Bevacizumab Given With Either Anastrozole or Fulvestrant With Trastuzumab for Postmenopausal Metastatic Breast Cancer
Study Details
Study Description
Brief Summary
This is a phase II trial combining bevacizumab with either fulvestrant or anastrozole with trastuzumab in the treatment of metastatic breast cancer in postmenopausal women. It is hoped that these combinations will keep the cancer from growing and spreading further.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
Regimen A: Bevacizumab/anastrozole (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles. Response assessments will be performed after 2 cycles. Patients who respond to treatment or have stable disease will continue to be evaluated every 2 cycles. After 6 months, response assessment will occur every 3 months. A patient may remain on study if radiation is deemed necessary and appropriate, provided that there are other sites of measurable disease outside the field of radiation that may be followed. Treatment occurs until disease progression. Patients will be selected for this treatment arm per the following guidelines: >=12 months from adjuvant endocrine therapy OR >=12 months from adjuvant aromatase inhibitors OR Endocrine therapy naive OR Prior tamoxifen exposure or tamoxifen intolerance
Regimen B: Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscularly of fulvestrant). Treatment will be given in 4-week cycles. Response assessments will be performed after 2 cycles. Patients who respond to treatment or have stable disease will continue to be evaluated every 2 cycles. After 6 months, response assessment will occur every 3 months. A patient may remain on study if radiation is deemed necessary and appropriate, provided that there are other sites of measurable disease outside the field of radiation that may be followed. Treatment occurs until disease progression. Patients will be selected for this treatment arm per the following guidelines: <12 months from adjuvant aromatase inhibitor therapy OR Intolerant of aromatase inhibitors OR Disease progression on adjuvant aromatase inhibitors OR Physician discretion
Trastuzumab: Patients in Treatment Arm A or Treatment Arm B who have FISH HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to their treatment with the combination of bevacizumab with either anastrozole or fulvestrant. Trastuzumab will be administered ONLY to patients with HER2+ breast cancer (FISH-positive or IHC3+). An 8 mg/kg loading dose of IV trastuzumab will be administered on Day 1, followed by doses of 6 mg/kg IV trastuzumab once every 3 weeks. These patients will have the option of receiving their bevacizumab doses at 15 mg/kg every 3 weeks rather than 10 mg/kg every 2 weeks (if they prefer to keep their bevacizumab dosing schedule consistent with their trastuzumab dosing schedule so that the number of visits they must make to the study site is minimized). The dosing schedules for anastrozole (for HER2+ patients in Treatment Arm A) and fulvestrant (for HER2+ patients in Treatment Arm B) will not change.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bevacizumab/anastrozole Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles. |
Drug: Bevacizumab
Bevacizumab 10mg/kg IV every 2 weeks
Other Names:
Drug: Anastrozole
anastrozole (1 mg orally daily)
Other Names:
|
| Experimental: Bevacizumab/fulvestrant Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg IM on Day 1 of Cycle 1, followed by 250 mg IM of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg IM of fulvestrant). Treatment will be given in 4-week cycles. |
Drug: Bevacizumab
Bevacizumab 10mg/kg IV every 2 weeks
Other Names:
Drug: Fulvestrant
fulvestrant (500 mg IM on Day 1 of Cycle 1, followed by 250 mg IM of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg IM of fulvestrant).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease [18 months]
Progression Free Survival (PFS) is defined as the interval, in months, from the date of first treatment to the date of disease progression or death, whichever occurred first.
Secondary Outcome Measures
- Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [18 months]
The Percentage of Patients Who Experience an Objective Benefit From Treatment (CR+PR). The response categories were assigned using RECIST criteria. Complete Response (CR) = Disappearance of all target lesions ; Partial Response (PR) = >=30% decrease in the sum of the longest diameter of target lesions.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Postmenopausal breast cancer (adenocarcinoma) estrogen (ER)and/or progesterone (PR) receptor positive that is locally advanced or locally recurrent and not able to be surgically removed OR with measurable and/or disease that is able to be assessed including isolated bone metastasis
-
Female patients 18 years or older
-
Documentation of ER+ and/or PR+
-
No prior chemotherapy or hormone therapy for metastatic breast cancer or inoperable breast cancer that is locally recurrent or locally advanced
-
Measurable or evaluable disease
-
Radiation therapy to painful bone lesions or impending fractures is allowed as long as there is measurable or evaluable disease outside the radiated area.
