A Study of PRO95780 in Combination With Cetuximab and Irinotecan Chemotherapy or the FOLFIRI Regimen With Bevacizumab in Patients With Previously Treated Metastatic Colorectal Cancer (APM4187g)

Sponsor
Genentech, Inc.
Study ID
NCT00497497
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab — DRUG
    (Only for patients not previously treated with bevacizumab) Intravenous repeating dose
  • cetuximab — DRUG
    Intravenous repeating dose
  • FOLFIRI regimen — DRUG
    Intravenous repeating dose
  • irinotecan — DRUG
    Intravenous repeating dose
  • PRO95780 — DRUG
    Intravenous repeating dose

Study Details

This is a Phase Ib, open-label, multicenter, dose-escalation study designed to assess if PRO95780 in combination with two different irinotecan-containing regimens is safe and tolerable in patients with metastatic colorectal cancer (mCRC) who have progressed following, or cannot tolerate, first-line therapy with 5-fluorouracil-, oxaliplatin-, and bevacizumab-containing regimens. This study will also make a preliminary assessment of the anti-tumor activity of PRO95780 in combination with irinotecan and cetuximab or the FOLFIRI regimen plus bevacizumab.

Key Dates

Start date
Oct 31, 2007
Status verified
May 2017
Primary completion
Sep 30, 2010
Completion
Sep 30, 2010

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: 1
  • Experimental: 2

Primary Outcome Measure

Incidence and nature of dose-limiting toxicities [ Time Frame: Through study completion or early study discontinuation ]

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