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A Phase 2 Study of Oral MKC-1 Administered Twice Daily for 14 Consecutive Days Every 4 Weeks in Patients With Advanced or Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

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Trial Information

A Phase 2 Study of Oral MKC-1 Administered Twice Daily for 14 Consecutive Days Every 4 Weeks in Patients With Advanced or Metastatic Breast Cancer


Inclusion Criteria:



- Histologically or cytologically confirmed advanced or metastatic adenocarcinoma of
the breast

- 18 years or older

- Karnofsky performance status greater than or equal to 70%

- Radiographic or physical examination evidence of at least one site of
unidimensionally-measurable disease, using the Response Evaluation Criteria in Solid
Tumors (RECIST) criteria

- Must have failed both a taxane and an anthracycline, given sequentially or in
combination, either in an adjuvant or metastatic setting

- All acute toxicity of any prior chemotherapy, surgery or radiotherapy must have
resolved to National Cancer Institute Common Toxicity Criteria (NCI CTC) Grade less
than or equal to 1

- Lab results, within 10 days of MKC-1 administration:

- Hemoglobin less than or equal to 9 g/dL

- Absolute neutrophil count greater than or equal to 1.5 x 10^9/L

- Platelet count greater than or equal to 75 x 10^9/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 LLN (lower limit of normal)

- Total bilirubin less than or equal to ULN

- Alkaline phosphatase less than or equal to 2.5 x ULN

- Signed informed consent

Exclusion Criteria:

- Pre-existing hepatomegaly with disease measures greater than or equal to 2 cm below
the costal margin, secondary to malignancy

- 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

- Be pregnant or lactating; not employing effective birth control

- Known central nervous system (CNS) metastases unless treated, clinically stable and
not requiring steroids

- Clinical evidence of bowel obstruction, active uncontrolled malabsorption syndromes
or a history of total gastrectomy

- Administration of any investigational agent (therapeutic or diagnostic) within 4
weeks prior to receipt of study medication

- Uncontrolled hypercalcemia (serum calcium-corrected greater than 12 mg/dL)

- Serious cardiac condition

- Any medical conditions that, in the investigator's opinion would impose excessive
risk to the patient

- Patients with previous malignancies unless free of recurrence for at least 5 years
except basal cell carcinoma of the skin or carcinoma-in-situ of the uterine cervix

- Treatment with antiretroviral therapy metabolized through CYP3A4

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity, based on the objective response rate

Outcome Time Frame:

every 8 weeks

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

MKC-101

NCT ID:

NCT00306631

Start Date:

January 2006

Completion Date:

November 2008

Related Keywords:

  • Breast Cancer
  • Advanced and Metastatic Breast Cancer
  • Breast Neoplasms

Name

Location

IUPUIIndianapolis, Indiana