Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Progression-free Survival in the Subgroup of Participants With ßIII-tubulin Positive Tumors |
Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on-study tumor assessment, progression-free survival was censored at the date of randomization. A tumor was considered to be beta III (ßIII)-tubulin positive if 50% or more of the tumor cells had a ßIII-tubulin immunohistochemistry staining intensity equal to or greater than that of the positive control. |
Randomization to disease progression or death (maximum reached: 14.39 months ) |
|
| Secondary |
Progression-free Survival in the Subgroup of Participants With ßIII-tubulin Negative Tumors |
Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on study tumor assessment, progression-free survival was censored at the date of randomization. |
Randomization to disease progression or death (maximum reached: 12.29 months) |
|
| Secondary |
Progression-free Survival in the Overall Population |
Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on study tumor assessment, progression-free survival was censored at the date of randomization. |
Randomization to disease progression or death, assessed to 12.29 months |
|
| Secondary |
Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) |
Response evaluated per Response Evaluaton in Solid Tumor (V1.0) guidelines and assessed using magnetic resonance imaging. Percentage of best response=the total number of participants with the best overall response of CR or PR divided by the total number of randomized participants in that treatment arm. CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. |
At randomization and then every 6 weeks to date of CR, PR, or progression for 6 21-day cycles |
|
| Secondary |
Time to Response |
Time to Response is defined as the time from randomization date until the date of first response (Partial Response [PR] or Complete Response [CR]) |
Randomization to date of first response (PR or CR) |
|
| Secondary |
Number of Participants With Death as Outcome, Drug-related Adverse Events (AEs), Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation, and Drug-related Peripheral Neuropathy |
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable 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 or prolongs hospitalization. Drug-related is defined as possibly, probably, or certainly related to and of unknown relationship to study treatment. |
Days 1 through 21, continuously |
|
| Secondary |
Number of Participants With Hematology Laboratory Results of Grade 3 or 4 |
LLN=lower level of normal. Leukocytes (leukopenia) Grade 1:
| At screening and weekly during 21-day cycle |
|
|
| Secondary |
Number of Participants With Grade 3 or 4 Abnormalities in Liver Function and Urine Laboratory Test Results |
ULN=upper level of normal. Alkaline phosphatase (ALP) Gr 1:>ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN; Aspartate aminotransferase (AST) Gr 1: >ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN |
At screening and within 72 hours of start of 21-day cycle (Cycle 2 and beyond) |
|
| Secondary |
Median Length of Survival in the Overall Population and in the Subgroups of Patients With ßIII-tubulin Positive (ß3T+) and ßIII-tubulin Negative (ß3T-)Tumors |
Overall Survival was computed for all randomized participants and was defined as the time between randomization and death. Participants who did not die at the end of the study were censored at their last known alive date. |
Randomization to death or last known alive date, up to 31.34 months |
|
