Negative Breast Cancer
Study Details
Study Description
Brief Summary
This phase II trial studies the side effects and how well pembrolizumab and enobosarm work in treating patients with androgen receptor positive triple negative breast cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Androgen can cause the growth of breast cancer cells. Hormone therapy using enobosarm may fight breast cancer by blocking the use of androgen by the tumor cells. Giving pembrolizumab and enobosarm may work better than pembrolizumab alone in treating patients with androgen receptor positive triple negative breast cancer.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
PRIMARY OBJECTIVES:
- To evaluate the safety/tolerability of the combination regimen. II. To determine the response rate (complete response [CR] or partial response [PR] via Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) of the combination of pembrolizumab with enobosarm (GTx-024) in patients with advanced androgen receptor (AR) positive (+) triple negative breast cancer (TNBC).
SECONDARY OBJECTIVES:
-
To evaluate clinical outcomes by RECIST 1.1 including clinical benefit rate (CBR) at 24 weeks, progression free-survival (PFS), duration of response (DOR), event free survival (EFS), time-to-treatment failure (TTF); and overall survival (OS).
-
To evaluate the role of immune-related response criteria (irRECIST). III. To evaluate the association of AR by immunohistochemistry (IHC) and clinical response.
EXPLORATORY OBJECTIVES:
-
To evaluate the association of an AR gene expression signature and clinical response.
-
To evaluate genomic and phenotypic status of breast tumor. III. To evaluate the effect of the combination therapy on peripheral blood circulating tumor cells (CTCs) and circulating tumor deoxyribonucleic acid (DNA) (ctDNA).
-
To evaluate the effect of combination therapy on tumor-derived exosomes (TEX) and TEX associated immune biomarkers.
V. Immune correlatives:
Va. To evaluate pre-treatment programmed death ligand 1 (PD-L1) and tumor infiltrating lymphocytes (TILs) as a predictor of response to combination therapy.
Vb. To evaluate specific TIL subsets (e.g. CD4, CD8, regulatory T cell [Treg] distribution) and other immunological correlatives (e.g. T cell receptor [TCR] repertoire analysis) as possible predictors of response.
Vc. To evaluate change in TILs as a result of the combination therapy. Vd. To evaluate peripheral blood, immune biomarkers.
OUTLINE:
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and enobosarm orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 and 90 days, every 3 months, and bi-annually.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Treatment (pembrolizumab, enobosarm) Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. |
Drug: Enobosarm
Given PO
Other Names:
Other: Laboratory Biomarker Analysis
Correlative studies
Biological: Pembrolizumab
Given IV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Response Rate (Complete Response or Partial Response) [Up to 36 months]
Response rate (complete response or partial response) assessed using Response Evaluation Criteria in Solid Tumors version 1.1.
Secondary Outcome Measures
- Progression-free Survival [Time to disease progression/relapse or death as a result of any cause, assessed up to 36 months]
Progression-free survival assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Kaplan-Meier estimates will be generated.
- Clinical Benefit Rate [At 16 weeks]
Clinical benefit rate assessed by immune-related Response Evaluation Criteria in Solid Tumors version 1.1.
- Overall Survival [Time to death as a result of any cause, assessed up to 36 months]
Overall survival assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Kaplan-Meier estimates will be generated.
- Progression-free Survival [Up to 1 year]
Progression-free survival defined as failure of treatment or death as a result of any cause assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Kaplan-Meier estimates will be generated.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Documented informed consent
-
Willing to provide a sample from a recently obtained (within 42 days prior to initiation of day 1) biopsy of a tumor lesion
-
If recently-obtained samples are unavailable an archived metastatic specimen not previously irradiated may be submitted upon agreement from the study principal investigator (PI)
-
Eastern Cooperative Oncology Group (ECOG) performance status of =< 1
-
Life expectancy of > 3 months
-
Metastatic triple negative breast cancer (TNBC)
-
Measurable disease per RECIST version (v)1.1 criteria: at least 1 lesion of > 10 mm in long axis diameter for non-lymph nodes or > 15 mm in short axis diameter for lymph nodes that is serially measurable according to RECIST 1.1 using computerized tomography, magnetic resonance imaging, or panoramic and close-up color photography
-
Histologically proven diagnosis of TNBC per current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline
-
Estrogen receptor (ER) negative (ER expression =< 10% positive tumor nuclei), progesterone receptor (PR) negative (PR expression =< 10% positive tumor nuclei) and HER2 negative breast cancer by IHC and /or fluorescence in situ hybridization (FISH)
-
Androgen receptor positive (AR+)
-
Defined as >= 50% nuclear AR staining by immunohistochemistry (IHC) in either the primary or metastatic lesion
-
NOTE: research testing of AR status is available at City of Hope (COH) Pathology
-
Resolution of grade 2 and above toxicities of most recent therapy except for stable sensory neuropathy (=< grade 2) and alopecia
-
Female (childbearing potential): use an adequate method of birth control (except hormonal contraception) or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication
-
Childbearing potential defined as not being surgically sterilized or have not been free from menses for > 1 year
-
Male: use and adequate method of contraception with the first dose of study therapy through 120 days after the last dose of study therapy
-
Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
-
Absolute neutrophil count (ANC) >= 1500/mm^3 (within 14 days prior to day 1 of protocol therapy)
-
Platelets >= 100,000/mm^3 (within 14 days prior to day 1 of protocol therapy)
-
Hemoglobin >= 9 g/dL or >= 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment) (within 14 days prior to day 1 of protocol therapy)
-
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< ULN if total bilirubin levels > 1.5 x ULN (within 14 days prior to day 1 of protocol therapy)
-
Albumin >= 2.5 mg/dL (within 14 days prior to day 1 of protocol therapy)
-
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN OR =< 5.0 x ULN if liver metastases present (within 14 days prior to day 1 of protocol therapy)
-
Serum creatinine =< 1.5 x ULN OR creatinine clearance (if measured or calculated per institutional standard; glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) >= 60 mL/min if creatinine levels > 1.5 x ULN (within 14 days prior to day 1 of protocol therapy)
-
Female of childbearing potential only: negative urine or serum pregnancy test; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (within 14 days prior to day 1 of protocol therapy)
Exclusion Criteria:
-
Anti-programmed cell death protein-1 (anti-PD-1), PD ligand-1 (PD-L1), PD ligand-2 (PD-L2) agent, an antibody targeting other immuno-regulatory receptors or mechanisms
-
Radiotherapy within 14 days prior to day 1 of protocol therapy
-
AR targeted agents (including GTx-024, enzalutamide or other AR targeted therapies)
-
Investigational agent within 21 days prior to day 1 of protocol therapy
-
Hormone replacement therapies (estrogens, megestrol acetate) within 14 days prior to day 1 of protocol therapy
-
Live-virus vaccination within 30 days prior to day 1 of protocol therapy