-
Must have adequate bone marrow, renal and liver function
-
Patients receiving prior treatment with an anthracycline based chemotherapy must have a normal left ventricle ejection fraction
Exclusion Criteria:
-
No metastatic disease to the Central Nervous System
-
No history of myocardial infarction (MI), stroke or transient ischemic attacks in the last 6 months
-
No symptoms of peripheral vascular disease
-
No history of abdominal fistula, gastrointestinal perforation or intrabdominal abscess in the past 6 months
-
No known hypersensitivity to phosphate, trehalose or polysorbate
-
No serious non-healing wound, ulcer or bone fracture
-
No uncontrolled high blood pressure or history of hypertensive crisis
-
No New York Hear Association class II congestive heart failure
-
No extensive cancer involvement of the liver or lungs
-
No history of significant psychiatric disorders
-
No significant vascular disease
There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Florida Cancer Specialists | Fort Myers | Florida | United States | 33901 |
| 2 | Integrated Community Oncology Network | Jacksonville | Florida | United States | 32256 |
| 3 | Florida Hospital Cancer Institute | Orlando | Florida | United States | 32804 |
| 4 | Northeast Georgia Medical Center | Gainesville | Georgia | United States | 30501 |
| 5 | Wellstar Cancer Research | Marietta | Georgia | United States | 30060 |
| 6 | Graves-Gilbert Clinic | Bowling Green | Kentucky | United States | 42101 |
| 7 | Baton Rouge General Medical Center | Baton Rouge | Louisiana | United States | 70806 |
| 8 | St. Louis Cancer Care | Chesterfield | Missouri | United States | 63017 |
| 9 | Sletten Cancer Institute | Great Falls | Montana | United States | 59405 |
| 10 | Chattanooga Oncology & Hematology Associates | Chattanooga | Tennessee | United States | 37404 |
| 11 | Tennessee Oncology, PLLC | Nashville | Tennessee | United States | 37203 |
Sponsors and Collaborators
- SCRI Development Innovations, LLC
- Genentech, Inc.
- AstraZeneca
Investigators
- Principal Investigator: Denise A Yardley, MD, SCRI Development Innovations, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
- SCRI BRE 86
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Bevacizumab/Anastrozole | Bevacizumab/Fulvestrant |
|---|---|---|
| Arm/Group Description | Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles. | Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles. |
| Period Title: Overall Study | ||
| STARTED | 38 | 41 |
| COMPLETED | 38 | 41 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Bevacizumab/Anastrozole | Bevacizumab/Fulvestrant | Total |
|---|---|---|---|
| Arm/Group Description | Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles. | Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles. | Total of all reporting groups |
| Overall Participants | 38 | 41 | 79 |
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
62
|
63
|
63
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
38
100%
|
41
100%
|
79
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
38
100%
|
41
100%
|
79
100%
|
Outcome Measures
| Title | Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease |
|---|---|
| Description | Progression Free Survival (PFS) is defined as the interval, in months, from the date of first treatment to the date of disease progression or death, whichever occurred first. |
| Time Frame | 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Bevacizumab/Anastrozole | Bevacizumab/Fulvestrant |
|---|---|---|
| Arm/Group Description | Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles. | Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles. |
| Measure Participants | 38 | 41 |
| Median (95% Confidence Interval) [months] |
21
|
9
|
| Title | Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment |
|---|---|
| Description | The Percentage of Patients Who Experience an Objective Benefit From Treatment (CR+PR). The response categories were assigned using RECIST criteria. Complete Response (CR) = Disappearance of all target lesions ; Partial Response (PR) = >=30% decrease in the sum of the longest diameter of target lesions. |
| Time Frame | 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Bevacizumab/Anastrozole | Bevacizumab/Fulvestrant |
|---|---|---|
| Arm/Group Description | Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles. | Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles. |
| Measure Participants | 38 | 41 |
| Count of Participants [Participants] |
18
47.4%
|
11
26.8%
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Bevacizumab/Anastrozole | Bevacizumab/Fulvestrant | ||
| Arm/Group Description | Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles. | Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles. | ||
All Cause Mortality |
||||
| Bevacizumab/Anastrozole | Bevacizumab/Fulvestrant | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Bevacizumab/Anastrozole | Bevacizumab/Fulvestrant | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/38 (26.3%) | 12/41 (29.3%) | ||
| Cardiac disorders | ||||
| cTnI | 0/38 (0%) | 0 | 1/41 (2.4%) | 1 |
| Superventricular Arrhythmia - Sinus Bradycardia | 1/38 (2.6%) | 1 | 0/41 (0%) | 0 |
| Pain - Cardiac | 0/38 (0%) | 0 | 1/41 (2.4%) | 1 |
| Cardiac Ischemia/Infarction | 0/38 (0%) | 0 | 1/41 (2.4%) | 1 |
| Restrictive Cardiomyopathy | 1/38 (2.6%) | 1 | 0/41 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Dehydration | 0/38 (0%) | 0 | 1/41 (2.4%) | 1 |
| Diarrhea | 1/38 (2.6%) | 1 | 0/41 (0%) | 0 |
| Vomiting | 1/38 (2.6%) | 1 | 0/41 (0%) | 0 |
| Nausea | 1/38 (2.6%) | 1 | 0/41 (0%) | 0 |
| General disorders | ||||
| Death | 0/38 (0%) | 0 | 1/41 (2.4%) | 1 |
| Weakness | 1/38 (2.6%) | 1 | 0/41 (0%) | 0 |
| Infections and infestations | ||||
| Infection - Pneumonia | 0/38 (0%) | 0 | 1/41 (2.4%) | 1 |
| Infection - Wound | 0/38 (0%) | 0 | 1/41 (2.4%) | 1 |
| Metabolism and nutrition disorders | ||||
| Failure to Thrive | 0/38 (0%) | 0 | 1/41 (2.4%) | 1 |
