Neoplasms
Conditions
Brief summary
This single arm study will determine the maximum tolerated dose, and recommended dose for further development, of R547, in patients with advanced solid tumors. Groups of patients will receive ascending doses of R547 as weekly intravenous infusions administered over a) 90 minutes and b) 180 minutes, on days 1 and 8 of a 21 day cycle. In the absence of dose-limiting toxicity following the starting dose, incremental dose-escalations will be allowed in subsequent cohorts of patients until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is \<100 individuals.
Interventions
DRUGRG547
Administered iv on days 1 and 8 of a 3 week cycle at escalating doses to successive groups of patients until MTD is reached.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
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; * locally advanced or metastatic solid tumors; * measurable or evaluable disease.
Exclusion criteria
* prior chemotherapy, radiotherapy or immunotherapy within 3 weeks of start of study; * prior history of CNS metastases with disease progression; * patients taking strong inhibitors and/or inducers of CYP3A4.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AEs, laboratory parameters. | Throughout study |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic and pharmacodynamic profiles of R547 | Throughout study |
Countries
United States
Outcome results
None listed