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Study Evaluating MAC-321 in Colorectal Cancer

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NCT00063427

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00063427
Pfizer
Completed
Study Evaluating MAC-321 in Colorectal Cancer

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Study Evaluating MAC-321 in Colorectal Cancer
A Phase 2, Open-Label Study of MAC-321 Administered Intravenously as a Single Agent for the Treatment of Advanced Colorectal Cancer
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
  • Colorectal Neoplasms
  • Colonic Neoplasms
  • Rectal Neoplasms
Drug: MAC-321
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
February 2004
February 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00063427
3128K1-200
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
August 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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