Brief Title
A Phase 2 Study of Oral MKC-1 in Patients With Ovarian or Endometrial Cancer
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
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 stratified to Arm A (ovarian cancer) or Arm B (endometrial cancer), and will receive
identical treatment regimens.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Tumor response rate (based on tumor measurements according to the RECIST criteria) or CA-125
Secondary Outcome
Time to progression
Condition
Ovarian Cancer
Intervention
MKC-1
Study Arms / Comparison Groups
A
Description: Ovarian Cancer Patients
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
44
Start Date
January 2008
Completion Date
January 2012
Primary Completion Date
June 2011
Eligibility 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).
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Amit Oza, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT00607607
Organization ID
MKC-103
Study Sponsor
CASI Pharmaceuticals, Inc.
Study Sponsor
Amit Oza, MD, Principal Investigator, Princess Margaret Hospital, Canada
Verification Date
January 2012