Status:
COMPLETED
A Phase 2 Study of Oral MKC-1 in Patients With Ovarian or Endometrial Cancer
Lead Sponsor:
CASI Pharmaceuticals, Inc.
Conditions:
Ovarian Cancer
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 strati...
Eligibility Criteria
Inclusion
- 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:
- 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.
- ECOG performance status of 0, 1, or 2.
- 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
- 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.
- 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).
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00607607
Start Date
January 1 2008
End Date
January 1 2012
Last Update
January 20 2012
Active Locations (6)
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1
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
2
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 5P9
3
London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
4
Credit Valley Hospital
Mississauga, Ontario, Canada, L5M 2N1