A Study to Determine the Antitumor Activity and Evaluate the Safety of MKC-1 - Full Text View

Sponsored by:	EntreMed
Information provided by:	EntreMed
ClinicalTrials.gov Identifier:	NCT00306631

Purpose

This phase 2 study will determine the antitumor activity, based on the objective rate, of oral MKC-1, administered twice daily for 14 consecutive days every 4 weeks, in patients with advanced or metastatic breast carcinoma. The study will also evaluate the safety and response duration in patients, time to tumor progression, and overall survival in patients following MKC-1 therapy.

Condition	Intervention	Phase
Breast Cancer	Drug: MKC-1	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Ro 31-7453

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	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

Further study details as provided by EntreMed:

Primary Outcome Measures:

Antitumor activity, based on the objective response rate [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	53
Study Start Date:	January 2006
Study Completion Date:	November 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: MKC-1 Oral capsules, 30 mg and 100 mg capsule strengths; administered twice daily for 14 days in a 28 day cycle

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306631

Locations

United States, Indiana
IUPUI
Indianapolis, Indiana, United States

Sponsors and Collaborators

EntreMed

More Information

Responsible Party:	Miikana Therapeutics, an EntreMed Company ( Carolyn Sidor, Chief Medical Officer )
Study ID Numbers:	MKC-101
Study First Received:	March 22, 2006
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00306631
Health Authority:	United States: Food and Drug Administration

Keywords provided by EntreMed:

Advanced and Metastatic Breast Cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009