Tipifarnib 125-mg/m2 [clinicaltrials_resource:NCT00079339/group/P2]
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.
participant flow for clinicaltrials:NCT00079339 [clinicaltrials_resource:4ab629d77523405ad01b44b0c6badf1b]participant counts in P2 for milestone 2 of NCT00079339 [clinicaltrials_resource:NCT00079339/milestone/1/p/2]participant counts in P2 for milestone 3 of NCT00079339 [clinicaltrials_resource:NCT00079339/milestone/2/p/2]participant counts in P2 for milestone 4 of NCT00079339 [clinicaltrials_resource:NCT00079339/milestone/3/p/2]participant counts in P2 for milestone 5 of NCT00079339 [clinicaltrials_resource:NCT00079339/milestone/4/p/2]participant counts in P2 for milestone 6 of NCT00079339 [clinicaltrials_resource:NCT00079339/milestone/5/p/2]participant counts in P2 for milestone 7 of NCT00079339 [clinicaltrials_resource:NCT00079339/milestone/6/p/2]Adverse Event [clinicaltrials_resource:NCT00079339/withdraw/1]Death [clinicaltrials_resource:NCT00079339/withdraw/2]Non-compliance [clinicaltrials_resource:NCT00079339/withdraw/3]Withdrawal by Subject [clinicaltrials_resource:NCT00079339/withdraw/4]Disease progression [clinicaltrials_resource:NCT00079339/withdraw/5]
group [clinicaltrials_vocabulary:group]
Tipifarnib 125-mg/m2 [clinicaltrials_resource:NCT00079339/group/P2]
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.
Bio2RDF identifier
NCT00079339/group/P2
Bio2RDF namespace
clinicaltrials_resource
Bio2RDF uri
http://bio2rdf.org/clinicaltrials_resource:NCT00079339/group/P2
group id [clinicaltrials_vocabulary:group-id]
description
Tipifarnib 125 mg/m2 twice a ...... were enrolled to the phase II.
@en
identifier
clinicaltrials_resource:NCT00079339/group/P2
title
Tipifarnib 125-mg/m2
@en
type
label
Tipifarnib 125-mg/m2 [clinicaltrials_resource:NCT00079339/group/P2]
@en