Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung Cancer
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the maximum tolerated dose, dose-limiting toxicity, and recommended Phase II dose of ixabepilone in combination with carboplatin in patients with non-small cell lung cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL
|
Drug: Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL
On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m^2, intravenous (IV) solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 5 mg/min/mL, intravenous IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles.
Other Names:
|
| Active Comparator: Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL
|
Drug: Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL
After all participants in Dose Level 1 (ixabepilone, 32 mg/m^2 + carboplatin, 5 mg/min/mL) have been observed for 1 full 21-day cycle, Dose Level 2(ixabepilone, 32 mg/m^2 + carboplatin, 6 mg/min/mL) opened. On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m^2, IV solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 6 mg/min/mL, IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Dose-limiting Toxicity (DLT) [Days 1 through 21 (Cycle 1)]
DLT is defined as any of the following: Common Terminology Criteria (CTC), Version 3, Grade(Gr) 4 neutropenia (absolute neutrophil count <500 cells/mm^3) for at least 5 days or febrile neutropenia; Gr 4 thrombocytopenia (<25,000 cells/mm^3 or bleeding needing platelet transfusion); Gr 3 or 4 nausea, vomiting, or diarrhea, despite medical intervention; any other drug-related Gr 3 or 4 nonhematologic toxicity, except Gr 3 injection site reaction, fatigue/asthenia, transient arthralgia/myalgia, or transient electrolytes abnormal. Gr 1=Mild; Gr 2=Moderate; Gr 3=Severe; Gr 4=Life-threatening.
- Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of Carboplatin in Combination With Ixabepilone, 32 mg/m^2 [Days 1 through 21 (Cycle 1)]
The MTD was defined as the highest dose evaluated for which less than one sixth of patients experience a DLT in Cycle 1. The recommended phase 2 dose is the MTD defined in Cycle 1, with consideration given to chronic cumulative toxicity occurring at later cycles.
Secondary Outcome Measures
- Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation [Days 1 through 21 (Cycle 1)]
An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires inpatient hospitalization or prolongs existing hospitalization. An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Treatment-related comprises certainly, probably, and possibly related and of unknown relationship to study drug.
- Number of Participants With Grade 3 or Greater Treatment-related AEs [Days 1 through 21 (Cycle 1)]
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. AEs graded according to CTC, Version 3.0. Gr 1=Mild; Gr 2=Moderate; Gr 3=Severe; Gr 4=Life-threatening. Treatment-related comprises certainly, probably, and possibly related and of unknown relationship to study drug.
- Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade [At screening and Days 8 and 15 of Cycle 1 (21 days)]
LLN=lower level of normal; ULN=upper level of normal. Hemoglobin (g/dL; LLN=11.3; ULN=14.9); leukocytes (*10^3 c/uL; LLN=4.1; ULN=6.1); lymphocytes (*10^3 c/uL); neutrophils (absolute), neutrophils + bands (*10^3 c/uL); platelet count (*10^9 c/L; LLN=131; ULN=365) Appendix 7.1.2
- Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade [At screening and Days 8 and 15 of Cycle 1 (21 days)]
ULN=upper limit of normal; LLN=lower limit of normal. Alkaline phosphatase=ALP(LLN=115; ULN=359) (U/L); alanine aminotransferase=ALT (LLN=8; ULN=42)(U/L); aspartate aminotransferase=AST (LLN=13; ULN=33) (U/L); albumin (LLN=3.7; ULN=5.2)(g/dL); bilirubin (LLN=0.3; ULN=1.2)(mg/dL); calcium (LLN=8.7; ULN=10.3)(mg/dL); creatinine (LLN=0.6; ULN=1.1)(mg/dL); potassium (LLN=3.6; ULN=4.9) (mEq/L); sodium (LLN=138; ULN=146) (mEq/L)
- Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade [At screening and Days 8 and 15 of Cycle 1 (21 days)]
Toxicities graded according to CTC, Version 3. Protein Gr 1: <1.0 g/24 hrs (1+); Gr 2: 1.0 to 3.4 g/24 hrs (2+ to 3+ ); Gr 3: >=3.5 g/24 hrs (4+); Gr 4: Nephrotic syndrome. Note: + = qualitative measure of urine chemistry.
- Number of Participants With Abnormalities in Blood Pressure and Heart Rate [At screening and Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22)]
Blood pressure and heart rate obtained before ixabepilone infusion, every 1 hour during and at the end of ixabepilone infusion, and at the end of carboplatin infusion in Cycle 1. For subsequent cycles, vital signs obtained before ixabepilone infusion, at the end of ixabepilone infusion, and at the end of carboplatin infusion. Any new or worsening clinically significant changes since last entry were recorded as appropriate AE or SAE.
- Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status [At screening of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22)]
Participants weighed same day as serum chemistry tests. Body surface area recalculated only if body weight changes >10%. ECOG criteria used to assess disease progression and affects on daily living abilities and to determine appropriate treatment and prognosis. Grade 1=Restricted physical activity but ambulatory and capable of light work; Grade 2=Ambulatory, capable of self care, but unable to carry out any work activities; Grade 3=Capable of limited self care, confined to bed or chair 50% or more of waking hours; Grade 4=Completely disabled, totally confined to bed or chair.
- Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment [Days 1 through 21 (Cycle 1)]
Tumor response was assessed using the RECIST assessment: Complete response (CR)=Disappearance of all clinical and radiologic evidence of target lesions; Partial response (PR)=At least 30% reduction in the sum of the longest diameters of all target lesions; Progressive disease (PD)=At least 20% increase in the sum of the longest diameters of all target lesions; Stable disease (SD)=Neither PR nor PD criteria were met.
- Maximum Observed Plasma Concentration of Ixabepilone [Days 1 to 8 of Cycle 1 (21 days)]
- Time of Maximum Observed Plasma Concentration of Ixabepilone [Days 1 to 8 of Cycle 1 (21 days)]
- Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time of Ixabepilone [Days 1 to 8 of Cycle 1 (21 days)]
- Volume of Distribution at Steady State of Ixabepilone [Days 1 to 8 of Cycle 1 (21 days)]
- Total Body Clearance of Ixabepilone [Days 1 to 8 of Cycle 1 (21 days)]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥20 years
-
Histologic or cytologic diagnosis of advanced non-small cell lung cancer (NSCLC)
-
Advanced NSCLC, defined as stage IIIB (without indications for radiotherapy), stage IV, or recurrent
-
No prior chemotherapy-containing regimens for the treatment of NSCLC
-
Eastern Cooperative Oncology Group performance status of 0-1
-
Life expectancy of at least 12 weeks
-
Accessible for treatment and follow up; patients who could be hospitalized for first 15 days of Cycle 1
-
Adequate recovery from previous systemic therapy (at least 3 weeks for surgery or radiation therapy)
Exclusion Criteria:
-
Women of childbearing potential (WOCBP) unwilling or unable to use an acceptable method to avoid pregnancy for study period and for up to 4 weeks after last dose of study drug
-
Women pregnant or breast feeding
-
Women with a positive pregnancy test result on enrollment or prior to study drug administration
-
Sexually active fertile men not using effective birth control for the entire study period and for up to 3 months after the last dose of study drug if their partners are WOCBP
-
Patients with symptomatic or requiring treatment for brain metastases and/or leptomeningeal metastases
-
Prior radiation must not have included ≥30% of major bone-marrow-containing areas (pelvis, lumbar spine)
-
Common Terminology Criteria (CTC) Grade 2 or greater neuropathy
-
Psychiatric or other disorders rendering the patient incapable of complying with protocol requirements
-
Any concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix (Patients with a history of malignancy but without evidence of disease for 5 years are eligible)
-
Serious uncontrolled medical disorder or active systemic infection that would impair the ability of the subject to receive protocol therapy.
