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Sponsored by: |
EntreMed |
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Information provided by: | EntreMed |
ClinicalTrials.gov Identifier: | NCT00568646 |
To determine the antitumor activity of MKC-1 in patients with unresectable or metastatic pancreatic cancer who have failed at least one prior chemotherapy regimen in either the neoadjuvant, adjuvant, or first-line metastatic setting
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: MKC-1 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | A Phase 2 Study of Oral MKC 1, Administered Twice Daily for 14 Consecutive Days in a 28-Day Cycle, in Patients With Unresectable or Metastatic Pancreatic Cancer Who Have Failed at Least One Prior Chemotherapy Regimen in Either the Neoadjuvant, Adjuvant, or First-Line Metastatic Setting |
Estimated Enrollment: | 33 |
Study Start Date: | November 2007 |
Study Completion Date: | May 2009 |
Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: MKC-1
Oral MKC-1 capsules, administered twice daily, for 14 consecutive days, in a 28-day cycles
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Have the following laboratory results, within 10 days before the first MKC 1 administration:
Exclusion Criteria:
Male patients must be surgically sterile or agree to use an acceptable method of contraception.
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Eunice Kwak, MD, PhD | Massachusetts General Hospital |
Responsible Party: | Miikana Therapeutics, an EntreMed, Inc. Company ( Carolyn Sidor ) |
Study ID Numbers: | MKC-105 |
Study First Received: | December 4, 2007 |
Last Updated: | May 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00568646 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Adjuvants, Immunologic Endocrine System Diseases |
Pancreatic Diseases Gastrointestinal Neoplasms Endocrinopathy Endocrine Gland Neoplasms |
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms |
Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases Endocrine Gland Neoplasms |