Trial Outcomes & Findings for Tipifarnib and Radiation Therapy in Treating Young Patients With Brainstem Glioma (NCT NCT00079339)
NCT ID: NCT00079339
Last Updated: 2014-05-15
Results Overview
The dose limiting toxicity (DLT) analysis population consists of phase I participants who developed DLT during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
51 participants
Primary outcome timeframe
Day 1 of tipifarnib therapy to week 8
Results posted on
2014-05-15
Participant Flow
Participants from PBTC member institutions were enrolled on the phase I component between 01/30/2004 and 01/19/2006. The phase II component of the study opened on 06/02/2006 and completed accrual on 12/26/2007.
Participant milestones
| Measure |
Tipifarnib 100-mg/m2
Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study only.
|
Tipifarnib 125-mg/m2
Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II.
|
Tipifarnib 150-mg/m2
Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study only.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
40
|
6
|
|
Overall Study
Enrolled in Phase I
|
5
|
6
|
6
|
|
Overall Study
Maximum Tolerated Dose (MTD) Estimation
|
3
|
6
|
5
|
|
Overall Study
Enrolled in Phase II
|
0
|
40
|
0
|
|
Overall Study
COMPLETED
|
0
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
39
|
6
|
Reasons for withdrawal
| Measure |
Tipifarnib 100-mg/m2
Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study only.
|
Tipifarnib 125-mg/m2
Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II.
|
Tipifarnib 150-mg/m2
Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study only.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
7
|
2
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Non-compliance
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
1
|
|
Overall Study
Disease progression
|
3
|
28
|
2
|
Baseline Characteristics
Tipifarnib and Radiation Therapy in Treating Young Patients With Brainstem Glioma
Baseline characteristics by cohort
| Measure |
Tipifarnib 100-mg/m2
n=5 Participants
Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study only.
|
Tipifarnib 125-mg/m2
n=40 Participants
Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II.
|
Tipifarnib 150-mg/m2
n=6 Participants
Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study only.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
5.87 years
n=5 Participants
|
5.48 years
n=7 Participants
|
5.84 years
n=5 Participants
|
5.72 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
40 participants
n=7 Participants
|
6 participants
n=5 Participants
|
51 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 of tipifarnib therapy to week 8Population: Per protocol, participants included phase I participants who developed dose-limiting toxicities during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without dose-limiting toxicities.
The dose limiting toxicity (DLT) analysis population consists of phase I participants who developed DLT during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD.
Outcome measures
| Measure |
Tipifarnib 100-mg/m2
n=3 Participants
Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study.
|
Tipifarnib 125-mg/m2
n=6 Participants
Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II.
|
Tipifarnib 150-mg/m2
n=5 Participants
Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study.
|
|---|---|---|---|
|
Number of Participants in the Phase I Component With Dose-limiting Toxicities (DLTs) Observed During the First 8 Weeks (Courses 1 and 2) of Tipifarnib Therapy
|
0 Participants
|
1 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Assessed before the first dose of tipifarnib, every 8 weeks for the first 48 weeks, and then every 12 weeks.Population: Per protocol 40 participants who received at least one dose of tipifarnib were needed for this objective. The analysis population consists of phase I participants treated at the maximum tolerated dose (MTD) and the participants enrolled to the phase II part.
PFS was defined as the interval from initiation of treatment to the earliest of disease progression (tumor increase of 25% over baseline tumor measurement; appearance of new lesion(s); or progressive/worsening neurological status) or death for patients who failed, or to the last date of follow up for patients without failure.
Outcome measures
| Measure |
Tipifarnib 100-mg/m2
n=40 Participants
Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study.
|
Tipifarnib 125-mg/m2
Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II.
|
Tipifarnib 150-mg/m2
Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study.
|
|---|---|---|---|
|
Progression-free Survival (PFS)
|
6.8 Months
Interval 0.2 to 18.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and two weeks post completion of radiationPopulation: The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline perfusion ratio value and a second perfusion ratio value measured at approximately 8 weeks after starting treatment.
This study attempted to investigate in an exploratory manner the effect of treatment on changes in neuroimaging meaurements. Neuroimaging changes may have some association with outcome (response, survival, etc.). Perfusion values are obtained from magnetic resonance perfusion imaging and were measured at baseline, every 8 weeks for the first 48 weeks, and then every 12 weeks until treatment is discontinued.
Outcome measures
| Measure |
Tipifarnib 100-mg/m2
n=19 Participants
Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study.
|
Tipifarnib 125-mg/m2
Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II.
|
Tipifarnib 150-mg/m2
Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study.
|
|---|---|---|---|
|
Change From Baseline in Perfusion Ratio at Two Weeks After Completion of Radiation
|
-.42 Ratio
Interval -7.35 to 4.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and two weeks post completion of radiationPopulation: The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline diffusion ratio value and a second diffusion ratio value measured at approximately 8 weeks after starting treatment.
This study attempted to investigate in an exploratory manner the effect of treatment on changes in neuroimaging meaurements. Neuroimaging changes may have some association with outcome (response, survival, etc.). Diffusion values are obtained from magnetic resonance diffusion imaging and were measured at baseline, every 8 weeks for the first 48 weeks, and then every 12 weeks until treatment is discontinued.
Outcome measures
| Measure |
Tipifarnib 100-mg/m2
n=35 Participants
Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study.
|
Tipifarnib 125-mg/m2
Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II.
|
Tipifarnib 150-mg/m2
Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study.
|
|---|---|---|---|
|
Change From Baseline in Diffusion Ratio at Two Weeks After Completion of Radiation.
|
-.13 Ratio
Interval -1.61 to 0.93
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and two weeks post completion of radiationPopulation: The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline volume FLAIR value and a second volume FLAIR value measured at approximately 8 weeks after starting treatment.
This study attempted to investigate in an exploratory manner the effect of treatment on changes in various neuroimaging variables. Neuroimaging changes may have some association with outcome (response, survival, etc.). Volume FLAIR is one parameter obtained from standard magnetic resonance imaging (MRI) studies of the brain. Volume FLAIR was obtained at baseline and within two weeks after completion of radiation.
Outcome measures
| Measure |
Tipifarnib 100-mg/m2
n=33 Participants
Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study.
|
Tipifarnib 125-mg/m2
Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II.
|
Tipifarnib 150-mg/m2
Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study.
|
|---|---|---|---|
|
Change From Baseline in Volume FLAIR at Two Weeks After Completion of Radiation
|
-12.45 cubic centimeters
Interval -29.45 to 7.86
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline PET scan.
This study attempts to characterize neuroimaging parameters from positron emission tomography. For each patient, the axial image through the tumor containing the maximum activity per pixel corresponding to the highest FluoroDeoxyGlucose (FDG) uptake was identified and a region of interest (ROI) was drawn based on the FDG definition of the tumor. The mean pixel values within the tumor ROI were normalized by those for normal gray matter to provide ratios of tumor/gray matter. Each patient has a mean tumor to gray matter ratio value and the median of these values across patients is reported.
Outcome measures
| Measure |
Tipifarnib 100-mg/m2
n=14 Participants
Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study.
|
Tipifarnib 125-mg/m2
Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II.
|
Tipifarnib 150-mg/m2
Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study.
|
|---|---|---|---|
|
Mean Tumor to Gray Matter Ratio Measured at Baseline
|
.64 Ratio
Interval 0.42 to 1.17
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline PET scan.
This study attempts to characterize neuroimaging parameters from positron emission tomography. For each patient, the axial image through the tumor containing the maximum activity per pixel corresponding to the highest FluoroDeoxyGlucose (FDG) uptake was identified and a region of interest (ROI) was drawn based on the FDG definition of the tumor. The mean pixel values within the tumor ROI were normalized by those for normal white matter to provide ratios of tumor/white matter. Each patient has a mean tumor to white matter ratio value and the median of these values across patients is reported.