-
Systemic cytotoxic chemotherapy, antineoplastic biologic therapy, or major surgery within 21 days of the first dose of trial medication
-
Testosterone or testosterone-like agents (methyltestosterone, oxandrolone, oxymetholone, danazol, fluoxymesterone, dehydroepiandrosterone, androstenedione) other androgenic compounds or anti-androgens within 30 days prior to day 1 of protocol therapy
-
Chronic systemic steroid therapy or on any other form of immunosuppressive medication
-
Unstable or untreated brain/leptomeningeal metastasis
-
Clinically active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, or abdominal carcinomatosis (known risks factors for bowel perforation)
-
Active central nervous system metastases and/or carcinomatous meningitis
-
Severe hypersensitivity reaction to treatment with another monoclonal antibody
-
Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapies for hormone deficiencies are allowed)
-
Known history of human immunodeficiency virus (HIV), hepatitis B or hepatitis C
-
History of pneumonitis (non-infectious) that required steroids or current pneumonitis
-
Diagnosed with or treated for cancer within the previous two years, other than breast cancer or non-melanoma carcinoma of the skin
-
Unable to swallow capsules
-
Currently on bisphosphonate or denosumab with elevated serum calcium levels corrected for albumin/ionized calcium levels outside of institutional normal limits
-
Female: pregnant or lactating
-
Concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases subject risk, in the opinion of the investigator, such as but not limited to:
-
Myocardial infarction or arterial thromboembolic events within 6 months prior to baseline or severe or unstable angina, New York Heart Association (NYHA) class III or IV disease, or a QTCB (corrected according to Bazett's formula) interval > 470 msec; serious uncontrolled cardiac arrhythmia grade II or higher according to NYHA; uncontrolled hypertension (systolic > 150 and/or diastolic > 100 mm Hg)
-
Acute and chronic active infectious disorders and non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy
-
Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)
-
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | City of Hope Corona | Corona | California | United States | 92879 |
2 | City of Hope Medical Center | Duarte | California | United States | 91010 |
3 | City of Hope Antelope Valley | Lancaster | California | United States | 93534 |
4 | City of Hope Mission Hills | Mission Hills | California | United States | 91345 |
5 | City of Hope Rancho Cucamonga | Rancho Cucamonga | California | United States | 91730 |
6 | City of Hope South Pasadena | South Pasadena | California | United States | 91030 |
7 | City of Hope West Covina | West Covina | California | United States | 91790 |
Sponsors and Collaborators
- City of Hope Medical Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Yuan Yuan, City of Hope Medical Center
Study Documents (Full-Text)
More Information
Publications
None provided.- 16131
- NCI-2016-01759
- 16131
Study Results
Participant Flow
Recruitment Details | Patients seen at the City of Hope main campus and its surrounding affiliated community clinics. |
---|---|
Pre-assignment Detail | Study was conducted from June 1, 2017 to October 28, 2019. |
Arm/Group Title | Treatment (Pembrolizumab, Enobosarm) |
---|---|
Arm/Group Description | Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Enobosarm: Given PO Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV |
Period Title: Overall Study | |
STARTED | 18 |
COMPLETED | 16 |
NOT COMPLETED | 2 |
Baseline Characteristics
Arm/Group Title | Treatment (Pembrolizumab, Enobosarm) |
---|---|
Arm/Group Description | Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Enobosarm: Given PO Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV |
Overall Participants | 16 |
Age (years) [Median (Full Range) ] | |
Median (Full Range) [years] |
64
|
Sex: Female, Male (Count of Participants) | |
Female |
16
100%
|
Male |
0
0%
|
Race/Ethnicity, Customized (Count of Participants) | |
non-Hispanic White |
8
50%
|
Hispanic |
5
31.3%
|
Asian |
2
12.5%
|
African American |
1
6.3%
|
Region of Enrollment (participants) [Number] | |
United States |
16
100%
|
Number of previous lines of therapy (Count of Participants) | |
Received 0-1 previous lines of therapy |
9
56.3%
|
Received >=2 previous lines of therapy |
7
43.8%
|
Performance Status (ECOG) (Count of Participants) | |
ECOG stage 0 |
7
43.8%
|
ECOG stage 1 |
9
56.3%
|
Nottingham Histological grade (Count of Participants) | |
Grade 1 |
2
12.5%
|
Grade 2 |
5
31.3%
|
Grade 3 |
9
56.3%
|
Initial tumor stage (Count of Participants) | |
Stage I |
6
37.5%
|
Stage II |
8
50%
|
Stage III |
2
12.5%
|
Prior surgery (Count of Participants) | |
Lumpectomy |
7
43.8%
|
Mastectomy |
9
56.3%
|
Prior radiation (Count of Participants) | |
Yes, received prior radiation |
15
93.8%
|
No |
1
6.3%
|
Outcome Measures
Title | Response Rate (Complete Response or Partial Response) |
---|---|
Description | Response rate (complete response or partial response) assessed using Response Evaluation Criteria in Solid Tumors version 1.1. |
Time Frame | Up to 36 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Treatment (Pembrolizumab, Enobosarm) |
---|---|
Arm/Group Description | Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Enobosarm: Given PO Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV |
Measure Participants | 16 |
Complete response |
1
6.3%
|
Partial response |
1
6.3%
|
Stable disease |
2
12.5%
|
Progressive disease |
12
75%
|
Title | Progression-free Survival |
---|---|
Description | Progression-free survival assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Kaplan-Meier estimates will be generated. |
Time Frame | Time to disease progression/relapse or death as a result of any cause, assessed up to 36 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Treatment (Pembrolizumab, Enobosarm) |
---|---|
Arm/Group Description | Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Enobosarm: Given PO Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV |
Measure Participants | 16 |
Median (95% Confidence Interval) [months] |
2.6
|
Title | Clinical Benefit Rate |
---|---|
Description | Clinical benefit rate assessed by immune-related Response Evaluation Criteria in Solid Tumors version 1.1. |
Time Frame | At 16 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Treatment (Pembrolizumab, Enobosarm) |
---|---|
Arm/Group Description | Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Enobosarm: Given PO Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV |
Measure Participants | 16 |
Count of Participants [Participants] |
4
25%
|
Title | Overall Survival |
---|---|
Description | Overall survival assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Kaplan-Meier estimates will be generated. |
Time Frame | Time to death as a result of any cause, assessed up to 36 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Treatment (Pembrolizumab, Enobosarm) |
---|---|
Arm/Group Description | Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Enobosarm: Given PO Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV |
Measure Participants | 16 |
Median (95% Confidence Interval) [months] |
25.5
|
Title | Progression-free Survival |
---|---|
Description | Progression-free survival defined as failure of treatment or death as a result of any cause assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Kaplan-Meier estimates will be generated. |
Time Frame | Up to 1 year |
Outcome Measure Data
Analysis Population Description |
---|
Two patients were not evaluable for response, and were excluded from progression-free survival. |
Arm/Group Title | Treatment (Pembrolizumab, Enobosarm) |
---|---|
Arm/Group Description | Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Enobosarm: Given PO Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV |
Measure Participants | 16 |
Median (95% Confidence Interval) [months] |
2.6
|
Adverse Events
Time Frame | 36 months from commencement of treatment | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | Treatment (Pembrolizumab, Enobosarm) | |
Arm/Group Description | Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Enobosarm: Given PO Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV | |
All Cause Mortality |
||
Treatment (Pembrolizumab, Enobosarm) | ||
Affected / at Risk (%) | # Events | |
Total | 8/18 (44.4%) | |
Serious Adverse Events |
||
Treatment (Pembrolizumab, Enobosarm) | ||
Affected / at Risk (%) | # Events | |
Total | 4/18 (22.2%) | |
Cardiac disorders | ||
10019279-Heart failure | 1/18 (5.6%) | 1 |
Metabolism and nutrition disorders | ||
10021038-Hyponatremia | 1/18 (5.6%) | 1 |
Musculoskeletal and connective tissue disorders | ||
10016750-Flank pain | 1/18 (5.6%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||
10001409-Adult respiratory distress syndrome | 1/18 (5.6%) | 1 |
10013963-Dyspnea | 1/18 (5.6%) | 1 |
Other (Not Including Serious) Adverse Events |
||
Treatment (Pembrolizumab, Enobosarm) | ||
Affected / at Risk (%) | # Events | |
Total | 18/18 (100%) | |
Blood and lymphatic system disorders | ||
10002272-Anemia | 5/18 (27.8%) | 5 |
Cardiac disorders | ||
10033557-Palpitations | 1/18 (5.6%) | 1 |
10040741-Sinus bradycardia | 1/18 (5.6%) | 1 |
10040752-Sinus tachycardia | 5/18 (27.8%) | 5 |
bradypnea | 1/18 (5.6%) | 1 |
Ear and labyrinth disorders | ||
10014020-Ear pain | 1/18 (5.6%) | 1 |
Endocrine disorders | ||
10001367-Adrenal insufficiency | 1/18 (5.6%) | 1 |
10020850-Hyperthyroidism | 1/18 (5.6%) | 1 |
10021114-Hypothyroidism | 1/18 (5.6%) | 1 |
Eye disorders | ||
10005886-Blurred vision | 1/18 (5.6%) | 1 |
eye discomfort | 1/18 (5.6%) | 1 |
Gastrointestinal disorders | ||
10000060-Abdominal distension | 1/18 (5.6%) | 1 |
10000081-Abdominal pain | 3/18 (16.7%) | 3 |
10005265-Bloating | 3/18 (16.7%) | 3 |
10010774-Constipation | 5/18 (27.8%) | 5 |
10012318-Dental caries | 1/18 (5.6%) | 1 |
10012727-Diarrhea | 8/18 (44.4%) | 8 |
10013781-Dry mouth | 1/18 (5.6%) | 1 |
10013946-Dyspepsia | 1/18 (5.6%) | 1 |
10013950-Dysphagia | 2/18 (11.1%) | 2 |
10015388-Esophageal pain | 1/18 (5.6%) | 1 |
10016766-Flatulence | 2/18 (11.1%) | 2 |
10017999-Gastrointestinal pain | 1/18 (5.6%) | 1 |
10028813-Nausea | 6/18 (33.3%) | 6 |
10047700-Vomiting | 6/18 (33.3%) | 6 |
discomfort | 1/18 (5.6%) | 1 |
General disorders | ||
10008531-Chills | 2/18 (11.1%) | 2 |
10011914-Death NOS | 4/18 (22.2%) | 4 |
10014222-Edema face | 1/18 (5.6%) | 1 |
10016059-Facial pain | 2/18 (11.1%) | 2 |
10016256-Fatigue | 13/18 (72.2%) | 13 |
10016558-Fever | 2/18 (11.1%) | 2 |
10017577-Gait disturbance | 1/18 (5.6%) | 1 |
10022095-Injection site reaction | 1/18 (5.6%) | 1 |
10033371-Pain | 3/18 (16.7%) | 3 |
10050068-Edema limbs | 4/18 (22.2%) | 4 |
10062466-Localized edema | 3/18 (16.7%) | 3 |
10062501-Non-cardiac chest pain | 4/18 (22.2%) | 4 |
DROWSINESS | 1/18 (5.6%) | 1 |
Immune system disorders | ||
10001718-Allergic reaction | 1/18 (5.6%) | 1 |
Infections and infestations | ||
10005047-Bladder infection | 1/18 (5.6%) | 1 |
10046300-Upper respiratory infection | 3/18 (16.7%) | 3 |
10046571-Urinary tract infection | 3/18 (16.7%) | 3 |
10048038-Wound infection | 1/18 (5.6%) | 1 |
stomach flu | 1/18 (5.6%) | 1 |
Injury, poisoning and procedural complications | ||
10016173-Fall | 2/18 (11.1%) | 2 |
10041569-Spinal fracture | 1/18 (5.6%) | 1 |
Investigations | ||
10001551-Alanine aminotransferase increased | 4/18 (22.2%) | 4 |
10003481-Aspartate aminotransferase increased | 4/18 (22.2%) | 4 |
10008661-Cholesterol high | 2/18 (11.1%) | 2 |
10011368-Creatinine increased | 1/18 (5.6%) | 1 |
10025256-Lymphocyte count decreased | 1/18 (5.6%) | 1 |
10029366-Neutrophil count decreased | 1/18 (5.6%) | 1 |
10035528-Platelet count decreased | 2/18 (11.1%) | 2 |
10047896-Weight gain | 2/18 (11.1%) | 2 |
10047900-Weight loss | 2/18 (11.1%) | 2 |
10049182-White blood cell decreased | 1/18 (5.6%) | 1 |
Metabolism and nutrition disorders | ||
10002646-Anorexia | 4/18 (22.2%) | 4 |
10020639-Hyperglycemia | 1/18 (5.6%) | 1 |
10020647-Hyperkalemia | 1/18 (5.6%) | 1 |
10020943-Hypoalbuminemia | 5/18 (27.8%) | 5 |
10020949-Hypocalcemia | 2/18 (11.1%) | 2 |
10021005-Hypoglycemia | 2/18 (11.1%) | 2 |
10021018-Hypokalemia | 3/18 (16.7%) | 3 |
10021028-Hypomagnesemia | 1/18 (5.6%) | 1 |
10021038-Hyponatremia | 5/18 (27.8%) | 5 |
10021059-Hypophosphatemia | 1/18 (5.6%) | 1 |
INCREASED TRIGLYCERIDES | 1/18 (5.6%) | 1 |
Musculoskeletal and connective tissue disorders | ||
10003239-Arthralgia | 3/18 (16.7%) | 3 |
10003988-Back pain | 6/18 (33.3%) | 6 |
10006002-Bone pain | 2/18 (11.1%) | 2 |
10008496-Chest wall pain | 1/18 (5.6%) | 1 |
10016750-Flank pain | 1/18 (5.6%) | 1 |
10028411-Myalgia | 4/18 (22.2%) | 4 |
10028836-Neck pain | 4/18 (22.2%) | 4 |
10033425-Pain in extremity | 2/18 (11.1%) | 2 |
10062572-Generalized muscle weakness | 2/18 (11.1%) | 2 |
GENERALIZED MSK PAIN | 1/18 (5.6%) | 1 |
LEFT SHOULDER PAIN | 1/18 (5.6%) | 1 |
RIGHT HIP PAIN | 1/18 (5.6%) | 1 |
RIGHT KNEE PAIN | 1/18 (5.6%) | 1 |
RIGHT THIGH PAIN | 1/18 (5.6%) | 1 |
increased muscle mass | 1/18 (5.6%) | 1 |
muscle spasm | 1/18 (5.6%) | 1 |
muscle spasms (back) | 1/18 (5.6%) | 1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
actinic keratosis, hyperplastic | 1/18 (5.6%) | 1 |
progressive disease | 6/18 (33.3%) | 6 |
Nervous system disorders | ||
10013573-Dizziness | 4/18 (22.2%) | 4 |
10013911-Dysgeusia | 1/18 (5.6%) | 1 |
10019211-Headache | 9/18 (50%) | 9 |
10020765-Hypersomnia | 1/18 (5.6%) | 1 |
10024264-Lethargy | 1/18 (5.6%) | 1 |
10034620-Peripheral sensory neuropathy | 2/18 (11.1%) | 2 |
10041349-Somnolence | 1/18 (5.6%) | 1 |
10044565-Tremor | 2/18 (11.1%) | 2 |
Psychiatric disorders | ||
10002855-Anxiety | 4/18 (22.2%) | 4 |
10012378-Depression | 2/18 (11.1%) | 2 |
10022437-Insomnia | 5/18 (27.8%) | 5 |
10024419-Libido decreased | 1/18 (5.6%) | 1 |
Renal and urinary disorders | ||
10019450-Hematuria | 2/18 (11.1%) | 2 |
10037032-Proteinuria | 4/18 (22.2%) | 4 |
10046539-Urinary frequency | 1/18 (5.6%) | 1 |
10046593-Urinary urgency | 1/18 (5.6%) | 1 |
10061574-Urinary tract obstruction | 1/18 (5.6%) | 1 |
10063057-Cystitis noninfective | 1/18 (5.6%) | 1 |
oliguria (mild) | 1/18 (5.6%) | 1 |
Reproductive system and breast disorders | ||
10006298-Breast pain | 1/18 (5.6%) | 1 |
10046904-Vaginal dryness | 1/18 (5.6%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||
10003504-Aspiration | 1/18 (5.6%) | 1 |
10011224-Cough | 5/18 (27.8%) | 5 |
10013963-Dyspnea | 7/18 (38.9%) | 7 |
10015090-Epistaxis | 1/18 (5.6%) | 1 |
10021143-Hypoxia | 2/18 (11.1%) | 2 |
10028735-Nasal congestion | 1/18 (5.6%) | 1 |
10035598-Pleural effusion | 2/18 (11.1%) | 2 |
10036402-Postnasal drip | 1/18 (5.6%) | 1 |
10036790-Productive cough | 2/18 (11.1%) | 2 |
10041367-Sore throat | 3/18 (16.7%) | 3 |
10047924-Wheezing | 3/18 (16.7%) | 3 |
OBSTRUCTIVE PNEUMONIA | 1/18 (5.6%) | 1 |
bilateral pneumonia | 1/18 (5.6%) | 1 |
hemoptysis | 2/18 (11.1%) | 2 |
rhonchi breath sounds | 1/18 (5.6%) | 1 |
Skin and subcutaneous tissue disorders | ||
10001760-Alopecia | 1/18 (5.6%) | 1 |
10013786-Dry skin | 1/18 (5.6%) | 1 |
10020642-Hyperhidrosis | 3/18 (16.7%) | 3 |
10033474-Pain of skin | 1/18 (5.6%) | 1 |
10037087-Pruritus | 4/18 (22.2%) | 4 |
10037847-Rash acneiform | 3/18 (16.7%) | 3 |
10037868-Rash maculo-papular | 2/18 (11.1%) | 2 |
10054541-Periorbital edema | 1/18 (5.6%) | 1 |
Surgical and medical procedures | ||
stent placement | 1/18 (5.6%) | 1 |
Vascular disorders | ||
10016825-Flushing | 1/18 (5.6%) | 1 |
10020407-Hot flashes | 2/18 (11.1%) | 2 |
10020772-Hypertension | 12/18 (66.7%) | 12 |
10021097-Hypotension | 5/18 (27.8%) | 5 |
10025233-Lymphedema | 2/18 (11.1%) | 2 |
10042554-Superficial thrombophlebitis | 1/18 (5.6%) | 1 |
10043565-Thromboembolic event | 2/18 (11.1%) | 2 |
Limitations/Caveats
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.
Results Point of Contact
Name/Title | Yuan Yuan, MD, PhD. |
---|---|
Organization | Department of Medical Oncology, City of Hope |
Phone | 626-256-4673 ext 89200 |
yuyuan@coh.org |
- 16131
- NCI-2016-01759
- 16131