Study Evaluating MAC-321 in Colorectal Cancer

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

MAC-321

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Neoplasms, Colorectal, Colorectal Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00063427

First Posted

June 26, 2003

Last Updated

August 20, 2009

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00063427

Brief Title

Study Evaluating MAC-321 in Colorectal Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

February 2004 (Actual)

Study Completion Date

February 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

Keywords

Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Neoplasms, Colorectal, Colorectal Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

MAC-321

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor, MD

Organizational Affiliation

Wyeth is now a wholly owned subsidiary of Pfizer

Official's Role

Study Director

Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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