Phase II Study to Evaluate G17DT in Combination With Irinotecan in Patients With Colorectal Carcinoma

Sponsor
Cancer Advances Inc.
Study ID
NCT02118064
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • G17DT-Irinotecan — BIOLOGICAL
    500µg dose of G17DT intramuscular injection in combination with 125 mg/m\^2 intravenous infusion of Irinotecan over 90 minutes.

Study Details

This study was designed to evaluate the ability for G17DT to slow or arrest tumor growth in patients with refractory colon cancer who had been previously treated with an Irinotecan-based chemotherapy.

Key Dates

Start date
Mar 31, 2001
Status verified
Jan 2014
Primary completion
Dec 31, 2002

Study Design

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

Arms

  • Experimental: G17DT-Irinotecan
    500µg dose of G17DT intramuscular injection in combination with 125 mg/m\^2 intravenous infusion of Irinotecan over 90 minutes.

Primary Outcome Measure

Tumor response [ Time Frame: up to 12 months ]

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