Trial Outcomes & Findings for A Phase II, Trial of Ixabepilone Plus Cetuximab as First Line Therapy for Metastatic Pancreatic Cancer (NCT NCT00383149)
NCT ID: NCT00383149
Last Updated: 2016-03-10
Results Overview
The percentage of participants surviving at 6 months was defined as the number of treated participants who had not died prior to 6 months from the date of their first dose divided by the total number of treated participants.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
From time of first dose of study drug through 6 months
Results posted on
2016-03-10
Participant Flow
Of the 58 participants enrolled, 4 were never treated.
Participant milestones
| Measure |
Ixabepilone + Cetuximab
All participants were administered ixabepilone at a starting dose of 32 mg/m\^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
|
|---|---|
|
Overall Study
STARTED
|
54
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
54
|
Reasons for withdrawal
| Measure |
Ixabepilone + Cetuximab
All participants were administered ixabepilone at a starting dose of 32 mg/m\^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
|
|---|---|
|
Overall Study
Adverse Event not Related to Study Drug
|
3
|
|
Overall Study
Death
|
2
|
|
Overall Study
Disease Progression
|
38
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Other
|
1
|
|
Overall Study
Study Drug Toxicity
|
4
|
|
Overall Study
Request to Discontinue Treatment
|
4
|
|
Overall Study
Participant Withdrew Consent
|
1
|
Baseline Characteristics
A Phase II, Trial of Ixabepilone Plus Cetuximab as First Line Therapy for Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Ixabepilone + Cetuximab
n=54 Participants
All participants were administered ixabepilone at a starting dose of 32 mg/m\^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
|
|---|---|
|
Age, Continuous
|
63.0 years
n=5 Participants
|
|
Age, Customized
Age Greater than, equal to 65 years
|
22 participants
n=5 Participants
|
|
Age, Customized
Age less than 65 years
|
32 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From time of first dose of study drug through 6 monthsPopulation: Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. Participants who did not die prior to 6 months but dropped out of the study were not included in the numerator.
The percentage of participants surviving at 6 months was defined as the number of treated participants who had not died prior to 6 months from the date of their first dose divided by the total number of treated participants.
Outcome measures
| Measure |
Ixabepilone + Cetuximab
n=54 Participants
All participants were administered ixabepilone at a starting dose of 32 mg/m\^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
|
Cetuximab
All participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
|
|---|---|---|
|
Percentage of Participants Surviving at 6 Months
|
57.4 percentage of participants
Interval 43.2 to 70.8
|
—
|
SECONDARY outcome
Timeframe: From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression)Population: Response-evaluable participants; all participants with measurable disease who received at least one dose of ixabepilone or cetuximab and who had at least one on-treatment tumor assessment.
Tumor response was assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)= disappearance of all non-target lesions, Partial Response (PR)= at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; Stable Disease (SD)= neither PR nor progressive disease (PD) criteria were met; PD = at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline.
Outcome measures
| Measure |
Ixabepilone + Cetuximab
n=31 Participants
All participants were administered ixabepilone at a starting dose of 32 mg/m\^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
|
Cetuximab
All participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
|
|---|---|---|
|
Best Overall Tumor Response
Participants with Complete Response
|
0 participants
|
—
|
|
Best Overall Tumor Response
Participants with Partial Response
|
4 participants
|
—
|
|
Best Overall Tumor Response
Participants with Stable Disease
|
24 participants
|
—
|
|
Best Overall Tumor Response
Participants with Progressive Disease
|
2 participants
|
—
|
|
Best Overall Tumor Response
Participants with Response Unable to be Determined
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progressionPopulation: Response-evaluable participants; all participants with measurable disease who received at least one dose of ixabepilone or cetuximab and who had at least one on-treatment tumor assessment.
Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants. Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions.
Outcome measures
| Measure |
Ixabepilone + Cetuximab
n=31 Participants
All participants were administered ixabepilone at a starting dose of 32 mg/m\^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
|
Cetuximab
All participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
|
|---|---|---|
|
Percentage of Participants With Objective Tumor Response
|
12.9 percentage of participants
Interval 3.6 to 29.8
|
—
|
SECONDARY outcome
Timeframe: From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progressionPopulation: Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. Participants without disease progression or death were censored at the last tumor assessment.
