Ixabepilone and Carboplatin +/- Bevacizumab in Advanced Non-Small-Cell Lung Cancer
Study Details
Study Description
Brief Summary
This is a multicenter, non-randomized, Phase II study of patients with previously untreated NSCLC not amenable to radiotherapy or surgical treatment. The planned enrollment for this trial is 78 patients (including a 10% rate for inevaluable patients). There will be a total of 39 patients in each cohort (Cohorts A and B).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed Description
The trial will include a lead-in phase for each cohort to assess safety. In Cohort A, 10 patients will receive ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle. If no unexpected toxicities occur, Cohort A will open to enrollment. Enrollment for Cohort A will be done in two stages (after the lead-in portion is completed). The first stage for Cohort A will enroll a total of 22 patients (this will include the 10 patients from the lead-in phase). If there are at least 3 responses during stage 1, enrollment for stage 2 will proceed. For stage 2 of the study, 17 additional patients will be enrolled (for a total of 39 patients in Cohort A). During stage 1 and stage 2, patients in Cohort A will receive treatment with ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of each 21-day treatment cycle. Treatment will continue until disease progression or unacceptable toxicity occurs.
After the lead-in phase for Cohort A is completed, a similar lead-in portion, also consisting of 10 patients, will be done for Cohort B. Patients in Cohort B will receive ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle. If no unexpected toxicities occur in this group, Cohort B will open to enrollment. Enrollment for Cohort B will also be done in two stages (after the lead-in portion is completed). The first stage for Cohort B will enroll a total of 22 patients (this will include the 10 patients from the lead-in phase). If there are at least 3 responses during stage 1, enrollment for stage 2 will proceed. For stage 2 of the study, 17 additional patients will be enrolled (for a total of 39 patients in Cohort B). During stage 1 and stage 2, patients in Cohort B will receive treatment with ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of each 21-day treatment cycle. Treatment will continue until disease progression or unacceptable toxicity occurs.
Unexpected toxicities include any grade 4 hematologic toxicity or grade 3/4 non hematologic toxicity that does not reverse within 7 days in more than 2 patients.
Eligible patients will receive ixabepilone, carboplatin, and bevacizumab (bevacizumab will be administered to patients in Cohort B only) at 21-day intervals. Patients will be re evaluated every 6 weeks using computerized tomography (CT) scans. Response to therapy will be assigned using Response Evaluation Criteria in Solid Tumors (RECIST) (Therasse et al. 2000) (see Section 7). Patients who have objective response or stable disease will continue treatment for 6 cycles, until the time of tumor progression or intolerable treatment-related side effects. Patients in Cohort B without progressive disease will be eligible to receive bevacizumab monotherapy for 6 additional cycles, or until undue toxicity or tumor progression occurs.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cohort A ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle. |
Drug: Ixabepilone
ixabepilone 30 mg/m2
Other Names:
Drug: Carboplatin
carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
Other Names:
|
Experimental: Cohort B ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle. |
Drug: Ixabepilone
ixabepilone 30 mg/m2
Other Names:
Drug: Carboplatin
carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
Other Names:
Drug: Bevacizumab
bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall 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
Secondary Outcome Measures
- Progression Free Survival, the Length of Time, That Patients Were Alive From Their First Date of Treatment Until Worsening of Their Disease [18 months]
- Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death [18 months]
- Number of Participants Experiencing Treatment Related Toxicity [18 months]
Number of participants experiencing Grade 3 and Grade 4 Treatment-related toxicities are reported here. Toxicities that were occurring >=5% of total patients are listed. Toxicity was assessed using the Common Terminology Criteria for Adverse Events (CTCAE version 3.0) of the National Cancer Institute.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically confirmed non-small-cell bronchogenic carcinoma (squamous carcinoma, adenocarcinoma, or large cell carcinoma). Cytologic specimens obtained by brushings, washings, or needle aspiration of the defined lesion are acceptable. Mixed tumors with small-cell anaplastic elements are not eligible.
-
Patients who have newly diagnosed unresectable stage III or IV disease are eligible. Patients with stage III disease should be ineligible for combined modality therapy
-
Patients must not have received any prior antineoplastic chemotherapy for metastatic lung cancer prior to study entry.
