Neoplasms
Conditions
Brief summary
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.
Interventions
DRUGRG4733
Administered orally daily at ascending doses to successive cohorts of patients
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>=18 years of age; * advanced and/or metastatic solid tumor malignancy; * measurable or evaluable disease; * ECOG performance status 0 or 1.
Exclusion criteria
* prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug; * prior corticosteroids as anti-cancer therapy within a minimum of 14 days of first receipt of study drug. Dexamethasone may be allowed only as part of the supportive care measures; * major surgery within 28 days of first receipt of study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AEs, laboratory parameters. | Throughout study |
Secondary
| Measure | Time frame |
|---|---|
| Tumor assessments | day 15 cycle 1, at the end of cycle 2 and every 6 weeks thereafter |
| Pharmacokinetic profile | After first dose and last dose (or day 15) of cycles 1 and 2 |
Countries
United States
Outcome results
None listed