Progression-Free Survival (PFS) time was defined as the time, in months, from the first dosing date until the date of disease progression or death from any cause.
Outcome measures
| Measure |
Ixabepilone + Cetuximab
n=54 Participants
All participants were administered ixabepilone at a starting dose of 32 mg/m\^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
|
Cetuximab
All participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
|
|---|---|---|
|
Median Progression Free Survival Time
|
3.9 months
Interval 2.6 to 4.4
|
—
|
SECONDARY outcome
Timeframe: From the first dosing date until death (last reported death was 21 months after first dose).Population: Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. Participants without a reported date of death were censored at the last known alive date.
Overall survival time was defined as the time in months from the first dosing date to the date of death.
Outcome measures
| Measure |
Ixabepilone + Cetuximab
n=54 Participants
All participants were administered ixabepilone at a starting dose of 32 mg/m\^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
|
Cetuximab
All participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
|
|---|---|---|
|
Median Overall Survival Time
|
7.6 months
Interval 5.5 to 12.2
|
—
|
SECONDARY outcome
Timeframe: From first date recorded for CR or PR until the first date of disease progression or death (last participant with tumor response progressed 6.5 months after documented response).Population: Response-evaluable participants whose best response was PR or CR. Participants without disease progression or death were censored at the last tumor assessment date.
Duration of response was defined as the number of months from when measurement criteria were first met for CR or PR (whichever was recorded first) until the first date of disease progression or death. Complete Response (CR)= disappearance of all non-target lesions, Partial Response (PR)= at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD.
Outcome measures
| Measure |
Ixabepilone + Cetuximab
n=4 Participants
All participants were administered ixabepilone at a starting dose of 32 mg/m\^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
|
Cetuximab
All participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
|
|---|---|---|
|
Median Duration of Response
|
5.7 months
Interval 2.8 to 6.3
|
—
|
SECONDARY outcome
Timeframe: Time from first dose of study therapy until first date of PR or CR. Maximum time to response was 19 months.Population: Response-evaluable participants whose best response was PR or CR.
Time to response was defined as the number of weeks from first dose of study therapy (ixabepilone or cetuximab) until measurement criteria were first met for PR or CR, whichever status was recorded first. Complete Response (CR)= disappearance of all non-target lesions, Partial Response (PR)= at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD.
Outcome measures
| Measure |
Ixabepilone + Cetuximab
n=4 Participants
All participants were administered ixabepilone at a starting dose of 32 mg/m\^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
|
Cetuximab
All participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
|
|---|---|---|
|
Median Time to Response
|
8.8 weeks
Interval 5.1 to 19.0
|
—
|
SECONDARY outcome
Timeframe: From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.Population: Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. The 53 participants reporting treatment-related AEs included 1 additional participant who also developed Grade 5 viscous intestinal perforation, which was also captured under death within 30 days of last dose category.
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition not necessarily having a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event.
Outcome measures
| Measure |
Ixabepilone + Cetuximab
n=54 Participants
All participants were administered ixabepilone at a starting dose of 32 mg/m\^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
|
Cetuximab
All participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
|
|---|---|---|
|
Number of Participants With Death Within 30 Days of Last Dose, Any Serious Adverse Event (SAE), Any Adverse Event (AE) Leading to Discontinuation (DC), or Any Treatment-related AEs By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr)
Any SAE
|
32 participants
|
—
|
|
Number of Participants With Death Within 30 Days of Last Dose, Any Serious Adverse Event (SAE), Any Adverse Event (AE) Leading to Discontinuation (DC), or Any Treatment-related AEs By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr)
All deaths within 30 days of last dose
|
7 participants
|
—
|
|
Number of Participants With Death Within 30 Days of Last Dose, Any Serious Adverse Event (SAE), Any Adverse Event (AE) Leading to Discontinuation (DC), or Any Treatment-related AEs By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr)
Gr 2 (moderate) AE leading to DC
|
2 participants
|
—
|
|
Number of Participants With Death Within 30 Days of Last Dose, Any Serious Adverse Event (SAE), Any Adverse Event (AE) Leading to Discontinuation (DC), or Any Treatment-related AEs By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr)
Gr 3 (severe) AE leading to DC
|
9 participants
|
—
|
|
Number of Participants With Death Within 30 Days of Last Dose, Any Serious Adverse Event (SAE), Any Adverse Event (AE) Leading to Discontinuation (DC), or Any Treatment-related AEs By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr)
Gr 4 (life-threatening) AE leading to DC
|
3 participants
|
—
|
|
Number of Participants With Death Within 30 Days of Last Dose, Any Serious Adverse Event (SAE), Any Adverse Event (AE) Leading to Discontinuation (DC), or Any Treatment-related AEs By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr)
All AEs leading to DC
|
14 participants
|
—
|
|
Number of Participants With Death Within 30 Days of Last Dose, Any Serious Adverse Event (SAE), Any Adverse Event (AE) Leading to Discontinuation (DC), or Any Treatment-related AEs By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr)
Gr 1 (mild) treatment-related AE
|
4 participants
|
—
|
|
Number of Participants With Death Within 30 Days of Last Dose, Any Serious Adverse Event (SAE), Any Adverse Event (AE) Leading to Discontinuation (DC), or Any Treatment-related AEs By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr)
Gr 2 (moderate) treatment-related AE
|
13 participants
|
—
|
|
Number of Participants With Death Within 30 Days of Last Dose, Any Serious Adverse Event (SAE), Any Adverse Event (AE) Leading to Discontinuation (DC), or Any Treatment-related AEs By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr)
Gr 3 (severe) treatment-related AE
|
25 participants
|
—
|
|
Number of Participants With Death Within 30 Days of Last Dose, Any Serious Adverse Event (SAE), Any Adverse Event (AE) Leading to Discontinuation (DC), or Any Treatment-related AEs By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr)
Gr 4 (life-threatening) treatment-related AE
|
10 participants
|
—
|
|
Number of Participants With Death Within 30 Days of Last Dose, Any Serious Adverse Event (SAE), Any Adverse Event (AE) Leading to Discontinuation (DC), or Any Treatment-related AEs By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr)
Gr 5 (death) treatment-related AE
|
1 participants
|
—
|
|
Number of Participants With Death Within 30 Days of Last Dose, Any Serious Adverse Event (SAE), Any Adverse Event (AE) Leading to Discontinuation (DC), or Any Treatment-related AEs By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr)
All treatment-related AEs
|
53 participants
|
—
|
SECONDARY outcome
Timeframe: From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.Population: Treated participants; all participants who received at least one dose of ixabepilone or cetuximab.
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition not necessarily having a causal relationship with this treatment. Acneform rash and peripheral neuropathy were captured by multiple MedDRA preferred terms. Acneform rash included rash, rash pustular, and rash pruritic preferred terms. Peripheral neuropathy included neuromuscular toxicity, peripheral motor neuropathy, and peripheral sensorimotor neuropathy preferred terms.
Outcome measures
| Measure |
Ixabepilone + Cetuximab
n=54 Participants
All participants were administered ixabepilone at a starting dose of 32 mg/m\^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
|
Cetuximab
All participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
|
|---|---|---|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 1 (mild) hypomagnesemia
|
7 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 2 (moderate) hypomagnesemia
|
4 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 1 (mild) acneform rash
|
21 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 2 (moderate) acneform rash
|
13 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 3 (severe) acneform rash
|
1 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
All acneform rash
|
35 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 1 (mild) fatigue
|
8 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 2 (moderate) fatigue
|
13 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 3 (severe) fatigue
|
8 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 4 (life-threatening) fatigue
|
1 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
All fatigue
|
30 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 1 (mild) alopecia
|
13 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 2 (moderate) alopecia
|
12 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
All alopecia
|
25 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 1 (mild) nausea
|
13 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 2 (moderate) nausea
|
6 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 3 (severe) nausea
|
3 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
All nausea
|
22 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 1 (mild) diarrhea
|
11 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 2 (moderate) diarrhea
|
4 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 3 (severe) diarrhea
|
1 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 4 (life-threatening) diarrhea
|
2 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
All diarrhea
|
18 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 1 (mild) vomiting
|
12 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 2 (moderate) vomiting
|
2 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 3 (severe) vomiting
|
3 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
All vomiting
|
17 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 1 (mild) peripheral neuropathy
|
12 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 2 (moderate) peripheral neuropathy
|
1 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 3 (severe) peripheral neuropathy
|
3 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
All peripheral neuropathy
|
16 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 3 (severe) hypomagnesemia
|
1 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
Gr 4 (life-threatening) hypomagnesemia
|
3 participants
|
—
|
|
Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
All hypomagnesemia
|
15 participants
|
—
|
SECONDARY outcome
Timeframe: From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.Population: Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. n= number of participants with laboratory data available
Laboratory results were graded according to CTC v 3.0. Hematology laboratory evaluations included absolute neutrophil count (ANC), white blood cell count (WBC), platelets (PLT), and hemoglobin (HGB). Liver function laboratory evaluations included alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin. Renal function laboratory evaluation included creatinine.
