CClinicalTrials.gg
TerminatedNCT00065117Updated Jan 26, 2011

Safety, Tolerability and Efficacy of ZD6126 in Combination With Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects With Metastatic Colorectal Cancer.

A Phase 2 interventional study of ZD6126 and Placebo in Colorectal Neoplasms and Metastases, Neoplasm, sponsored by AstraZeneca. Terminated at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-01-26.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to assess the Safety, Tolerability and Efficacy of ZD6126 in Combination with Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects with Metastatic Colorectal Cancer.

02

Conditions studied

  • Colorectal Neoplasms
  • Metastases, Neoplasm

Keywords

  • metastatic
  • colorectal
  • first-line
  • adjuvant
  • cancer
  • Colorectal Cancer
  • Colorectal Carcinoma
  • Colorectal Tumors
  • Neoplasms, Colorectal
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 180 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Metastatic colorectal carcinoma
  • Suitable for first-line treatment of metastatic disease

Exclusion criteria

Exclusion Criteria:

  • Peripheral neuropathy greater than Grade 1
  • Adjuvant therapy within 6 months prior to study treatment
  • Prior oxaliplatin
  • Prior pelvic or whole abdomen radiation
  • Any history of coronary angioplasty or history of myocardial infarction
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
180 participants

Interventions

  • DrugZD6126
  • DrugPlacebo
  • Drug5-fluorouracil
  • Drugleucovorin
  • Drugoxaliplatin
06

Study locations

10 sites
  • Research Site
    Los Angeles, California, United States
  • Research Site
    San Francisco, California, United States
  • Research Site
    Chicago, Illinois, United States
  • Research Site
    New Orleans, Louisiana, United States
  • Research Site
    Baltimore, Maryland, United States
  • Research Site
    St. Louis, Missouri, United States
  • Research Site
    New York, New York, United States
  • Research Site
    Chapel Hill, North Carolina, United States
  • Research Site
    Durham, North Carolina, United States
  • Research Site
    Pittsburgh, Pennsylvania, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00065117
Lead sponsor
AstraZeneca
First posted
Jul 18, 2003
Start date
Sep 2003
Primary completion
Feb 2004
Completion
Feb 2004
Last update
Jan 26, 2011
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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