A Phase 1 interventional study of RG4733 and RG4733 in Neoplasms, sponsored by Hoffmann-La Roche. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment
This study will determine the maximum tolerated dose, safety and pharmacokinetic profile of R4733 (RO4929097), administered orally to patients with refractory metastatic or locally advanced solid tumors. The study will assess three different dosing schedules; in one schedule R4733 will be administered 3days on/ 4 days off, in another on days 1-7 of each 21 day cycle, and in a third schedule continuously daily. The starting dose for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of the safety and tolerability of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is 100-200 individuals.
Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: RG4733
Drug: RG4733
Drug: RG4733
Administered orally daily at ascending doses to successive cohorts of patients
Also known as: RO4929097
Administered orally at ascending doses to successive cohorts of patients, on a 3 days on/ 4 days off schedule
Also known as: RO4929097
Administered orally at ascending doses to successive cohorts of patients, on days 1-7 of each 21 day cycle
Also known as: RO4929097
AEs, laboratory parameters.
Time frame: Throughout study
Tumor assessments
Time frame: day 15 cycle 1, at the end of cycle 2 and every 6 weeks thereafter
Pharmacokinetic profile
Time frame: After first dose and last dose (or day 15) of cycles 1 and 2
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche