Multiple Ascending Dose (MAD) Study of R4733 Administered Orally in Patients With Refractory Metastatic or Locally Advanced Solid Tumors
- adult patients, >=18 years of age;
- advanced and/or metastatic solid tumor malignancy;
- measurable or evaluable disease;
- ECOG performance status 0 or 1.
- prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of
- 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
- major surgery within 28 days of first receipt of study drug.
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
AEs, laboratory parameters.
Outcome Time Frame:
United States: Food and Drug Administration
||Austin, Texas 78705
||Hackensack, New Jersey 07601