-
Patients who have had previous radiotherapy as definitive therapy for locally advanced non-small-cell are eligible as long as the recurrence is outside the original radiation port. Radiation therapy must have been completed greater than 4 weeks prior to registration.
-
Male or female patients >=18 years of age.
-
Life expectancy of at least 3 months.
-
ECOG performance status of <=1.
-
Measurable disease by RECIST criteria (see Section 7).
-
Laboratory values as follows:
-
ANC >=1500/mm3 (7 days prior to treatment);
-
Hemoglobin >=8 g/dL;
-
Platelets >=100,000 mm3 (7 days prior to treatment)
-
Bilirubin <=1 x ULN for institution
-
AST/SGOT <=2.5 x ULN or <=5.0 x ULN in patients with liver metastases and
-
ALT/SGPT <=2.5 x ULN or <=5.0 x ULN in patients with liver metastases
-
Creatinine <=2.0 mg/dL or
-
Calculated (measured) GFR >=40 mL/min
-
PT/INR and PTT <=1.5 x ULN
- Peripheral neuropathy <= grade 1.
Exclusion Criteria:
-
A history of cardiac disease as defined by malignant hypertension, unstable angina, congestive heart failure of > grade 2 per New York Heart Association (NYHA) criteria (see Appendix B), myocardial infarction within the previous 6 months, or symptomatic cardiac arrhythmias.
-
Metastatic brain or meningeal tumors.
-
Uncontrolled intercurrent illness.
-
Chemotherapy, investigational drug therapy, or major surgery ≤ 4 weeks prior to starting study drug, or patients who have not recovered from side effects of previous therapy.
-
Patient is <=5 years free of another primary malignancy, except if the other primary malignancy is not currently clinically significant or requiring active intervention, or if the other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ.
Exclusion Criteria for Enrollment on Bevacizumab (Cohort B):
-
Patients with squamous cell histology NSCLC.
-
Patients who have had a major surgical procedure (not including mediastinoscopy), open biopsy, or significant traumatic injury within 1 month of beginning bevacizumab.
-
Patients who have had primary thoracic radiation within 3 months of beginning bevacizumab.
-
Fine needle aspiration, core biopsy, mediastinoscopy or other minor surgical procedure within 7 days of beginning bevacizumab.
-
Patients receiving thrombolytic therapy within 10 days of starting bevacizumab.
-
Patients with serious non-healing wound, ulcer, or bone fracture.
-
Patients with evidence of bleeding diathesis or coagulopathy.
-
Patients with history of hemoptysis (defined as bright red blood of ½ teaspoon or more per episode) within 3 months prior to study enrollment.
-
Patients with proteinuria at screening, as demonstrated by either:
-
Urine protein : creatinine (UPC) ratio >=1.0 or
-
Urine dipstick for protein >=2+ (patients discovered to have >=2+ proteinuria on dipstick at baseline should undergo a 24-hour urine collection, and must demonstrate <1 g of protein in 24 hours to be eligible).
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning bevacizumab.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Florida Cancer Specialists | Fort Myers | Florida | United States | 33901 |
2 | Gainsville Hematology Oncology Associates | Gainesville | Florida | United States | 32605 |
3 | Providence Medical Group | Terre Haute | Indiana | United States | 47802 |
4 | Consultants in Blood Disorders and Cancer | Louisville | Kentucky | United States | 40207 |
5 | Center for Cancer and Blood Disorders | Bethesda | Maryland | United States | 20817 |
6 | Grand Rapids Clinical Oncology Program | Grand Rapids | Michigan | United States | 49503 |
7 | Research Medical Center | Kansas City | Missouri | United States | 64132 |
8 | Dr. Donald Berdeaux | Great Falls | Montana | United States | 59405 |
9 | Oncology Hematology Care | Cincinnati | Ohio | United States | 45242 |
10 | South Carolina Oncology Associates | Columbia | South Carolina | United States | 29210 |
11 | Spartanburg Regional Medical Center | Spartanburg | South Carolina | United States | 29303 |
12 | Tennessee Oncology, PLLC | Nashville | Tennessee | United States | 37023 |
13 | Peninsula Cancer Institute | Newport News | Virginia | United States | 23601 |
Sponsors and Collaborators
- SCRI Development Innovations, LLC
- Bristol-Myers Squibb
- Genentech, Inc.
