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Phase 2 Study of Oral MKC-1 in Patients With Unresectable or Metastatic Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00568646
Recruitment Status : Completed
First Posted : December 6, 2007
Last Update Posted : August 4, 2011
Information provided by:
CASI Pharmaceuticals, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Pancreatic Cancer Drug: MKC-1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2007
Primary Completion Date : April 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: MKC-1
Oral MKC-1 capsules, administered twice daily, for 14 consecutive days, in a 28-day cycles

Primary Outcome Measures :
  1. Objective tumor response rate based on tumor measurements according to the RECIST [ Time Frame: every 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Provide written informed consent and Health Insurance Portability and Accountability Act authorization for release of protected health information before any study related assessments
  • Have histologically confirmed pancreatic cancer and measurable disease according to RECIST
  • Have failed at least one prior chemotherapy regimen in either the neoadjuvant, adjuvant, or first-line metastatic setting
  • Be at least 18 years of age at the time of consent
  • Have an Eastern Cooperative Oncology Group performance status of 0 or 1
  • Have the following laboratory results, within 10 days before the first MKC 1 administration:

    1. Hemoglobin greater than or equal to 9 g/dL
    2. Absolute neutrophil count greater than or equal to 1.5 x 109 cells/L
    3. Platelet count greater than or equal to 75 x 109 cells/L
    4. Serum creatinine less than or equal to 1.5 times the upper limit of normal (ULN)
    5. Aspartate transaminase less than or equal to 2.5 times the ULN
    6. Serum albumin greater than or equal to 3.0 g/dL
    7. Total bilirubin less than or equal to the ULN

Exclusion Criteria:

  • Be a pregnant or breast-feeding woman. Female patients must be postmenopausal, surgically sterile, or they must agree to use a barrier method of contraception. Female patients of childbearing potential must have a negative pregnancy test within the 10 days before the first MKC 1 administration. Male patients must be surgically sterile or agree to use an acceptable method of contraception.
  • Have known central nervous system metastases unless they are being treated, are clinically stable, and do not require the use of steroids.
  • Have clinical evidence of significant bowel obstruction, active uncontrolled malabsorption syndromes, or a history of total gastrectomy.
  • Have uncontrolled hypercalcemia (serum calcium-corrected greater than 12 mg/dL).
  • Have a serious cardiac condition (Class III/IV congestive heart failure according to New York Heart Association classification) or documented acute myocardial infarction within the previous 6 months.
  • Have any medical conditions that, in the investigator's opinion, would impose excessive risk to the patient. These conditions include: infection requiring parenteral or oral anti-infective treatment or any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent.
  • Have had previous malignancies, unless free of recurrence for at least 5 years except cured basal cell carcinoma of the skin or carcinoma-in-situ of the uterine cervix.
  • Be receiving treatment with antiretroviral therapy metabolized through CYP3A4 (including indinavir, nelfinavir, ritonavir, and saquinavir, or any other medications that interfere with CYP3A4).
  • Have, in the opinion of the investigator, any clinically significant existing toxicities from previous chemotherapy therapies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00568646

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
CASI Pharmaceuticals, Inc.
Principal Investigator: Eunice Kwak, MD, PhD Massachusetts General Hospital

Responsible Party: Carolyn Sidor, Miikana Therapeutics, an EntreMed, Inc. Company
ClinicalTrials.gov Identifier: NCT00568646     History of Changes
Other Study ID Numbers: MKC-105
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: August 4, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases