A Study of R547 in Patients With Advanced Solid Tumors.
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/3/2016 |
| Start Date: | May 2005 |
| End Date: | November 2008 |
A Multiple Ascending Dose (MAD) Study of R547 Administered as an Intravenous Infusion on a Weekly Schedule in Patients With Advanced Solid Tumors
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.
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.
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.
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