Adult Solid Neoplasm Clinical Trial
Official title:
Randomized Drug Interaction Study of RO4929097 for Advanced Solid Tumors
This randomized phase I trial studies the side effects and best dose of RO4929097 in treating patients with advanced solid tumors. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To evaluate the extent that RO4929097 induces its own metabolism using a 20mg dose on
Regimen I and a 50mg dose on Regimen II by comparing Cycle 1 Day 1 and Day 10 plasma
pharmacokinetic parameters.
SECONDARY OBJECTIVES:
I. To evaluate the effect of the strong inhibitor of CYP3A4, ketoconazole, on RO4929097
plasma pharmacokinetics.
II. To evaluate the effect of the strong inducer of CYP3A4, 2D6 and 2C9, rifampin on
RO4929097 plasma pharmacokinetics.
III. To evaluate the effect of RO4929097 on the plasma pharmacokinetics of CYP450
substrates; midazolam (CYP3A4), omeprazole (CYP2C19), tolbutamide (CYP2C9) and
dextromethorphan (CYP2D6) after single dose and chronic administration.
IV. To assess the influence of polymorphisms in CYP3A4, 3A5, 2C9, ABCB1, and 2D6 on
RO4929097 plasma pharmacokinetics V. To assess any evidence of clinical activity (CR, PR,
SD) in patients with advanced solid tumors.
OUTLINE: Patients are randomized to 1 of 2 treatment regimens.
Regimen I (low-dose of RO4929097): Patients receive low-dose RO4929097 orally (PO) once
daily on days 1-3, 8-10, and 15-17 and midazolam hydrochloride IV over 1 minute, omeprazole
PO, tolbutamide PO, and dextromethorphan hydrobromide PO on days 1 and 10. After completion
of course 1, patients are randomized to 1 of 2 treatment arms.
Arm A: Patients receive low-dose RO4929097 PO once daily on days 1-3, 8-10, and 15-17 and
ketoconazole PO once daily on days 1-10 for course 2 only. For course 3 and beyond, patients
receive low-dose RO4929097 on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.
Arm B: Patients receive low-dose RO4929097 PO once daily on days 1-3, 8-10, and 15-17 and
rifampin PO once daily on days 1-10 for course 2 only. For course 3 and beyond, patients
receive low-dose RO4929097 on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.
Regimen II (high-dose of RO4929097): Patients receive high-dose RO4929097 PO once daily on
days 1-3, 8-10, and 15-17 and midazolam hydrochloride IV, oral omeprazole, oral tolbutamide,
and oral dextromethorphan hydrobromide on days 1 and 10. After completion of course 1,
patients are randomized to 1 of 2 treatment arms.
Arm A: Patients receive high-dose RO4929097 once daily on days 1-3, 8-10, and 15-17 and oral
ketoconazole once daily on days 1-10 for course 2 only.
Arm B: Patients receive high-dose RO4929097 once daily on days 1-3, 8-10, and 15-17 and oral
rifampin once daily on days 1-10 for course 2 only.
In all arms, treatment with RO4929097 repeats every 21 days for >= 3 courses in the absence
of disease progression or unacceptable toxicity.
Patients undergo blood sample collection at baseline and periodically during study for
pharmacokinetics studies and evaluation of SNPs in CYP2D6, CYP2C9, ABCB1, and CYP3A4/5.
After completion of study therapy, patients are followed up for 30 days.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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