Outcome measures
| Measure |
Ixabepilone + Cetuximab
n=54 Participants
All participants were administered ixabepilone at a starting dose of 32 mg/m\^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
|
Cetuximab
All participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
|
|---|---|---|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 1 (mild) AST, n=47
|
17 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 3 (severe) AST, n=47
|
2 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 1-4 alkaline phosphatase, n=47
|
29 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 0 (no abnormality) WBC, n=51
|
12 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 1 (mild) WBC, n=51
|
9 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 2 (moderate) WBC, n=51
|
9 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 3 (severe) WBC, n=51
|
17 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 4 (life-threatening) WBC, n=51
|
4 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 1-4 WBC, n=51
|
39 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 3-4 WBC, n=51
|
21 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 0 (no abnormality) ANC, n=50
|
12 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 1 (mild) ANC, n=50
|
8 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 2 (moderate) ANC, n=50
|
12 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 3 (severe) ANC, n=50
|
10 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 4 (life-threatening) ANC, n=50
|
8 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 1-4 ANC, n=50
|
38 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 3-4 ANC, n=51
|
18 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 0 (no abnormality) platelet count, n=51
|
29 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 1 (mild) platelet count, n=51
|
18 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 2 (moderate) platelet count, n=51
|
4 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 1-4 platelet count, n=51
|
2 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 0 (no abnormality) HGB, n=51
|
3 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 1 (mild) HGB, n=51
|
28 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 2 (moderate) HGB, n=51
|
18 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 3 (severe) HGB, n=51
|
2 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 1-4 HGB, n=51
|
48 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 3-4 HGB, n=51
|
2 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 0 (no abnormality) ALT, n=46
|
31 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 1 (mild) ALT, n=46
|
10 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 2 (moderate) ALT, n=46
|
3 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 3 (severe) ALT, n=46
|
2 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 1-4 ALT, n=46
|
15 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 3-4 ALT, n=46
|
2 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 0 (no abnormality) AST, n=47
|
28 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 1-4 AST, n=47
|
19 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 3-4 AST, n=47
|
2 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 0 (no abnormality) alkaline phosphatase, n=47
|
18 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 1 (mild) alkaline phosphatase, n=47
|
20 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 2 (moderate) alkaline phosphatase, n=47
|
5 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 3 (severe) alkaline phosphatase, n=47
|
4 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 3-4 alkaline phosphatase, n=47
|
4 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 0 (no abnormality) total bilirubin, n=48
|
42 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 1 (mild) total bilirubin, n=48
|
1 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 2 (moderate) total bilirubin, n=48
|
1 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 3 (severe) total bilirubin, n=48
|
4 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 1-4 total bilirubin, n=48
|
6 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 3-4 total bilirubin, n=48
|
4 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 0 (no abnormality) creatinine, n=48
|
45 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 1 (mild) creatinine, n=48
|
3 participants
|
—
|
|
Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
Gr 1-4 creatinine, n=48
|
3 participants
|
—
|
SECONDARY outcome
Timeframe: From the first dosing date of Cycle 1 until the last dosing date of the last cycle. Last dosing cycle for a participant was Cycle 21.Population: Since the combination of ixabepilone and cetuximab tested in this trial failed to meet the primary objective of sufficiently improving 6-month survival rate relative to historical control in participants with metastatic pancreatic cancer, dose modification data were collected but not summarized.
