ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Phase 2 Study of Oral MKC-1 in Patients With Ovarian or Endometrial Cancer

This study is currently recruiting participants.
Verified by EntreMed, July 2008

Sponsored by: EntreMed
Information provided by: EntreMed
ClinicalTrials.gov Identifier: NCT00607607
  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 II

MedlinePlus related topics:   Cancer    Ovarian Cancer   

Drug Information available for:   Ro 31-7453   

U.S. FDA Resources

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

Further study details as provided by EntreMed:

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 ]

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
Drug: MKC-1
capsules, provided 125 mg/m2 BID x 14 days in 28 day cycles
B: Experimental
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

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

Contacts
Contact: Katrina MacAlpine     4169464501 ext 4724     katrina.macalpine@uhn.on.ca    
Contact: Amit Oza, MD     4169462818     amit.oza@uhn.on.ca    

Locations
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            

Sponsors and Collaborators
EntreMed

Investigators
Principal Investigator:     Amit Oza, MD     Princess Margaret Hospital, Canada    
  More Information


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

Keywords provided by EntreMed:
ovarian cancer  
endometrial cancer  

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Uterine Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Recurrence
Genital Diseases, Female
Endometrial Neoplasms
Uterine Neoplasms
Endocrinopathy
Endometrial cancer
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on November 06, 2008




Links to all studies - primarily for crawlers