-
Myocardial infarction, unstable angina, or unstable congestive heart failure within 6 months
-
Known history of infection with human immunodeficiency virus
-
Inadequate bone marrow function
-
Inadequate hepatic function
-
Inadequate renal function
-
Known prior severe hypersensitivity reaction (CTC Grade 2 or greater) to agents containing Cremophor®EL
-
Known severe hypersensitivity reaction to agents containing carboplatin and other platinum
-
Prior treatment with an epothilone and/or with platinum
-
History of high-dose chemotherapy with bone marrow transplant or peripheral blood stem cell support within 2 years
-
On treatment with strong Cytochrome P450 3A4 inhibitor
-
Current imprisonment
-
Compulsorily detention for treatment of psychiatric or physical illness
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution | Chuo-Ku | Tokyo | Japan | 104-0045 |
Sponsors and Collaborators
- R-Pharm
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CA163-160
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | After all participants in Dose Level 1 (ixabepilone, 32 mg/m^2 + carboplatin, 5 mg/min/mL) have been observed for 1 full 21-day cycle, Dose Level 2 (ixabepilone, 32 mg/m^2 + carboplatin, 6 mg/min/mL) opened. |
| Arm/Group Title | Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL |
|---|---|---|
| Arm/Group Description | Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle. | After all participants in Dose Level 1 have been observed for 1 full 21-day cycle, Dose Level 2 opened: Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL. infused over 30 minutes on Day 1 of each 21-day cycle. |
| Period Title: Dose Level 1 | ||
| STARTED | 6 | 0 |
| COMPLETED | 3 | 0 |
| NOT COMPLETED | 3 | 0 |
| Period Title: Dose Level 1 | ||
| STARTED | 0 | 6 |
| COMPLETED | 0 | 4 |
| NOT COMPLETED | 0 | 2 |
Baseline Characteristics
| Arm/Group Title | Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Total |
|---|---|---|---|
| Arm/Group Description | Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle. | Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle. | Total of all reporting groups |
| Overall Participants | 6 | 6 | 12 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
6
100%
|
4
66.7%
|
10
83.3%
|
| >=65 years |
0
0%
|
2
33.3%
|
2
16.7%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
51.2
(8.30)
|
57.7
(10.5)
|
54.4
(9.62)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
4
66.7%
|
3
50%
|
7
58.3%
|
| Male |
2
33.3%
|
3
50%
|
5
41.7%
|
| Race/Ethnicity, Customized (Number) [Number] | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Japanese |
6
100%
|
6
100%
|
12
100%
|
Outcome Measures
| Title | Number of Participants With Dose-limiting Toxicity (DLT) |
|---|---|
| Description | DLT is defined as any of the following: Common Terminology Criteria (CTC), Version 3, Grade(Gr) 4 neutropenia (absolute neutrophil count <500 cells/mm^3) for at least 5 days or febrile neutropenia; Gr 4 thrombocytopenia (<25,000 cells/mm^3 or bleeding needing platelet transfusion); Gr 3 or 4 nausea, vomiting, or diarrhea, despite medical intervention; any other drug-related Gr 3 or 4 nonhematologic toxicity, except Gr 3 injection site reaction, fatigue/asthenia, transient arthralgia/myalgia, or transient electrolytes abnormal. Gr 1=Mild; Gr 2=Moderate; Gr 3=Severe; Gr 4=Life-threatening. |
| Time Frame | Days 1 through 21 (Cycle 1) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of either ixabepilone or carboplatin |
| Arm/Group Title | Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL |
|---|---|---|
| Arm/Group Description | Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle. | Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle. |
| Measure Participants | 6 | 6 |
| Number [Participants] |
0
0%
|
1
16.7%
|
| Title | Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of Carboplatin in Combination With Ixabepilone, 32 mg/m^2 |
|---|---|
| Description | The MTD was defined as the highest dose evaluated for which less than one sixth of patients experience a DLT in Cycle 1. The recommended phase 2 dose is the MTD defined in Cycle 1, with consideration given to chronic cumulative toxicity occurring at later cycles. |
| Time Frame | Days 1 through 21 (Cycle 1) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of either ixabepilone or carboplatin |
| Arm/Group Title | All Treated |
|---|---|
| Arm/Group Description | All subjects who received at least 1 dose of either ixabepilone or carboplatin |
| Measure Participants | 12 |
| Number [mg/min/mL] |
6
|
| Title | Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation |
|---|---|
| Description | An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires inpatient hospitalization or prolongs existing hospitalization. An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Treatment-related comprises certainly, probably, and possibly related and of unknown relationship to study drug. |
| Time Frame | Days 1 through 21 (Cycle 1) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of either ixabepilone or carboplatin |
| Arm/Group Title | Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL |
|---|---|---|
| Arm/Group Description | Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle. | Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle. |
| Measure Participants | 6 | 6 |
| Death |
0
0%
|
0
0%
|
| Treatment-related SAEs |
0
0%
|
0
0%
|
| SAEs |
1
16.7%
|
0
0%
|
| AEs |
6
100%
|
6
100%
|
| Treatment-related AEs leading to discontinuation |
1
16.7%
|
2
33.3%
|
| Title | Number of Participants With Grade 3 or Greater Treatment-related AEs |
|---|---|
| Description | An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. AEs graded according to CTC, Version 3.0. Gr 1=Mild; Gr 2=Moderate; Gr 3=Severe; Gr 4=Life-threatening. Treatment-related comprises certainly, probably, and possibly related and of unknown relationship to study drug. |
| Time Frame | Days 1 through 21 (Cycle 1) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All subjects who received at least 1 dose of either ixabepilone or carboplatin |
| Arm/Group Title | Ixabepilone, 32 mg/m^2 + Carboplatin 5 mg/Min/mL | Ixabepilone, 32 mg/m^2 + Carboplatin 6 mg/Min/mL |
|---|---|---|
| Arm/Group Description | Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle. | Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle. |
| Measure Participants | 6 | 6 |
| Neutropenia |
5
83.3%
|
4
66.7%
|
| Leukopenia |
4
66.7%
|
4
66.7%
|
| Anemia |
4
66.7%
|
1
16.7%
|
| Thrombocytopenia |
2
33.3%
|
1
16.7%
|
| Lymphopenia |
2
33.3%
|
0
0%
|
| Nausea |
0
0%
|
1
16.7%
|
| Liver function test abnormality |
0
0%
|
1
16.7%
|
| Deep vein thrombosis |
0
0%
|
1
16.7%
|
| Title | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade |
|---|---|
| Description | LLN=lower level of normal; ULN=upper level of normal. Hemoglobin (g/dL; LLN=11.3; ULN=14.9); leukocytes (*10^3 c/uL; LLN=4.1; ULN=6.1); lymphocytes (*10^3 c/uL); neutrophils (absolute), neutrophils + bands (*10^3 c/uL); platelet count (*10^9 c/L; LLN=131; ULN=365) Appendix 7.1.2 |
| Time Frame | At screening and Days 8 and 15 of Cycle 1 (21 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of either ixabepilone or carboplatin |
| Arm/Group Title | Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL |
|---|---|---|
| Arm/Group Description | Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle. | Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle. |
| Measure Participants | 6 | 6 |
| Hemoglobin: Grade 1 (10.0- LLN) |
