Study of REOLYSIN® in Combination With FOLFIRI and Bevacizumab in FOLFIRI Naive Patients With KRAS Mutant Metastatic Colorectal Cancer

Conditions

• KRAS Mutant Metastatic Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• REOLYSIN® — BIOLOGICAL
  1 hour intravenous infusion administered on Days 1, 2, 3, 4, and 5 every 4 weeks.
• Irinotecan — DRUG
  90-minute intravenous infusion on Day 1 every 2 weeks. Dose levels of 125 mg/m2, 150 mg/m2, 150 mg/m2, 180 mg/m2.
• Leucovorin — DRUG
  2-hour infusion of 400 mg/m2 on Day 1 every 2 weeks.
• Fluorouracil (5-FU) — DRUG
  400 mg/m2 intravenous bolus followed by 2400 mg/m2 as a continuous intravenous infusion over 46 hours administered on Day 1 every 2 weeks.
• Bevacizumab — DRUG
  30, 60 or 90 minute infusion on Day 1 every 2 weeks. Dose level 5 mg/kg.

Study Details

This is a Phase 1 dose-escalation study with three dose levels to determine the maximum tolerated dose of REOLYSIN® combined with FOLFIRI and bevacizumab.

Key Dates

Start date

Dec 31, 2010

Status verified

Dec 2018

Primary completion

Feb 28, 2018

Completion

Nov 30, 2018

Study Design

Enrollment

36 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Primary Outcome Measure

Dose limiting toxicity to define maximum tolerated dose and recommended Phase 2 dose [ Time Frame: During the first cycle of treatment (4 week cycle) ]

Locations (2)

Find similar trials in New York, NY

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