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

NCT00607607 | Completed Phase 2

• 1 other identifier: MKC-103
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 6

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.

Conditions

Ovarian Cancer; Endometrial Cancer

Keywords

ovarian cancer; endometrial cancer

Outcome Measures

Primary Outcomes (1)

• Tumor response rate (based on tumor measurements according to the RECIST criteria) or CA-125

  Every 4 to 8 weeks

Secondary Outcomes (2)

• Time to progression

  Time of progression

• Adverse events spontaneously declared by the patients or noted during physical examination and laboratory tests.

  As reported

Study Arms (2)

A

EXPERIMENTAL

Ovarian Cancer Patients

Drug: MKC-1

B

EXPERIMENTAL

Endometrial Cancer Patients

Drug: MKC-1

Interventions

MKC-1 DRUG

capsules, provided 125 mg/m2 BID x 14 days in 28 day cycles

A; B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• CASI Pharmaceuticals, Inc.: lead

Study Sites (6)

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, K7L 5P9, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Credit Valley Hospital

Mississauga, Ontario, L5M 2N1, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Hopital Notre-Dame du CHUM

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases

Study Officials

• Amit Oza, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: February 6, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: January 1, 2012
• Last Updated: January 20, 2012

Record last verified: 2012-01

Locations

CA (6)