Investigators
- Study Chair: David R Spigel, MD, Sarah Cannon Research Insititute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SCRI LUN 179
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Ixabepilone/Carboplatin | Ixabepilone/Carboplatin/Bevacizumab |
---|---|---|
Arm/Group Description | ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle. | ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle. |
Period Title: Overall Study | ||
STARTED | 42 | 40 |
COMPLETED | 38 | 36 |
NOT COMPLETED | 4 | 4 |
Baseline Characteristics
Arm/Group Title | Ixabepilone/Carboplatin | Ixabepilone/Carboplatin/Bevacizumab | Total |
---|---|---|---|
Arm/Group Description | ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle. | ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle. | Total of all reporting groups |
Overall Participants | 42 | 40 | 82 |
Age (years) [Median (Full Range) ] | |||
Median (Full Range) [years] |
63
|
63
|
63
|
Sex: Female, Male (Count of Participants) | |||
Female |
18
42.9%
|
21
52.5%
|
39
47.6%
|
Male |
24
57.1%
|
19
47.5%
|
43
52.4%
|
Region of Enrollment (participants) [Number] | |||
United States |
42
100%
|
40
100%
|
82
100%
|
Outcome Measures
Title | Overall 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 |
Time Frame | 18 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Ixabepilone/Carboplatin | Ixabepilone/Carboplatin/Bevacizumab |
---|---|---|
Arm/Group Description | ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle. | ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle. |
Measure Participants | 38 | 36 |
Number (95% Confidence Interval) [percentage of participants] |
29
69%
|
50
125%
|
Title | Progression Free Survival, the Length of Time, That Patients Were Alive From Their First Date of Treatment Until Worsening of Their Disease |
---|---|
Description | |
Time Frame | 18 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Ixabepilone/Carboplatin | Ixabepilone/Carboplatin/Bevacizumab |
---|---|---|
Arm/Group Description | ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle. | ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle. |
Measure Participants | 42 | 40 |
Median (95% Confidence Interval) [months] |
5.3
|
6.7
|
Title | Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death |
---|---|
Description | |
Time Frame | 18 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Ixabepilone/Carboplatin | Ixabepilone/Carboplatin/Bevacizumab |
---|---|---|
Arm/Group Description | ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle. | ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle. |
Measure Participants | 42 | 40 |
Median (95% Confidence Interval) [months] |
9.3
|
13.2
|
Title | Number of Participants Experiencing Treatment Related Toxicity |
---|---|
Description | Number of participants experiencing Grade 3 and Grade 4 Treatment-related toxicities are reported here. Toxicities that were occurring >=5% of total patients are listed. Toxicity was assessed using the Common Terminology Criteria for Adverse Events (CTCAE version 3.0) of the National Cancer Institute. |
Time Frame | 18 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Ixabepilone/Carboplatin | Ixabepilone/Carboplatin/Bevacizumab |
