Trial information
A Multiple Ascending Dose Study of R1530 in Patients With Advanced Solid Tumors.
Status: Recruiting
Protocol number: NO18674
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: "An open-label, multiple ascending dose study to determine the maximum tolerated dose of R1530 in patients with advanced solid tumors."
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. Target sample size is 70.
Study phase: I
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Neoplasms
Intervention type: Drug
Intervention name: R1530
Primary outcome: 1. Maximum tolerated dose Time frame: Throughout study
Key secondary outcomes: 1. AEs, laboratory parameters Time frame: Throughout study
2. Plasma levels of R1530 Time frame: Throughout study
3. Tumor assessments Time frame: Every 2 cycles of treatment
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: October, 2005
Trial registration date: 06/27/2007
Date last updated: 10/15/2008
Link to trial result
This trial is being conducted at the following locations:
United States
- Boston, MA
- Detroit, MI
- Las Vegas, NV
- Houston, TX
