Solid Tumors Clinical Trial
Official title:
Evaluation of an Alternative Schedule for CRLX101 Alone in Combination With Bevacizumab and in Combination With mFOLFOX6 in Subjects With Advanced Solid Tumor Malignancies
The purpose of this study is to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of weekly dosing of CRLX101 (both as monotherapy; (Schedule 1) and in combination with bevacizumab every 2 weeks (Schedule 2) and weekly with a 3 week on / 1 week off schedule in combination with mFOLFOX6 (Schedule 3) to affirm the dose for future clinical studies.
This is an open-label, dose escalation study. Subjects enrolled in Schedule 1 will receive
weekly CRLX101 alone. The starting dose for Schedule 1 is 12 mg/m^2 and the next dose level
is 15 mg/m^2 (or 10 mg/m^2 if 12 mg/m^2 is not well tolerated). No other dose levels in
Schedule 1 will be explored.
Subjects enrolled in Schedule 2 will receive weekly CRLX101 in combination with bi-weekly
bevacizumab (10 mg/kg) The starting dose for Schedule 2 is 12 mg/m^ and the next dose is 15
mg/m^2. No other dose levels in Schedule 2 will be explored
Subjects enrolled in Schedule 3 will receive weekly CRLX101 for 3 of every 4 weeks in
combination with bi-weekly mFOLFOX6 (oxaliplatin 85 mg/m^2, leucovorin 400 mg/m^2 and 5FU
(fluorouracil) 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous infusion). The starting
dose for Schedule 3 is 12 mg/m^2 and the next dose is 15 mg/m^2.
In the absence of dose-limiting toxicities (DLTs) additional subjects may be enrolled
(expansion cohort) at the same, intermediate or lower dose levels following consultation
between the Investigator and Sponsor.
Enrollment of 6-8 subjects will occur in each cohort for all 3 Schedules.
The MTD is defined as the highest dose level at which fewer than 2 out of 6 subjects
experience a DLT. RP2D will be selected based on overall tolerability data from all subjects
treated at different dose cohorts in this study.
No intra-patient dose escalation is allowed.
Approximately 61 evaluable subjects are anticipated to be enrolled: 15 subjects in Schedule
1, 15 subjects in Schedule 2 and approximately 31 subjects are anticipated in Schedule 3
(approximately 16 in the dose escalation cohort and up to 15 in the expansion cohort).
The exact number of subjects is dependent on the actual number of subjects enrolled per
cohort and the number of cohorts investigated.
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