---|---|---|
Arm/Group Description | ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle. | ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle. |
Measure Participants | 42 | 40 |
Anemia |
4
9.5%
|
6
15%
|
Leukopenia |
6
14.3%
|
9
22.5%
|
Neutropenia |
13
31%
|
19
47.5%
|
Febrile neutropenia |
1
2.4%
|
1
2.5%
|
Cardiac arrhythmia |
2
4.8%
|
0
0%
|
Dehydration |
3
7.1%
|
3
7.5%
|
Diarrhea |
3
7.1%
|
3
7.5%
|
Fatique |
4
9.5%
|
9
22.5%
|
Hyponatremia |
2
4.8%
|
1
2.5%
|
Infection |
2
4.8%
|
8
20%
|
Pain (all types) |
4
9.5%
|
11
27.5%
|
Dyspnea |
4
9.5%
|
4
10%
|
Thrombocytopenia |
8
19%
|
8
20%
|
Vomiting |
0
0%
|
4
10%
|
Hemorrhagic events (all) |
0
0%
|
1
2.5%
|
allergic (HSR) |
0
0%
|
2
5%
|
Cough |
0
0%
|
4
10%
|
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Ixabepilone/Carboplatin | Ixabepilone/Carboplatin/Bevacizumab | ||
Arm/Group Description | ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle. | ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle. | ||
All Cause Mortality |
||||
Ixabepilone/Carboplatin | Ixabepilone/Carboplatin/Bevacizumab | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Ixabepilone/Carboplatin | Ixabepilone/Carboplatin/Bevacizumab | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 14/42 (33.3%) | 18/40 (45%) | ||
Blood and lymphatic system disorders | ||||
Hemorrhage, Pulmonary/Upper Respiratory - Hemoptysis | 1/42 (2.4%) | 1 | 0/40 (0%) | 0 |
Cardiac disorders | ||||
Cardiac Ischemia/Infarction | 1/42 (2.4%) | 1 | 0/40 (0%) | 0 |
Supraventricular arrhythmia - Atrial fibrillation | 1/42 (2.4%) | 1 | 1/40 (2.5%) | 1 |
Hypotension | 0/42 (0%) | 0 | 1/40 (2.5%) | 1 |
Pericardial Effusion | 1/42 (2.4%) | 1 | 0/40 (0%) | 0 |
Gastrointestinal disorders | ||||
Dehydration | 1/42 (2.4%) | 1 | 3/40 (7.5%) | 4 |
Vomiting | 1/42 (2.4%) | 1 | 1/40 (2.5%) | 1 |
Perforation, GI | 0/42 (0%) | 0 | 2/40 (5%) | 2 |
General disorders | ||||
Pain - Abdomen | 0/42 (0%) | 0 | 2/40 (5%) | 2 |
Hepatobiliary disorders | ||||
Cholecystitis | 1/42 (2.4%) | 1 | 0/40 (0%) | 0 |
Immune system disorders | ||||
Allergic Reaction | 0/42 (0%) | 0 | 1/40 (2.5%) | 1 |
Febrile Neutropenia | 1/42 (2.4%) | 1 | 0/40 (0%) | 0 |
Neutrophils | 0/42 (0%) | 0 | 1/40 (2.5%) | 1 |
Infections and infestations | ||||
Infection - NOS | 0/42 (0%) | 0 | 2/40 (5%) | 2 |
Infection - Renal/Genitourinary | 0/42 (0%) | 0 | 1/40 (2.5%) | 2 |
Infection - Pneumonia | 1/42 (2.4%) | 1 | 1/40 (2.5%) | 1 |
Metabolism and nutrition disorders | ||||
Hyperglycemia | 1/42 (2.4%) | 1 | 0/40 (0%) | 0 |
Hypokalemia | 1/42 (2.4%) | 1 | 0/40 (0%) | 0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Death | 4/42 (9.5%) | 4 | 1/40 (2.5%) | 1 |
Nervous system disorders | ||||
Seizure | 2/42 (4.8%) | 2 | 0/40 (0%) | 0 |
Neuropathy - Motor | 1/42 (2.4%) | 1 | 0/40 (0%) | 0 |
Syncope | 1/42 (2.4%) | 1 | 0/40 (0%) | 0 |
Neurology - Neurotoxicity | 0/42 (0%) | 0 | 1/40 (2.5%) | 1 |
Encephalopathy | 0/42 (0%) | 0 | 1/40 (2.5%) | 1 |
Psychiatric disorders | ||||
Mental Status | 0/42 (0%) | 0 | 1/40 (2.5%) | 1 |
Psychosis | 0/42 (0%) | 0 | 1/40 (2.5%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||||
Dyspnea | 2/42 (4.8%) | 3 | 1/40 (2.5%) | 1 |
Pneumothorax | 0/42 (0%) | 0 | 1/40 (2.5%) | 1 |
