Neoplasms
Conditions
Brief summary
This study will determine the maximum tolerated dose and the optimal associated 4 weekly dosing schedule of RO5045337, administered as monotherapy in patients with advanced solid tumors. A first cohort of patients will receive the starting dose of 20mg/m2/day, once daily for 10 days in each 28 day cycle. Subsequent cohorts of patients will receive dose escalations, and possible changes in dosing schedule, based on tolerability and pharmacokinetic knowledge gained from prior treatment cohorts. The anticipated time on study treatment is until disease progression or intolerable toxicity.
Interventions
DRUGRO5045337
Administered po at escalating doses (with a starting dose of 20mg/m2/day) (5-10 cohorts)
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; * solid tumor malignancies; * failed prior therapies, or no standard therapy available; * ECOG performance status of 0-2.
Exclusion criteria
* patients receiving any other agent or therapy to treat their malignancy; * pre-existing gastrointestinal disorders which may interfere with absorption of drugs; * clinically significant cardiovascular disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD and associated dose schedule | Every 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response | Event driven |
| Dose-limiting toxicities. | Throughout study |
| Pharmacokinetic profile | Throughout study |
| Comparison safety and tolerability of daily versus twice daily dosing regimens | approximately 18 months |
Countries
France, United States
Outcome results
None listed