A Multiple Ascending Dose Study of R1530 in Patients With Advanced Solid Tumors.
Completed · Phase 1
Conditions studied: Neoplasms
In brief
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.
Key facts
- Study ID
- NCT00493155
- Run by
- Hoffmann-La Roche
- People needed
- 48
- Starts
- 2005-10-01
- Expected to finish
- 2009-02-01
- Last updated by the study team
- 2016-11-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Study site — Boston, Massachusetts, United States
- Study site — Boston, Massachusetts, United States
- Study site — Boston, Massachusetts, United States
- Study site — Detroit, Michigan, United States
- Study site — Las Vegas, Nevada, United States
- Study site — Houston, Texas, United States
Full record on ClinicalTrials.gov
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