A Multiple Ascending Dose Study of R4733 in Patients With Advanced Solid Tumors.
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This study will determine the maximum tolerated dose, safety and pharmacokinetic profile of R4733 (RO4929097), administered orally to patients with refractory metastatic or locally advanced solid tumors. The study will assess three different dosing schedules; in one schedule R4733 will be administered 3days on/ 4 days off, in another on days 1-7 of each 21 day cycle, and in a third schedule continuously daily. 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 100-200 individuals.
Enrollment
Sex
Ages
Volunteers
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 14 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
110 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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