Outcome measures
| Measure |
Tipifarnib 100-mg/m2
n=14 Participants
Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study.
|
Tipifarnib 125-mg/m2
Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II.
|
Tipifarnib 150-mg/m2
Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study.
|
|---|---|---|---|
|
Mean Tumor to White Matter Ratio Measured at Baseline
|
1.44 Ratio
Interval 1.17 to 1.91
|
—
|
—
|
Adverse Events
Tipifarnib 100-mg/m2
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Tipifarnib 125-mg/m2
Serious events: 29 serious events
Other events: 40 other events
Deaths: 0 deaths
Tipifarnib 150-mg/m2
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tipifarnib 100-mg/m2
n=5 participants at risk
Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study only.
|
Tipifarnib 125-mg/m2
n=40 participants at risk
Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II.
|
Tipifarnib 150-mg/m2
n=6 participants at risk
Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study only.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
32.5%
13/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
5.0%
2/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Cardiac disorders
Hypertension
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Nervous system disorders
Hemorrhage, CNS
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
7.5%
3/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Renal and urinary disorders
Hemorrhage, GU
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Surgical and medical procedures
Hemorrhage/bleeding associated with surgery, intra-operative or postoperative
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Infections and infestations
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
5.0%
2/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
7.5%
3/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
5.0%
2/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
5.0%
2/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
Alkalosis (metabolic or respiratory)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
GGT (gamma-Glutamyl transpeptidase)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Psychiatric disorders
Somnolence/depressed level of consciousness
|
60.0%
3/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
10.0%
4/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Nervous system disorders
Ataxia (incoordination)
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
7.5%
3/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Nervous system disorders
Hydrocephalus
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
7.5%
3/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Nervous system disorders
Neuropathy: cranial
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Nervous system disorders
Neuropathy: motor
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Nervous system disorders
Seizure
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
5.0%
2/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Nervous system disorders
Apnea
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Nervous system disorders
Laryngeal nerve dysfunction
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Psychiatric disorders
Mood alteration
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Nervous system disorders
Neurology - Other (Specify, __)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Eye disorders
Eyelid dysfunction
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Renal and urinary disorders
Pain - Kidney
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
General disorders
Pain - Head/Headache
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
5.0%
2/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
5.0%
2/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Renal and urinary disorders
Obstruction, GU
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
General disorders
Death not associated with CTCAE term
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
Other adverse events
| Measure |
Tipifarnib 100-mg/m2
n=5 participants at risk
Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study only.
|
Tipifarnib 125-mg/m2
n=40 participants at risk
Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II.
|
Tipifarnib 150-mg/m2
n=6 participants at risk
Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.
Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.
All participants treated at this dose level were enrolled to the phase I part of the study only.
|
|---|---|---|---|
|
Eye disorders
Vision-photophobia
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
25.0%
10/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
50.0%
3/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
60.0%
3/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
72.5%
29/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
33.3%
2/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
80.0%
4/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
62.5%
25/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
66.7%
4/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
50.0%
20/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
50.0%
3/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Blood and lymphatic system disorders
Platelets
|
60.0%
3/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
30.0%
12/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
50.0%
3/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
40.0%
2/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
25.0%
10/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
33.3%
2/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Cardiac disorders
Hypertension
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
17.5%
7/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
40.0%
2/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
45.0%
18/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
50.0%
3/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
7.5%
3/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
General disorders
Weight gain
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
5.0%
2/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
General disorders
Weight loss
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
7.5%
3/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
60.0%
3/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
37.5%
15/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
33.3%
2/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
40.0%
2/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
17.5%
7/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
33.3%
2/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
17.5%
7/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
12.5%
5/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
12.5%
5/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
33.3%
2/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
7.5%
3/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Endocrine disorders
Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity, cutaneous striae)
|
40.0%
2/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
32.5%
13/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
33.3%
2/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Gastrointestinal disorders
Vomiting
|
60.0%
3/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
75.0%
30/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
50.0%
3/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
42.5%
17/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
33.3%
2/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
25.0%
10/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
33.3%
2/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
25.0%
10/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
20.0%
8/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
50.0%
3/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
17.5%
7/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
33.3%
2/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Gastrointestinal disorders
Constipation
|
40.0%
2/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
45.0%
18/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
66.7%
4/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Nervous system disorders
Hemorrhage, CNS
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
15.0%
6/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
5.0%
2/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
60.0%
3/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
55.0%
22/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
50.0%
3/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
60.0%
3/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
40.0%
16/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
50.0%
3/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
40.0%
2/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
42.5%
17/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
50.0%
3/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
60.0%
3/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
27.5%
11/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
33.3%
2/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
40.0%
2/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
32.5%
13/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
80.0%
4/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
20.0%
8/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
50.0%
3/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
40.0%
2/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
30.0%
12/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
30.0%
12/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
25.0%
10/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
20.0%
8/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
17.5%
7/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
GGT (gamma-Glutamyl transpeptidase)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
12.5%
5/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
10.0%
4/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
10.0%
4/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
7.5%
3/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other (Specify, __)
|
40.0%
2/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
7.5%
3/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Nervous system disorders
Ataxia (incoordination)
|
40.0%
2/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
72.5%
29/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
50.0%
3/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Nervous system disorders
Neuropathy: cranial
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Nervous system disorders
Neuropathy: motor
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
30.0%
12/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
50.0%
3/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
20.0%
8/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
33.3%
2/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
20.0%
8/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Psychiatric disorders
Mood alteration - Depression
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
7.5%
3/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Nervous system disorders
Neuropathy: sensory
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
10.0%
4/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Nervous system disorders
Pyramidal tract dysfunction (e.g., increased tone, hyperreflexia, positive Babinski, decreased fine
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
12.5%
5/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Psychiatric disorders
Somnolence/depressed level of consciousness
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
10.0%
4/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Nervous system disorders
Tremor
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
10.0%
4/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Psychiatric disorders
Personality/behavioral
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
5.0%
2/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
33.3%
2/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Psychiatric disorders
Mood alteration - Agitation
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
12.5%
5/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Eye disorders
Ophthalmoplegia/diplopia (double vision)
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
32.5%
13/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Eye disorders
Nystagmus
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
25.0%
10/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Eye disorders
Vision-blurred vision
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
General disorders
Pain - Head/headache
|
40.0%
2/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
57.5%
23/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
66.7%
4/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
General disorders
Pain - Abdomen NOS
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
20.0%
8/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
33.3%
2/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
General disorders
Pain - Extremity-limb
|
40.0%
2/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
12.5%
5/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
33.3%
2/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
General disorders
Pain - Throat/pharynx/larynx
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
10.0%
4/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
General disorders
Pain - Back
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
7.5%
3/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
General disorders
Pain - Middle ear
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
7.5%
3/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
General disorders
Pain - Eye
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
General disorders
Pain - Muscle
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
33.3%
2/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
2/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
20.0%
8/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
50.0%
3/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
10.0%
4/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Renal and urinary disorders
Incontinence, urinary
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
5.0%
2/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
5.0%
2/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
60.0%
3/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
35.0%
14/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
50.0%
3/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
General disorders
Pain - Stomach
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Eye disorders
Ocular surface disease
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
2.5%
1/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
General disorders
Sweating
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Infections and infestations
Febrile neutropenia (fever of unknown origin)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Infections and infestations
Infection with unknown ANC
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Infections and infestations
Opportunistic infection associated with >=Grade 2 Lymphopenia
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Musculoskeletal and connective tissue disorders
Extremity-lower (gait/walking)
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Musculoskeletal and connective tissue disorders
Extremity-upper (function)
|
20.0%
1/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
General disorders
Pain - Chest/thorax NOS
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
General disorders
Pain - Neck
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/5 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
0.00%
0/40 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
16.7%
1/6 • Clinical and laboratory studies to assess adverse events were scheduled pre-treatment, weekly during the first 8 weeks, every 2 weeks for courses 3 -13, and every 12 weeks for courses 14-26. Additional studies were done at the investigator's discretion.
|
Additional Information
Pediatric Brain Tumor Consortium (James M. Boyett, Ph.D)
Pediatric Brain Tumor Consortium
Phone: 901-595-4986
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60