| Hypernatremia | 1/38 (2.6%) | 1 | 0/41 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Fracture | 0/38 (0%) | 0 | 1/41 (2.4%) | 1 |
| Nervous system disorders | ||||
| Syncope | 0/38 (0%) | 0 | 1/41 (2.4%) | 2 |
| Seizure | 0/38 (0%) | 0 | 1/41 (2.4%) | 1 |
| CNS Ischemia | 1/38 (2.6%) | 1 | 1/41 (2.4%) | 1 |
| Psychiatric disorders | ||||
| Mood Alteration - Depression | 0/38 (0%) | 0 | 1/41 (2.4%) | 1 |
| Renal and urinary disorders | ||||
| Renal Failure | 0/38 (0%) | 0 | 1/41 (2.4%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnea | 3/38 (7.9%) | 3 | 0/41 (0%) | 0 |
| ARDS | 1/38 (2.6%) | 1 | 0/41 (0%) | 0 |
| Surgical and medical procedures | ||||
| Pain - Abdomen | 1/38 (2.6%) | 1 | 0/41 (0%) | 0 |
| Vascular disorders | ||||
| Thrombosis/Thrombus/Embolism | 1/38 (2.6%) | 1 | 0/41 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Bevacizumab/Anastrozole | Bevacizumab/Fulvestrant | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 38/38 (100%) | 41/41 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Edema - Limb | 5/38 (13.2%) | 46 | 7/41 (17.1%) | 33 |
| Edema - NOS | 3/38 (7.9%) | 23 | 0/41 (0%) | 0 |
| Hemoglobin | 13/38 (34.2%) | 57 | 12/41 (29.3%) | 44 |
| Hemorrhage - Nose | 8/38 (21.1%) | 14 | 10/41 (24.4%) | 21 |
| Leukopenia | 5/38 (13.2%) | 13 | 8/41 (19.5%) | 19 |
| Lymphedema | 2/38 (5.3%) | 7 | 0/41 (0%) | 0 |
| Neutrophils | 2/38 (5.3%) | 46 | 3/41 (7.3%) | 4 |
| Platelets | 8/38 (21.1%) | 41 | 4/41 (9.8%) | 11 |
| Cardiac disorders | ||||
| Cardiac Genral, Other (Decreased LVEF) | 2/38 (5.3%) | 2 | 0/41 (0%) | 0 |
| Hypertension | 18/38 (47.4%) | 70 | 20/41 (48.8%) | 110 |
| Hypotension | 0/38 (0%) | 0 | 5/41 (12.2%) | 6 |
| Endocrine disorders | ||||
| Hot Flashes | 13/38 (34.2%) | 51 | 8/41 (19.5%) | 23 |
| Gastrointestinal disorders | ||||
| Anorexia | 7/38 (18.4%) | 23 | 7/41 (17.1%) | 27 |
| Constipation | 5/38 (13.2%) | 11 | 7/41 (17.1%) | 8 |
| Dehydration | 2/38 (5.3%) | 2 | 5/41 (12.2%) | 6 |
| Diarrhea | 9/38 (23.7%) | 18 | 9/41 (22%) | 12 |
| Heartburn | 4/38 (10.5%) | 17 | 7/41 (17.1%) | 27 |
| Hemorrhoids | 2/38 (5.3%) | 10 | 0/41 (0%) | 0 |
| Mucositis/Stomatitis | 4/38 (10.5%) | 4 | 7/41 (17.1%) | 20 |
| Nausea | 14/38 (36.8%) | 48 | 12/41 (29.3%) | 44 |
| Taste Alteration | 3/38 (7.9%) | 20 | 0/41 (0%) | 0 |
| Vomiting | 7/38 (18.4%) | 14 | 5/41 (12.2%) | 7 |
| General disorders | ||||
| Fatigue | 22/38 (57.9%) | 168 | 30/41 (73.2%) | 170 |
| Fever | 4/38 (10.5%) | 4 | 3/41 (7.3%) | 5 |
| Pain - Head | 17/38 (44.7%) | 53 | 3/41 (7.3%) | 3 |
| Insomnia | 5/38 (13.2%) | 13 | 4/41 (9.8%) | 10 |
| Pain - Abdomen | 4/38 (10.5%) | 22 | 0/41 (0%) | 0 |
| Pain - Back | 8/38 (21.1%) | 39 | 12/41 (29.3%) | 24 |
| Pain - Bladder | 2/38 (5.3%) | 2 | 0/41 (0%) | 0 |
| Pain - Bone | 4/38 (10.5%) | 9 | 7/41 (17.1%) | 61 |
| Pain - Breast | 2/38 (5.3%) | 2 | 0/41 (0%) | 0 |
| Pain - Chest Wall | 6/38 (15.8%) | 6 | 5/41 (12.2%) | 12 |
| Pain - Ear | 2/38 (5.3%) | 6 | 0/41 (0%) | 0 |
| Pain - Joint | 11/38 (28.9%) | 37 | 10/41 (24.4%) | 28 |
| Pain - Limb | 13/38 (34.2%) | 81 | 12/41 (29.3%) | 32 |
| Pain - Muscle | 4/38 (10.5%) | 10 | 3/41 (7.3%) | 9 |
| Pain - Neck | 3/38 (7.9%) | 24 | 0/41 (0%) | 0 |
| Pain - NOS | 2/38 (5.3%) | 9 | 0/41 (0%) | 0 |
| Pain - Pelvis | 0/38 (0%) | 0 | 3/41 (7.3%) | 10 |
| Rigor/Chills | 2/38 (5.3%) | 2 | 3/41 (7.3%) | 8 |
| Sweating | 0/38 (0%) | 0 | 4/41 (9.8%) | 11 |
| Weakness | 5/38 (13.2%) | 11 | 0/41 (0%) | 0 |
| Infections and infestations | ||||
| Infection - Dental | 0/38 (0%) | 0 | 3/41 (7.3%) | 6 |
| Infection - Ear | 2/38 (5.3%) | 6 | 0/41 (0%) | 0 |
| Infection - Sinus | 4/38 (10.5%) | 16 | 4/41 (9.8%) | 5 |
| Infection - Skin | 2/38 (5.3%) | 2 | 0/41 (0%) | 0 |
| Infection - Bladder | 6/38 (15.8%) | 9 | 3/41 (7.3%) | 6 |
| Infection - Pulmonary | 4/38 (10.5%) | 5 | 0/41 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| AST | 2/38 (5.3%) | 4 | 0/41 (0%) | 0 |
| Bilirubin | 2/38 (5.3%) | 3 | 0/41 (0%) | 0 |
| Creatinine | 0/38 (0%) | 0 | 3/41 (7.3%) | 20 |
| Hypercalcemia | 3/38 (7.9%) | 8 | 3/41 (7.3%) | 5 |
| Hyperglycemia | 3/38 (7.9%) | 7 | 3/41 (7.3%) | 7 |
| Hypocalcemia | 2/38 (5.3%) | 2 | 0/41 (0%) | 0 |
| Hypokalemia | 0/38 (0%) | 0 | 3/41 (7.3%) | 3 |
| Proteinuria | 13/38 (34.2%) | 97 | 18/41 (43.9%) | 91 |
| Weight Loss | 4/38 (10.5%) | 32 | 3/41 (7.3%) | 4 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 13/38 (34.2%) | 121 | 10/41 (24.4%) | 34 |
| Myalgia | 4/38 (10.5%) | 9 | 5/41 (12.2%) | 14 |
| Nervous system disorders | ||||
| Confusion | 2/38 (5.3%) | 2 | 0/41 (0%) | 0 |
| Dizziness | 4/38 (10.5%) | 9 | 9/41 (22%) | 22 |
| Neuropathy - Motor | 2/38 (5.3%) | 5 | 0/41 (0%) | 0 |
| Neuropathy - Sensory | 7/38 (18.4%) | 12 | 9/41 (22%) | 15 |
| Psychiatric disorders | ||||
| Mood Alteration - Anxiety | 5/38 (13.2%) | 18 | 6/41 (14.6%) | 18 |
| Mood Alteration - Depression | 4/38 (10.5%) | 19 | 4/41 (9.8%) | 26 |
| Mood Alteration - NOS | 3/38 (7.9%) | 11 | 0/41 (0%) | 0 |
| Renal and urinary disorders | ||||
| Renal Insufficiency | 2/38 (5.3%) | 2 | 0/41 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 7/38 (18.4%) | 10 | 8/41 (19.5%) | 29 |
| Dyspnea | 6/38 (15.8%) | 9 | 9/41 (22%) | 13 |
| Pleural Effusion | 2/38 (5.3%) | 2 | 0/41 (0%) | 0 |
| Rhinitis | 9/38 (23.7%) | 32 | 7/41 (17.1%) | 38 |
| Voice Changes | 0/38 (0%) | 0 | 5/41 (12.2%) | 28 |
| Skin and subcutaneous tissue disorders | ||||
| Bruising | 0/38 (0%) | 0 | 3/41 (7.3%) | 3 |
| Injection Site Reaction | 0/38 (0%) | 0 | 3/41 (7.3%) | 3 |
| Pruritis | 3/38 (7.9%) | 3 | 0/41 (0%) | 0 |
| Rash/Desquamation | 4/38 (10.5%) | 14 | 5/41 (12.2%) | 6 |
| Surgical and medical procedures | ||||
| Wound Complication | 2/38 (5.3%) | 2 | 0/41 (0%) | 0 |
| Vascular disorders | ||||
| Thrombosis/Thrombus/Embolism | 2/38 (5.3%) | 13 | 0/41 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
Results Point of Contact
| Name/Title | John Hainsworth, MD |
|---|---|
| Organization | Sarah Cannon Research Institute |
| Phone | 1-877-691-7274 |
| asksarah@scresearch.net |
- SCRI BRE 86