Dose-Finding Study of E7070 in Combination With Irinotecan

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Eisai Inc.
Study ID
NCT00060567
Phase
PHASE1
Status
Completed

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

E7070 and irinotecan will be administered to patients with GI tract, pancreatic or lung tumors on Days 1 and 8 of a 21-day cycle, or Days 1 and 15 of a 28-day cycle according to one of two E7070 dose escalation schemes.

Key Dates

Start date
Mar 31, 2003
Status verified
Jun 2013
Primary completion
Mar 31, 2013
Completion
Mar 31, 2013

Study Design

Enrollment
88 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: 1
    Active combination of E7070 and irinotecan.
  • Other: 2
    Active combination of E7070 and irinotecan.
  • Other: 3
    Active combination of E7070 and irinotecan.

Primary Outcome Measure

To determine the Maximum tolerated dose of E7070 in combination with irinotecan in patients with GI tract, pancreatic or lung tumors. [ Time Frame: 1st arm: D1, D8, Q3WK; 2nd arm: D1, D8, Q3WK; 3rd arm: D1, D15, Q4WK ]

Locations (1)

FacilityCityStateZIPSite coordinators
-BostonMassachusetts--

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