A Multiple Ascending Dose Study of R1530 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: | October 2005 |
| End Date: | February 2009 |
"An Open-label, Multiple Ascending Dose Study to Determine the Maximum Tolerated Dose of R1530 in Patients With Advanced Solid Tumors."
This study will determine the maximum tolerated dose, and assess the safety, tolerability
and pharmacokinetics of R1530 administered orally to patients with advanced or metastatic
solid tumors. R1530 will be administered daily for 14 days at the starting dose; this dose
will be escalated in subsequent cohorts of patients, after a satisfactory assessment of
safety and tolerability of the previous dose, until the maximum tolerated dose is reached.
The anticipated time on study treatment is until disease progression, and the target sample
size is <100 individuals.
and pharmacokinetics of R1530 administered orally to patients with advanced or metastatic
solid tumors. R1530 will be administered daily for 14 days at the starting dose; this dose
will be escalated in subsequent cohorts of patients, after a satisfactory assessment of
safety and tolerability of the previous dose, until the maximum tolerated dose is reached.
The anticipated time on study treatment is until disease progression, and the target sample
size is <100 individuals.
Inclusion Criteria:
- adult patients, >=18 years of age;
- cancer not amenable to curative treatment (ie advanced and/or metastatic);
- measurable or evaluable disease;
- adequate cardiac, hepatic and renal function.
Exclusion Criteria:
- patients with known CNS metastases;
- serious cardiovascular illness or other medical conditions;
- prior chemotherapy, radiotherapy or immunotherapy within 28 days of start of
treatment , or hormone therapy within 14 days of start of treatment;
- inability to swallow oral medications, or impaired gastrointestinal absorption.
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