Trial information
A Multiple Ascending Dose Study of R4733 in Patients With Advanced Solid Tumors.
Status: Recruiting
Protocol number: NO21321
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: Multiple Ascending Dose (MAD) Study of R4733 Administered Orally in Patients with Refractory Metastatic or Locally Advanced Solid Tumors
Brief summary: This study will determine the maximum tolerated dose, safety and pharmacokinetic profile of R4733, administered orally to patients with refractory metastatic or locally advanced solid tumors. The study will assess two different dosing schedules; in one schedule R4733 will be administered on days 1, 2, 3, 8, 9, and 10 of each 21 day cycle, and in the other on days 1-7 of each 21 day cycle. The starting dose for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of the safety and tolerability of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is <100 individuals. Target sample size is
96.
Study phase: I
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
Condition: Neoplasms
Intervention type: Drug
Intervention name: R4733
Primary outcome: 1. AEs, laboratory parameters. Time frame: Throughout study
Key secondary outcomes: 1. Tumor assessments Time frame: Every 6 weeks
2. Pharmacokinetic profile Time frame: After first dose, last dose of cycle 1, and first dose of cycle 2.
Inclusion criteria:
- adult patients, >=18 years of age;
- advanced and/or metastatic solid tumor malignancy;
- measurable or evaluable disease;
- ECOG performance status 0 or 1.
Exclusion criteria:
- prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug;
- prior corticosteroids as anti-cancer therapy within a minimum of 7 days of first receipt of study drug. Dexamethasone may be allowed only as part of the supportive care measures;
- major surgery within 28 days of first receipt of study drug.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: November, 2007
Trial registration date: 09/17/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
United States
- Aurora, CO
- Boston, MA
- New Brunswick, NJ
- Houston, TX
- San Antonio, TX