Pulmonary - Bronchitis | 0/42 (0%) | 0 | 1/40 (2.5%) | 1 |
ARDS | 1/42 (2.4%) | 1 | 0/40 (0%) | 0 |
Pleural Effusion | 1/42 (2.4%) | 1 | 0/40 (0%) | 0 |
Surgical and medical procedures | ||||
Wound Complication | 0/42 (0%) | 0 | 1/40 (2.5%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
Ixabepilone/Carboplatin | Ixabepilone/Carboplatin/Bevacizumab | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 42/42 (100%) | 40/40 (100%) | ||
Blood and lymphatic system disorders | ||||
Edema - Limb | 0/42 (0%) | 0 | 10/40 (25%) | 23 |
Hemoglobin | 35/42 (83.3%) | 132 | 30/40 (75%) | 172 |
Hemorrhage - Urinary | 0/42 (0%) | 0 | 6/40 (15%) | 12 |
Hemorrhage - Nose | 0/42 (0%) | 0 | 10/40 (25%) | 22 |
Platelets | 23/42 (54.8%) | 61 | 26/40 (65%) | 83 |
Cardiac disorders | ||||
Hypertension | 0/42 (0%) | 0 | 5/40 (12.5%) | 16 |
Hypotension | 5/42 (11.9%) | 17 | 0/40 (0%) | 0 |
Supraventricular arrhythmia - Atrial fibrillation | 5/42 (11.9%) | 6 | 0/40 (0%) | 0 |
Gastrointestinal disorders | ||||
Anorexia | 13/42 (31%) | 37 | 17/40 (42.5%) | 62 |
Constipation | 17/42 (40.5%) | 39 | 14/40 (35%) | 46 |
Dehydration | 9/42 (21.4%) | 14 | 8/40 (20%) | 12 |
Diarrhea | 12/42 (28.6%) | 31 | 10/40 (25%) | 38 |
Mucositis/Stomatitis | 0/42 (0%) | 0 | 10/40 (25%) | 28 |
Nausea | 23/42 (54.8%) | 56 | 23/40 (57.5%) | 64 |
Taste Alteration | 6/42 (14.3%) | 17 | 12/40 (30%) | 50 |
Vomiting | 18/42 (42.9%) | 32 | 16/40 (40%) | 39 |
General disorders | ||||
Fatigue | 31/42 (73.8%) | 125 | 30/40 (75%) | 210 |
Fever | 0/42 (0%) | 0 | 8/40 (20%) | 12 |
Insomnia | 9/42 (21.4%) | 23 | 12/40 (30%) | 31 |
Pain | 28/42 (66.7%) | 150 | 31/40 (77.5%) | 232 |
Immune system disorders | ||||
Leukocytes | 26/42 (61.9%) | 71 | 28/40 (70%) | 78 |
Neutrophils | 29/42 (69%) | 67 | 28/40 (70%) | 64 |
Infections and infestations | ||||
Infection - NOS | 14/42 (33.3%) | 30 | 12/40 (30%) | 31 |
Metabolism and nutrition disorders | ||||
Alkaline Phosphatase | 6/42 (14.3%) | 8 | 0/40 (0%) | 0 |
Hypercalcemia | 5/42 (11.9%) | 11 | 0/40 (0%) | 0 |
Hyperglycemia | 12/42 (28.6%) | 21 | 5/40 (12.5%) | 10 |
Hyperkalemia | 6/42 (14.3%) | 8 | 0/40 (0%) | 0 |
Hypoalbuminemia | 5/42 (11.9%) | 6 | 0/40 (0%) | 0 |
Hypokalemia | 5/42 (11.9%) | 11 | 6/40 (15%) | 16 |
Hyponatremia | 0/42 (0%) | 0 | 8/40 (20%) | 17 |
Weight Loss | 0/42 (0%) | 0 | 11/40 (27.5%) | 35 |
Musculoskeletal and connective tissue disorders | ||||
Muscle Weakness | 0/42 (0%) | 0 | 5/40 (12.5%) | 18 |
Nervous system disorders | ||||
Dizziness | 9/42 (21.4%) | 17 | 6/40 (15%) | 6 |
Neuropathy - Sensory | 15/42 (35.7%) | 52 | 16/40 (40%) | 91 |
Psychiatric disorders | ||||
Mood Alteration - Anxiety | 0/42 (0%) | 0 | 7/40 (17.5%) | 25 |
Renal and urinary disorders | ||||
Proteinuria | 0/42 (0%) | 0 | 13/40 (32.5%) | 35 |
Respiratory, thoracic and mediastinal disorders | ||||
Cough | 17/42 (40.5%) | 30 | 15/40 (37.5%) | 56 |
Dyspnea | 17/42 (40.5%) | 50 | 18/40 (45%) | 56 |
Nasal/Paranasal Reactions | 7/42 (16.7%) | 14 | 5/40 (12.5%) | 12 |
Skin and subcutaneous tissue disorders | ||||
Alopecia | 15/42 (35.7%) | 52 | 16/40 (40%) | 66 |
Rash/Desquamation | 0/42 (0%) | 0 | 7/40 (17.5%) | 15 |
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 LUN 179