A Phase 2 Study of Oral MKC-1 in Patients With Ovarian or Endometrial Cancer

January 19, 2012 updated by: CASI pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre
      • Kingston, Ontario, Canada, K7L 5P9
        • Cancer Centre of Southeastern Ontario at Kingston General Hospital
      • London, Ontario, Canada, N6A 4L6
        • London Health Sciences Centre
      • Mississauga, Ontario, Canada, L5M 2N1
        • Credit Valley Hospital
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Hopital Notre-Dame du CHUM

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Provide written informed consent (and HIPAA authorization for release of protected health information, as applicable) prior to any study related assessments.
  2. Histologically confirmed epithelial ovarian cancer, primary peritoneal carcinomatosis, fallopian tube cancers, or endometrial cancer.
  3. Age > 18 years at the time of consent.

  4. Arm A: Ovarian Cancer Patients:

    • Must have failed at least one prior platinum based and one taxane based chemotherapeutic regimen. [Platinum failure is defined as platinum-refractory (progression while receiving a platinum-containing regimen) or platinum-resistant (disease progression within 6 months from completion of platinum containing regimen)].
    • Have measurable disease according to RECIST or CA 125 criteria according to GCIG (CA-125 value of > 2 xULN).
    • Have no more than 3 prior regimens for their disease.

    Arm B: Endometrial Cancer Patients:

    • Have no more than 3 prior regimens for their disease
    • Have measurable disease according to RECIST.
  5. ECOG performance status of 0, 1, or 2.

  6. The following laboratory results, within 10 days of MKC-1 administration:

    • Hemoglobin greater than or equal to 90 g/L (9 g/dL)
    • Absolute neutrophil count greater than or equal to 1.5 x 109/L
    • Platelet count greater than or equal to 100 x 109/L
    • Serum creatinine less than or equal to 1.5 x ULN (upper limit of normal)
    • AST less than or equal to 2.5 x ULN
    • Serum Albumin greater than or equal to 30 g/L (3.0 g/dL)
    • Total bilirubin less than or equal to ULN

Exclusion Criteria:

  1. Administration of cancer specific therapy within the following periods prior to study drug initiation:

    • chemotherapy less than 3 weeks prior;
    • hormonal therapy less than one week prior;
    • radiation therapy less than 2 weeks prior.
  2. Requirement for paracentesis > 2 liters/week.
  3. Pregnant or breast-feeding women. Female patients must be postmenopausal, surgically sterile, or they must agree to use a physical method of contraception. Female patient with childbearing potential must have a negative pregnancy test within 10 days before the first MKC-1 administration.
  4. Known CNS metastases unless treated, clinically stable, and not requiring steroids.
  5. Clinical evidence of significant bowel obstruction, active uncontrolled malabsorption syndromes, or a history of total gastrectomy.
  6. Uncontrolled hypercalcemia (serum calcium-corrected > 3 mmol/L [12 mg/dL]).
  7. Serious cardiac condition (Class III/IV congestive heart failure according to New York Heart Association classification); documented acute myocardial infarction within the previous 6 months.
  8. Any medical conditions that, in the investigator's opinion, would impose excessive risk to the patient. These include: infection requiring parenteral or oral anti-infective treatment, any altered mental status, or any psychiatric condition that would interfere with the understanding of the informed consent.
  9. Patients with 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.
  10. Treatment with antiretroviral therapy metabolized through CYP3A4 (including indinavir, nelfinavir, ritonavir and saquinavir).

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Ovarian Cancer Patients
Drug: MKC-1
capsules, provided 125 mg/m2 BID x 14 days in 28 day cycles
Experimental: B
Endometrial Cancer Patients
Drug: MKC-1
capsules, provided 125 mg/m2 BID x 14 days in 28 day cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor response rate (based on tumor measurements according to the RECIST criteria) or CA-125
Time Frame: Every 4 to 8 weeks
Every 4 to 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to progression
Time Frame: Time of progression
Time of progression
Adverse events spontaneously declared by the patients or noted during physical examination and laboratory tests.
Time Frame: As reported
As reported

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CASI pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Amit Oza, MD, Princess Margaret Hospital, Canada

Study record dates

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 Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

January 23, 2008

First Submitted That Met QC Criteria

January 23, 2008

First Posted (Estimate)

February 6, 2008

Study Record Updates

Last Update Posted (Estimate)

January 20, 2012

Last Update Submitted That Met QC Criteria

January 19, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MKC-103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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