Neoplasms
Conditions
Brief summary
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.
Interventions
DRUGRG1530
Administered po at escalating doses (10 cohorts)
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; * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose | Throughout study |
Secondary
| Measure | Time frame |
|---|---|
| AEs, laboratory parameters | Throughout study |
| Plasma levels of R1530 | Throughout study |
| Tumor assessments | Every 2 cycles of treatment |
Countries
United States
Outcome results
None listed