Study Evaluating MAC-321 in Colorectal Cancer - Full Text View

Study Evaluating MAC-321 in Colorectal Cancer

This study is ongoing, but not recruiting participants.

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00063427

Purpose

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.

Condition	Intervention	Phase
Colorectal Neoplasms Colonic Neoplasms Rectal Neoplasms	Drug: MAC-321	Phase II

MedlinePlus related topics:

Cancer Colorectal Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label

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

Further study details as provided by Wyeth:

Estimated Enrollment:

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063427

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor, MD	Wyeth

More Information

Study ID Numbers:	3128K1-200
First Received:	June 26, 2003
Last Updated:	May 18, 2006
ClinicalTrials.gov Identifier:	NCT00063427
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Colorectal Cancer

Colorectal Carcinoma

Colorectal Tumors

Neoplasms, Colorectal

Colorectal Neoplasms

Study placed in the following topic categories:

Digestive System Neoplasms

Rectal Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Intestinal Neoplasms

Carcinoma

Rectal neoplasm

Digestive System Diseases

Gastrointestinal Neoplasms

Colonic Neoplasms

Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on October 14, 2008