CClinicalTrials.gg
CompletedNCT00063427Updated Aug 21, 2009

Study Evaluating MAC-321 in Colorectal Cancer

A Phase 2 interventional study of MAC-321 in Colorectal Neoplasms, Colonic Neoplasms and Rectal Neoplasms, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-08-21.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
45
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Assess the clinical activity of MAC-321 administered IV as a second-line or third-line antineoplastic agent to subjects with advanced colorectal cancer. Clinical activity will be assessed by determining the percentage of subjects exhibiting an objective response (complete plus partial responses). Tumor response will be assessed following modified Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.

02

Conditions studied

  • Colorectal Neoplasms
  • Colonic Neoplasms
  • Rectal Neoplasms

Keywords

  • Colorectal Cancer
  • Colorectal Carcinoma
  • Colorectal Tumors
  • Neoplasms, Colorectal
  • Colorectal Neoplasms
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 45 is close to the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

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

  • Histologic and/or cytologic diagnosis of metastatic or relapsed colorectal cancer at any time during disease but not candidates for surgical resection.
  • Prior treatment with at least 1 conventional approved therapeutic regimen.
  • Subjects who have failed prior cytotoxic chemotherapy regimens containing irinotecan (CPT-11), 5 fluorouracil (5-FU), and/or oxaliplatin for advanced (relapsed) metastatic colon cancer are eligible

Exclusion criteria

Exclusion Criteria:

  • Other chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks before signing the ICF (6 weeks if the previous chemotherapy included nitrosoureas or mitomycin)
  • Prior radiotherapy to >25% of bone marrow
  • Prior exposure to MAC-321
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Masking
None (open label)
Enrollment
45 participants (actual)

Interventions

  • DrugMAC-321
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00063427
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
First posted
Jun 27, 2003
Primary completion
Feb 2004
Completion
Feb 2004
Last update
Aug 21, 2009

Study contacts

Medical Monitor, MD
study director · Wyeth is now a wholly owned subsidiary of Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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