0
0%
|
0
0%
|
| Hemoglobin: Grade 2 (8.0-<10.0) |
2
33.3%
|
5
83.3%
|
| Hemoglobin: Grade 3 (6.5-<8.0) |
4
66.7%
|
1
16.7%
|
| Hemoglobin: Grade 4 (<6.5) |
0
0%
|
0
0%
|
| Hemoglobin: Not reported |
0
0%
|
0
0%
|
| Leukocytes: Grade 1 (3.0-<LLN) |
0
0%
|
0
0%
|
| Leukocytes: Grade 2 (2.0-<3.0) |
2
33.3%
|
1
16.7%
|
| Leukocytes: Grade 3 (1.0-<2.0) |
4
66.7%
|
5
83.3%
|
| Leukocytes: Grade 4 (<1.0) |
0
0%
|
0
0%
|
| Leukocytes: Not reported |
0
0%
|
0
0%
|
| Lymphocytes (absolute): Grade 1 (0.8-<1.5) |
4
66.7%
|
1
16.7%
|
| Lymphocytes (absolute): Grade 2 (0.5-<0.8) |
0
0%
|
5
83.3%
|
| Lymphocytes (absolute): Grade 3 (0.2-<0.5) |
2
33.3%
|
0
0%
|
| Lymphocytes (absolute): Grade 4 (<0.2) |
0
0%
|
0
0%
|
| Lymphocytes: Not reported |
0
0%
|
0
0%
|
| Neutrophils (absolute): Grade 1 (1.5-<2.0) |
0
0%
|
1
16.7%
|
| Neutrophils (absolute): Grade 2 (1.0-<1.5) |
1
16.7%
|
0
0%
|
| Neutrophils (absolute): Grade 3 (0.5-<1.0) |
1
16.7%
|
0
0%
|
| Neutrophils (absolute): Grade 4 (<0.5) |
4
66.7%
|
5
83.3%
|
| Neutrophils (absolute): Not reported |
0
0%
|
0
0%
|
| Neutrophils+bands (absolute): Grade 1 (1.5-<2.0) |
0
0%
|
1
16.7%
|
| Neutrophils+bands (absolute): Grade 2 (1.0-<1.5) |
1
16.7%
|
0
0%
|
| Neutrophils+bands (absolute): Grade 3 (0.5-<1.0) |
2
33.3%
|
1
16.7%
|
| Neutrophils+bands (absolute): Grade 4 (<0.5) |
3
50%
|
4
66.7%
|
| Neutrophils+bands (absolute): Not reported |
0
0%
|
0
0%
|
| Platelet count: Grade 1 (75.0-<LLN) |
1
16.7%
|
3
50%
|
| Platelet count: Grade 2 (50.0-<75.0) |
3
50%
|
2
33.3%
|
| Platelet count: Grade 3 (25.0-<50.0) |
2
33.3%
|
1
16.7%
|
| Platelet count: Grade 4 (<25.0) |
0
0%
|
0
0%
|
| Platelet count: Not reported |
0
0%
|
0
0%
|
| Title | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade |
|---|---|
| Description | ULN=upper limit of normal; LLN=lower limit of normal. Alkaline phosphatase=ALP(LLN=115; ULN=359) (U/L); alanine aminotransferase=ALT (LLN=8; ULN=42)(U/L); aspartate aminotransferase=AST (LLN=13; ULN=33) (U/L); albumin (LLN=3.7; ULN=5.2)(g/dL); bilirubin (LLN=0.3; ULN=1.2)(mg/dL); calcium (LLN=8.7; ULN=10.3)(mg/dL); creatinine (LLN=0.6; ULN=1.1)(mg/dL); potassium (LLN=3.6; ULN=4.9) (mEq/L); sodium (LLN=138; ULN=146) (mEq/L) |
| Time Frame | At screening and Days 8 and 15 of Cycle 1 (21 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least 1 dose of either ixabepilone or carboplatin |
| Arm/Group Title | Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL |
|---|---|---|
| Arm/Group Description | Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle. | Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle. |
| Measure Participants | 6 | 6 |
| ALT: Grade 1 ( >1.0-2.5*ULN) |
3
50%
|
2
33.3%
|
| ALT: Grade 2 (>2.5-5.0*ULN) |
2
33.3%
|
1
16.7%
|
| ALT: Grade 3 ( >5.0-20.0*ULN ) |
0
0%
|
1
16.7%
|
| Albumin: Grade 1 (<LLN-3.0) |
4
66.7%
|
4
66.7%
|
| ALP: Grade 1 ( >1.0-2.5*ULN) |
0
0%
|
4
66.7%
|
| AST: Grade 1 ( >1.0-2.5*ULN) |
4
66.7%
|
3
50%
|
| AST: Grade 2 (>2.5-5.0*ULN) |
1
16.7%
|
1
16.7%
|
| Bilirubin: Grade 1 (>1.0-1.5*ULN) |
1
16.7%
|
1
16.7%
|
| Bilirubin: Grade 2 (>1.5-3.0*ULN) |
1
16.7%
|
0
0%
|
| Calcium: Grade 1 (8.0-<LLN or >ULN -11.5) |
5
83.3%
|
4
66.7%
|
| Creatinine: Grade 1 (>1.0-1.5*ULN) |
0
0%
|
2
33.3%
|
| Potassium: Grade 1 (3.0-<LLN or >ULN-5.5) |
3
50%
|
1
16.7%
|
| Sodium: Grade 1 (130-<LLN or >ULN-150) |
4
66.7%
|
5
83.3%
|
| Title | Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade |
|---|---|
| Description | Toxicities graded according to CTC, Version 3. Protein Gr 1: <1.0 g/24 hrs (1+); Gr 2: 1.0 to 3.4 g/24 hrs (2+ to 3+ ); Gr 3: >=3.5 g/24 hrs (4+); Gr 4: Nephrotic syndrome. Note: + = qualitative measure of urine chemistry. |
| Time Frame | At screening and Days 8 and 15 of Cycle 1 (21 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL |
|---|---|---|
| Arm/Group Description | Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle. | Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle. |
| Measure Participants | 6 | 6 |
| Protein (Grade 1) |
2
33.3%
|
2
33.3%
|
| Protein (Grade 2) |
3
50%
|
0
0%
|
| Protein (Grade 3) |
0
0%
|
0
0%
|
| Protein (Grade 4) |
0
0%
|
0
0%
|
| Not reported |
0
0%
|
0
0%
|
| Title | Number of Participants With Abnormalities in Blood Pressure and Heart Rate |
|---|---|
| Description | Blood pressure and heart rate obtained before ixabepilone infusion, every 1 hour during and at the end of ixabepilone infusion, and at the end of carboplatin infusion in Cycle 1. For subsequent cycles, vital signs obtained before ixabepilone infusion, at the end of ixabepilone infusion, and at the end of carboplatin infusion. Any new or worsening clinically significant changes since last entry were recorded as appropriate AE or SAE. |
| Time Frame | At screening and Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL |
|---|---|---|
| Arm/Group Description | Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle. | Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle. |
| Measure Participants | 6 | 6 |
| Blood pressure |
0
0%
|
0
0%
|
| Heart rate |
0
0%
|
0
0%
|
| Title | Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status |
|---|---|
| Description | Participants weighed same day as serum chemistry tests. Body surface area recalculated only if body weight changes >10%. ECOG criteria used to assess disease progression and affects on daily living abilities and to determine appropriate treatment and prognosis. Grade 1=Restricted physical activity but ambulatory and capable of light work; Grade 2=Ambulatory, capable of self care, but unable to carry out any work activities; Grade 3=Capable of limited self care, confined to bed or chair 50% or more of waking hours; Grade 4=Completely disabled, totally confined to bed or chair. |
| Time Frame | At screening of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL |
|---|---|---|
| Arm/Group Description | Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle. | Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle. |
| Measure Participants | 6 | 6 |
| Blood pressure |
0
0%
|
0
0%
|
| Heart rate |
0
0%
|
0
0%
|
| Weight |
0
0%
|
0
0%
|
| ECOG performance status |
0
0%
|
0
0%
|
| Title | Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment |
|---|---|
| Description | Tumor response was assessed using the RECIST assessment: Complete response (CR)=Disappearance of all clinical and radiologic evidence of target lesions; Partial response (PR)=At least 30% reduction in the sum of the longest diameters of all target lesions; Progressive disease (PD)=At least 20% increase in the sum of the longest diameters of all target lesions; Stable disease (SD)=Neither PR nor PD criteria were met. |
| Time Frame | Days 1 through 21 (Cycle 1) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants with measurable disease at baseline, as determined by investigator |
| Arm/Group Title | Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL |
|---|---|---|
| Arm/Group Description | Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle. | Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle. |
| Measure Participants | 4 | 6 |
| CR |
0
0%
|
0
0%
|
| PR |
2
33.3%
|
1
16.7%
|
| PD |
2
33.3%
|
0
0%
|
| SD |
0
0%
|
4
66.7%
|
| Unable to be assessed (patient discontinuation) |
0
0%
|
1
16.7%
|
| Title | Maximum Observed Plasma Concentration of Ixabepilone |
|---|---|
| Description | |
| Time Frame | Days 1 to 8 of Cycle 1 (21 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles |
| Arm/Group Title | Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL |
|---|---|---|
| Arm/Group Description | Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle. | Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle. |
| Measure Participants | 6 | 6 |
| Geometric Mean (Standard Deviation) [ng/mL] |
195.77
(45.89)
|
250.32
(76.17)
|
| Title | Time of Maximum Observed Plasma Concentration of Ixabepilone |
|---|---|
| Description | |
| Time Frame | Days 1 to 8 of Cycle 1 (21 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles |
| Arm/Group Title | Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL |
|---|---|---|
| Arm/Group Description | Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle. | Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle. |
| Measure Participants | 6 | 6 |
| Mean (Standard Deviation) [Hours] |
2.61
(0.88)
|
2.43
(1.03)
|
| Title | Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time of Ixabepilone |
|---|---|
| Description | |
| Time Frame | Days 1 to 8 of Cycle 1 (21 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles |
| Arm/Group Title | Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL |
|---|---|---|
| Arm/Group Description | Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle. | Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle. |
| Measure Participants | 6 | 6 |
| Geometric Mean (Standard Deviation) [ng*h/mL] |
1542.11
(585.29)
|
2135.93
(1246.08)
|
| Title | Volume of Distribution at Steady State of Ixabepilone |
|---|---|
| Description | |
| Time Frame | Days 1 to 8 of Cycle 1 (21 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles |
| Arm/Group Title | Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL |
|---|---|---|
| Arm/Group Description | Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle. | Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle. |
| Measure Participants | 6 | 6 |
| Mean (Standard Deviation) [Liters] |
1131.02
(373)
|
1122.82
(477)
|
| Title | Total Body Clearance of Ixabepilone |
|---|---|
| Description | |
| Time Frame | Days 1 to 8 of Cycle 1 (21 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles |
| Arm/Group Title | Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL |
|---|---|---|
| Arm/Group Description | Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle. | Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle. |
| Measure Participants | 6 | 6 |
| Mean (Standard Deviation) [Liters/hour] |
33.64
(11)
|
25.20
(8)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Ixabepilone, 32 mg/m2 + Carboplatin 5 mg/Min/mL | Ixabepilone, 32 mg/m2 + Carboplatin 6 mg/Min/mL | ||
| Arm/Group Description | Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle. | Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle. | ||
All Cause Mortality |
||||
| Ixabepilone, 32 mg/m2 + Carboplatin 5 mg/Min/mL | Ixabepilone, 32 mg/m2 + Carboplatin 6 mg/Min/mL | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Ixabepilone, 32 mg/m2 + Carboplatin 5 mg/Min/mL | Ixabepilone, 32 mg/m2 + Carboplatin 6 mg/Min/mL | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/6 (16.7%) | 0/6 (0%) | ||
| Vascular disorders | ||||
| SUPERIOR VENA CAVAL OCCLUSION | 1/6 (16.7%) | 0/6 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Ixabepilone, 32 mg/m2 + Carboplatin 5 mg/Min/mL | Ixabepilone, 32 mg/m2 + Carboplatin 6 mg/Min/mL | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/6 (100%) | 6/6 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 6/6 (100%) | 6/6 (100%) | ||
| Leukopenia | 6/6 (100%) | 6/6 (100%) | ||
| Lymphopenia | 2/6 (33.3%) | 4/6 (66.7%) | ||
| Neutropenia | 6/6 (100%) | 6/6 (100%) | ||
| Thrombocytopenia | 6/6 (100%) | 6/6 (100%) | ||
| Cardiac disorders | ||||
| Palpitations | 1/6 (16.7%) | 0/6 (0%) | ||
| Eye disorders | ||||
| Asthenopia | 0/6 (0%) | 1/6 (16.7%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 6/6 (100%) | 6/6 (100%) | ||
| Vomiting | 4/6 (66.7%) | 3/6 (50%) | ||
| Diarrhoea | 0/6 (0%) | 2/6 (33.3%) | ||
| Dysphagia | 1/6 (16.7%) | 0/6 (0%) | ||
| Toothache | 1/6 (16.7%) | 0/6 (0%) | ||
| Stomatitis | 3/6 (50%) | 0/6 (0%) | ||
| Constipation | 5/6 (83.3%) | 2/6 (33.3%) | ||
| Abdominal discomfort | 0/6 (0%) | 1/6 (16.7%) | ||
| Abdominal pain upper | 1/6 (16.7%) | 0/6 (0%) | ||
| General disorders | ||||
| Oedema | 1/6 (16.7%) | 0/6 (0%) | ||
| Fatigue | 5/6 (83.3%) | 4/6 (66.7%) | ||
| Malaise | 1/6 (16.7%) | 0/6 (0%) | ||
| Pyrexia | 1/6 (16.7%) | 1/6 (16.7%) | ||
| Injection site reaction | 1/6 (16.7%) | 0/6 (0%) | ||
| Infections and infestations | ||||
| Nasopharyngitis | 0/6 (0%) | 1/6 (16.7%) | ||
| Urinary tract infection | 1/6 (16.7%) | 0/6 (0%) | ||
| Investigations | ||||
| Protein urine | 5/6 (83.3%) | 1/6 (16.7%) | ||
| Weight decreased | 1/6 (16.7%) | 3/6 (50%) | ||
| Blood urine present | 3/6 (50%) | 3/6 (50%) | ||
| Glucose urine present | 0/6 (0%) | 1/6 (16.7%) | ||
| Blood sodium decreased | 0/6 (0%) | 3/6 (50%) | ||
| Blood sodium increased | 1/6 (16.7%) | 0/6 (0%) | ||
| Blood albumin decreased | 2/6 (33.3%) | 1/6 (16.7%) | ||
| Protein total decreased | 1/6 (16.7%) | 0/6 (0%) | ||
| Blood bilirubin increased | 2/6 (33.3%) | 1/6 (16.7%) | ||
| Blood potassium increased | 2/6 (33.3%) | 0/6 (0%) | ||
| Blood creatinine increased | 0/6 (0%) | 1/6 (16.7%) | ||
| Liver function test abnormal | 1/6 (16.7%) | 2/6 (33.3%) | ||
| Alanine aminotransferase increased | 4/6 (66.7%) | 2/6 (33.3%) | ||
| Aspartate aminotransferase increased | 5/6 (83.3%) | 3/6 (50%) | ||
| Blood lactate dehydrogenase increased | 1/6 (16.7%) | 1/6 (16.7%) | ||
| Metabolism and nutrition disorders | ||||
| Dehydration | 0/6 (0%) | 1/6 (16.7%) | ||
| Decreased appetite | 6/6 (100%) | 5/6 (83.3%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Myalgia | 6/6 (100%) | 6/6 (100%) | ||
| Back pain | 1/6 (16.7%) | 1/6 (16.7%) | ||
| Arthralgia | 6/6 (100%) | 5/6 (83.3%) | ||
| Musculoskeletal chest pain | 1/6 (16.7%) | 0/6 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Cancer pain | 1/6 (16.7%) | 0/6 (0%) | ||
| Nervous system disorders | ||||
| Headache | 0/6 (0%) | 1/6 (16.7%) | ||
| Dizziness | 2/6 (33.3%) | 0/6 (0%) | ||
| Dysgeusia | 2/6 (33.3%) | 4/6 (66.7%) | ||
| Dysarthria | 0/6 (0%) | 1/6 (16.7%) | ||
| Peripheral sensory neuropathy | 6/6 (100%) | 5/6 (83.3%) | ||
| Psychiatric disorders | ||||
| Insomnia | 1/6 (16.7%) | 0/6 (0%) | ||
| Depressed mood | 0/6 (0%) | 1/6 (16.7%) | ||
| Sleep disorder | 1/6 (16.7%) | 0/6 (0%) | ||
| Renal and urinary disorders | ||||
| Glycosuria | 1/6 (16.7%) | 0/6 (0%) | ||
| Pollakiuria | 1/6 (16.7%) | 0/6 (0%) | ||
| Proteinuria | 1/6 (16.7%) | 1/6 (16.7%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 1/6 (16.7%) | 0/6 (0%) | ||
| Hiccups | 0/6 (0%) | 1/6 (16.7%) | ||
| Dyspnoea | 1/6 (16.7%) | 0/6 (0%) | ||
| Epistaxis | 1/6 (16.7%) | 2/6 (33.3%) | ||
| Productive cough | 0/6 (0%) | 1/6 (16.7%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Rash | 3/6 (50%) | 1/6 (16.7%) | ||
| Eczema | 1/6 (16.7%) | 0/6 (0%) | ||
| Alopecia | 6/6 (100%) | 5/6 (83.3%) | ||
| Pruritus | 1/6 (16.7%) | 1/6 (16.7%) | ||
| Vascular disorders | ||||
| Haemorrhage | 1/6 (16.7%) | 0/6 (0%) | ||
| Hypotension | 0/6 (0%) | 1/6 (16.7%) | ||
| Hypertension | 0/6 (0%) | 1/6 (16.7%) | ||
| Deep vein thrombosis | 0/6 (0%) | 1/6 (16.7%) | ||
| Superior vena caval occlusion | 1/6 (16.7%) | 0/6 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
| Name/Title | BMS Study Director |
|---|---|
| Organization | Bristol-Myers Squibb |
| Phone | |
| Clinical.Trials@bms.com |
- CA163-160