Dose reduction of ixabepilone and/or cetuximab due to toxicity was permitted for participants deriving benefit from therapy. Each drug could be dose modified independently of the others. Participants unable to start a cycle due to unacceptable toxicity related to ixabepilone or cetuximab could have therapy delayed for up to 4 weeks. If toxicities prevented the administration of ixabepilone or cetuximab therapy, participants continued receiving the other therapy as scheduled. A dose interruption for ixabepilone or cetuximab was defined as any interruption during the infusion period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: Tissue was available for a small proportion of patients and only 1 out of 11 was EGFR positive, hence EFGR expression analysis was not performed.
EGFR expression was evaluated by means of an immunohistochemical assay using tumor tissue collected prior to receiving first dose.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 3, Week 6, Week 9, Week 12, Week 12, Week 18, Week 24 and every 3 weeks through end of study (participant death/withdrawal from study)Population: Since the combination of ixabepilone and cetuximab tested in this trial failed to meet the primary objective of sufficiently improving 6-month survival rate relative to historical control in participants with metastatic pancreatic cancer, FHSI-8 score data were collected but not summarized.
The FHSI-8 includes eight items representing pancreatic-related symptoms; each symptom is rated by participants on a scale of from 0 to 4. The FHSI-8 total score ranges in value from 0 to 32, with higher scores representing fewer symptoms and lower scores representing more symptoms. Scoring of the FHSI-8 was to be conducted according to the Functional Assessment of Chronic Illness Therapy (FACIT) manual. The symptom assessment was to include treated participants who had baseline measurement and at least one on-study measurement of FHSI-8 questionnaire.
Outcome measures
Outcome data not reported
Adverse Events
Ixabepilone + Cetuximab
Serious events: 32 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ixabepilone + Cetuximab
n=54 participants at risk
All participants were administered ixabepilone at a starting dose of 32 mg/m\^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
|
|---|---|
|
Investigations
WEIGHT DECREASED
|
1.9%
1/54
|
|
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED
|
1.9%
1/54
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
3.7%
2/54
|
|
Cardiac disorders
LEFT VENTRICULAR DYSFUNCTION
|
1.9%
1/54
|
|
Vascular disorders
HYPOTENSION
|
11.1%
6/54
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
3.7%
2/54
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
1.9%
1/54
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
1.9%
1/54
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
1.9%
1/54
|
|
Hepatobiliary disorders
CHOLANGITIS
|
1.9%
1/54
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
1.9%
1/54
|
|
Immune system disorders
HYPERSENSITIVITY
|
5.6%
3/54
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
1.9%
1/54
|
|
Nervous system disorders
SYNCOPE
|
1.9%
1/54
|
|
Nervous system disorders
HEADACHE
|
1.9%
1/54
|
|
Nervous system disorders
PARAESTHESIA
|
1.9%
1/54
|
|
Gastrointestinal disorders
NAUSEA
|
5.6%
3/54
|
|
Gastrointestinal disorders
ASCITES
|
1.9%
1/54
|
|
Gastrointestinal disorders
VOMITING
|
7.4%
4/54
|
|
Gastrointestinal disorders
DIARRHOEA
|
3.7%
2/54
|
|
Gastrointestinal disorders
STOMATITIS
|
1.9%
1/54
|
|
Gastrointestinal disorders
PANCREATITIS
|
1.9%
1/54
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
1.9%
1/54
|
|
Gastrointestinal disorders
ABDOMINAL MASS
|
1.9%
1/54
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
3.7%
2/54
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
1.9%
1/54
|
|
Infections and infestations
INFECTION
|
1.9%
1/54
|
|
Infections and infestations
PNEUMONIA
|
1.9%
1/54
|
|
Infections and infestations
BACTERAEMIA
|
1.9%
1/54
|
|
Infections and infestations
SEPTIC SHOCK
|
1.9%
1/54
|
|
Infections and infestations
LIVER ABSCESS
|
1.9%
1/54
|
|
Infections and infestations
PYELONEPHRITIS
|
1.9%
1/54
|
|
Infections and infestations
ESCHERICHIA BACTERAEMIA
|
1.9%
1/54
|
|
Renal and urinary disorders
RENAL FAILURE
|
1.9%
1/54
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
9.3%
5/54
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
3.7%
2/54
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
1.9%
1/54
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
3.7%
2/54
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
1.9%
1/54
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
3.7%
2/54
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
1.9%
1/54
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
3.7%
2/54
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
1.9%
1/54
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
3.7%
2/54
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
3.7%
2/54
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
1.9%
1/54
|
|
General disorders
CHILLS
|
1.9%
1/54
|
|
General disorders
PYREXIA
|
5.6%
3/54
|
|
General disorders
VISCERAL OEDEMA
|
1.9%
1/54
|
|
General disorders
MULTI-ORGAN FAILURE
|
1.9%
1/54
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA
|
11.1%
6/54
|
Other adverse events
| Measure |
Ixabepilone + Cetuximab
n=54 participants at risk
All participants were administered ixabepilone at a starting dose of 32 mg/m\^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
|
|---|---|
|
Metabolism and nutrition disorders
DEHYDRATION
|
13.0%
7/54
|
|
Investigations
WEIGHT DECREASED
|
20.4%
11/54
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
7.4%
4/54
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
7.4%
4/54
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
11.1%
6/54
|
|
Vascular disorders
HYPOTENSION
|
14.8%
8/54
|
|
Psychiatric disorders
ANXIETY
|
11.1%
6/54
|
|
Psychiatric disorders
INSOMNIA
|
16.7%
9/54
|
|
Psychiatric disorders
DEPRESSION
|
11.1%
6/54
|
|
Immune system disorders
HYPERSENSITIVITY
|
9.3%
5/54
|
|
Nervous system disorders
HEADACHE
|
9.3%
5/54
|
|
Nervous system disorders
DIZZINESS
|
16.7%
9/54
|
|
Nervous system disorders
DYSGEUSIA
|
5.6%
3/54
|
|
Nervous system disorders
PARAESTHESIA
|
9.3%
5/54
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
7.4%
4/54
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
11.1%
6/54
|
|
Gastrointestinal disorders
NAUSEA
|
46.3%
25/54
|
|
Gastrointestinal disorders
ASCITES
|
11.1%
6/54
|
|
Gastrointestinal disorders
VOMITING
|
33.3%
18/54
|
|
Gastrointestinal disorders
DIARRHOEA
|
40.7%
22/54
|
|
Gastrointestinal disorders
FLATULENCE
|
14.8%
8/54
|
|
Gastrointestinal disorders
STOMATITIS
|
14.8%
8/54
|
|
Gastrointestinal disorders
CONSTIPATION
|
37.0%
20/54
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
31.5%
17/54
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
5.6%
3/54
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
7.4%
4/54
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
7.4%
4/54
|
|
Infections and infestations
PARONYCHIA
|
7.4%
4/54
|
|
Infections and infestations
URINARY TRACT INFECTION
|
7.4%
4/54
|
|
Renal and urinary disorders
DYSURIA
|
7.4%
4/54
|
|
Metabolism and nutrition disorders
ANOREXIA
|
31.5%
17/54
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
7.4%
4/54
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
5.6%
3/54
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
5.6%
3/54
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
31.5%
17/54
|
|
Blood and lymphatic system disorders
ANAEMIA
|
25.9%
14/54
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
14.8%
8/54
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
7.4%
4/54
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
20.4%
11/54
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
5.6%
3/54
|
|
Skin and subcutaneous tissue disorders
RASH
|
9.3%
5/54
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
46.3%
25/54
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
13.0%
7/54
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
7.4%
4/54
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
53.7%
29/54
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
5.6%
3/54
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
16.7%
9/54
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
7.4%
4/54
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
5.6%
3/54
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
11.1%
6/54
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
14.8%
8/54
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
7.4%
4/54
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
5.6%
3/54
|
|
General disorders
CHILLS
|
5.6%
3/54
|
|
General disorders
FATIGUE
|
63.0%
34/54
|
|
General disorders
PYREXIA
|
16.7%
9/54
|
|
General disorders
ASTHENIA
|
9.3%
5/54
|
|
General disorders
OEDEMA PERIPHERAL
|
13.0%
7/54
|
|
General disorders
MUCOSAL INFLAMMATION
|
16.7%
9/54
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER