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Sponsored by: |
EntreMed |
Information provided by: | EntreMed |
ClinicalTrials.gov Identifier: | NCT00607607 |
Patients will be treated with MKC-1, twice daily for 14 consecutive days every four weeks (a cycle of MKC-1 chemotherapy), until disease progression or unacceptable toxicities. Patients will be stratified to Arm A (ovarian cancer) or Arm B (endometrial cancer), and will receive identical treatment regimens.
Condition | Intervention | Phase |
Ovarian Cancer Endometrial Cancer |
Drug: MKC-1 |
Phase II |
MedlinePlus related topics: | Cancer Ovarian Cancer |
Drug Information available for: | Ro 31-7453 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2 Study of Oral MKC-1 Administered Twice Daily for 14 Consecutive Days Every 4 Weeks in Patients With Recurrent or Resistant Epithelial Ovarian Cancer or Advanced Endometrial Cancer |
Estimated Enrollment: | 80 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Experimental
Ovarian Cancer Patients
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Drug: MKC-1
capsules, provided 125 mg/m2 BID x 14 days in 28 day cycles
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B: Experimental
Endometrial Cancer Patients
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Drug: MKC-1
capsules, provided 125 mg/m2 BID x 14 days in 28 day cycles
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Arm A: Ovarian Cancer Patients:
Arm B: Endometrial Cancer Patients:
The following laboratory results, within 10 days of MKC-1 administration:
Exclusion Criteria:
Administration of cancer specific therapy within the following periods prior to study drug initiation:
Contact: Katrina MacAlpine | 4169464501 ext 4724 | katrina.macalpine@uhn.on.ca |
Contact: Amit Oza, MD | 4169462818 | amit.oza@uhn.on.ca |
Canada, Ontario | |||||
Princess Margaret Hospital | Recruiting | ||||
Toronto, Ontario, Canada, M5G 2M9 | |||||
Contact: Katrina MacAlpine 4169464501 ext 4724 katrina.macalpine@uhn.on.ca | |||||
Contact: Amit Oza, MD 4169462818 amit.oza@uhn.on.ca | |||||
Principal Investigator: Amit Oza, MD | |||||
Juravinski Cancer Centre | Recruiting | ||||
Hamilton, Ontario, Canada, L8V 5C2 | |||||
Principal Investigator: Hal Hirte, MD | |||||
Credit Valley Hospital | Recruiting | ||||
Mississauga, Ontario, Canada, L5M 2N1 | |||||
Principal Investigator: Leonard Kaizer, MD | |||||
London Health Sciences Centre | Recruiting | ||||
London, Ontario, Canada, N6A 4L6 | |||||
Principal Investigator: Stephen Welch, MD | |||||
Cancer Centre of Southeastern Ontario at Kingston General Hospital | Recruiting | ||||
Kingston, Ontario, Canada, K7L 5P9 | |||||
Principal Investigator: Jim Biagi, MD | |||||
Canada, Quebec | |||||
Hopital Notre-Dame du CHUM | Recruiting | ||||
Montreal, Quebec, Canada, H2L 4M1 | |||||
Principal Investigator: Diane Provencher, MD |
EntreMed |
Principal Investigator: | Amit Oza, MD | Princess Margaret Hospital, Canada |
Responsible Party: | EntreMed, Inc. ( Carolyn Sidor, MD, MBA ) |
Study ID Numbers: | MKC-103 |
First Received: | January 23, 2008 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00607607 |
Health Authority: | Canada: Health Canada |
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