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A Phase 2, Open-Label Study of MAC-321 Administered Intravenously as a Single Agent for the Treatment of Advanced Colorectal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

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Trial Information

A Phase 2, Open-Label Study of MAC-321 Administered Intravenously as a Single Agent for the Treatment of Advanced Colorectal Cancer


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:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Medical Monitor, MD

Investigator Role:

Study Director

Investigator Affiliation:

Wyeth is now a wholly owned subsidiary of Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3128K1-200

NCT ID:

NCT00063427

Start Date:

Completion Date:

February 2004

Related Keywords:

  • Colorectal Neoplasms
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Cancer
  • Colorectal Carcinoma
  • Colorectal Tumors
  • Neoplasms, Colorectal
  • Colorectal Neoplasms
  • Neoplasms
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Rectal Neoplasms

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