Phase 2 Study Of Oral MKC-1 In Patients With Unresectable Or Metastatic Pancreatic Cancer

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-12-04	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2011-08-03
First Submitted that Met QC Criteria 2007-12-04	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2011-08-04
First Posted (ESTIMATED) 2007-12-06	Results First Posted N/A	Last Verified 2011-08

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 1	DRUG: MKC-1 Oral MKC-1 capsules, administered twice daily, for 14 consecutive days, in a 28-day cycles

Participant Group/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	Measure Description	Time Frame
Objective tumor response rate based on tumor measurements according to the RECIST		every 8 weeks

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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:

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.

Collaborators and Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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Resources

PatientS

Caregivers

Clinical Trial Record