Clinical Trial: A Study of RO5045337 [RG7112] in Patients With Hematologic Neoplasms.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open Label Study to Investigate the Maximum Tolerated Dose of RO5045337 in Patients With Acute Myelogenous Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Chronic Myelogenous Leukemia (CML) in Bl

Brief Summary: This study will determine the maximum tolerated dose of RO5045337 and the optimal associated 4 weekly dosing schedule of RO5045337, administered as monotherapy in patients with hematologic neoplasms. A first cohort of patients will receive the starting dose of 20mg/m2/day orally, once daily for 10 days in each 28 day cycle. Subsequent cohorts of patients will receive dose escalations, and possible changes in dosing schedule, based on tolerability and pharmacokinetic knowledge gained from prior treatment cohorts. Different formulations of RO5045337 will be tested and the food effect evaluated. The anticipated time on study treatment is until disease progression or intolerable toxicity.

Detailed Summary:
Sponsor: Hoffmann-La Roche

Current Primary Outcome:

  • Maximum tolerated dose/Dose-limiting toxicities [ Time Frame: approximately 4.5 years ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 4.5 years ]
  • Comparison of daily versus twice daily dosing: Incidence of adverse events [ Time Frame: approximately 4.5 years ]


Original Primary Outcome: Maximum tolerated dose and associated dose schedule [ Time Frame: Throughout study ]

Current Secondary Outcome:

  • Pharmacokinetics: Blood/Urine concentrations [ Time Frame: Pre- and post-dose multiple sampling Days 1+2/Days 1+10 Cycle 1, post-dose sampling Days 11+15 Cycle 1, pre-dose Days 1+2 Cycle 2 ]
  • Pharmacodynamics: Blood leukemia cells/MIC-1 protein level/CD33+CD34 markers [ Time Frame: Pre- and post-dose Days 1+10 Cycle 1, pre-dose Day 2 Cycle 1, Days 1+2 Cycle 2 ]
  • Clinical response: Clinical/hematologic malignancy assessments [ Time Frame: approximately 4.5 years ]


Original Secondary Outcome: Clinical response. Dose limiting toxicities. Pharmacokinetic profile. [ Time Frame: Throughout study ]

Information By: Hoffmann-La Roche

Dates:
Date Received: February 18, 2008
Date Started: May 2008
Date Completion:
Last Updated: November 1, 2016
Last Verified: November 2016