Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Ovarian Cancer Patients |
|
| B | Experimental | Endometrial Cancer Patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MKC-1 | Drug | capsules, provided 125 mg/m2 BID x 14 days in 28 day cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response rate (based on tumor measurements according to the RECIST criteria) or CA-125 | Every 4 to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | Time of progression | |
| Adverse events spontaneously declared by the patients or noted during physical examination and laboratory tests. | As reported |
Not provided
Inclusion Criteria:
Provide written informed consent (and HIPAA authorization for release of protected health information, as applicable) prior to any study related assessments.
Histologically confirmed epithelial ovarian cancer, primary peritoneal carcinomatosis, fallopian tube cancers, or endometrial cancer.
Age > 18 years at the time of consent.
Arm A: Ovarian Cancer Patients:
Arm B: Endometrial Cancer Patients:
ECOG performance status of 0, 1, or 2.
The following laboratory results, within 10 days of MKC-1 administration:
Exclusion Criteria:
Administration of cancer specific therapy within the following periods prior to study drug initiation:
Requirement for paracentesis > 2 liters/week.
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.
Known CNS metastases unless treated, clinically stable, and not requiring steroids.
Clinical evidence of significant bowel obstruction, active uncontrolled malabsorption syndromes, or a history of total gastrectomy.
Uncontrolled hypercalcemia (serum calcium-corrected > 3 mmol/L [12 mg/dL]).
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.
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.
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.
Treatment with antiretroviral therapy metabolized through CYP3A4 (including indinavir, nelfinavir, ritonavir and saquinavir).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amit Oza, MD | Princess Margaret Hospital, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Juravinski Cancer Centre | Hamilton | Ontario | L8V 5C2 | Canada | ||
| Cancer Centre of Southeastern Ontario at Kingston General Hospital |
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Kingston |
| Ontario |
| K7L 5P9 |
| Canada |
| London Health Sciences Centre | London | Ontario | N6A 4L6 | Canada |
| Credit Valley Hospital | Mississauga | Ontario | L5M 2N1 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Hopital Notre-Dame du CHUM | Montreal | Quebec | H2L 4M1 | Canada |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |