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

This study has been completed.
Sponsor:
Information provided by:
CASI Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00607607
First received: January 23, 2008
Last updated: January 19, 2012
Last verified: January 2012
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by CASI Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Tumor response rate (based on tumor measurements according to the RECIST criteria) or CA-125 [ Time Frame: Every 4 to 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: Time of progression ] [ Designated as safety issue: No ]
  • Adverse events spontaneously declared by the patients or noted during physical examination and laboratory tests. [ Time Frame: As reported ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: January 2008
Study Completion Date: January 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607607

Locations
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 5P9
London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Credit Valley Hospital
Mississauga, Ontario, Canada, L5M 2N1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
CASI Pharmaceuticals, Inc.
Investigators
Principal Investigator: Amit Oza, MD Princess Margaret Hospital, Canada
  More Information

No publications provided

Responsible Party: Carolyn Sidor, MD, MBA, EntreMed, Inc.
ClinicalTrials.gov Identifier: NCT00607607     History of Changes
Other Study ID Numbers: MKC-103
Study First Received: January 23, 2008
Last Updated: January 19, 2012
Health Authority: Canada: Health Canada

Keywords provided by CASI Pharmaceuticals, Inc.:
ovarian cancer
endometrial cancer

Additional relevant MeSH terms:
Endometrial Neoplasms
Ovarian Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on September 22, 2014