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A Phase 2 Study of Oral MKC 1, Administered Twice Daily for 14 Consecutive Days in a 28-Day Cycle, in Patients With Unresectable or Metastatic Pancreatic Cancer Who Have Failed at Least One Prior Chemotherapy Regimen in Either the Neoadjuvant, Adjuvant, or First-line Metastatic Setting


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

Thank you

Trial Information

A Phase 2 Study of Oral MKC 1, Administered Twice Daily for 14 Consecutive Days in a 28-Day Cycle, in Patients With Unresectable or Metastatic Pancreatic Cancer Who Have Failed at Least One Prior Chemotherapy Regimen in Either the Neoadjuvant, Adjuvant, or First-line Metastatic Setting


Inclusion Criteria:



- Provide written informed consent and Health Insurance Portability and Accountability
Act authorization for release of protected health information before any study
related assessments

- Have histologically confirmed pancreatic cancer and measurable disease according to
RECIST

- Have failed at least one prior chemotherapy regimen in either the neoadjuvant,
adjuvant, or first-line metastatic setting

- Be at least 18 years of age at the time of consent

- Have an Eastern Cooperative Oncology Group performance status of 0 or 1

- Have the following laboratory results, within 10 days before the first MKC 1
administration:

1. Hemoglobin greater than or equal to 9 g/dL

2. Absolute neutrophil count greater than or equal to 1.5 x 109 cells/L

3. Platelet count greater than or equal to 75 x 109 cells/L

4. Serum creatinine less than or equal to 1.5 times the upper limit of normal (ULN)

5. Aspartate transaminase less than or equal to 2.5 times the ULN

6. Serum albumin greater than or equal to 3.0 g/dL

7. Total bilirubin less than or equal to the ULN

Exclusion Criteria:

- Be a pregnant or breast-feeding woman. Female patients must be postmenopausal,
surgically sterile, or they must agree to use a barrier method of contraception.
Female patients of childbearing potential must have a negative pregnancy test within
the 10 days before the first MKC 1 administration. Male patients must be surgically
sterile or agree to use an acceptable method of contraception.

- Have known central nervous system metastases unless they are being treated, are
clinically stable, and do not require the use of steroids.

- Have clinical evidence of significant bowel obstruction, active uncontrolled
malabsorption syndromes, or a history of total gastrectomy.

- Have uncontrolled hypercalcemia (serum calcium-corrected greater than 12 mg/dL).

- Have a serious cardiac condition (Class III/IV congestive heart failure according to
New York Heart Association classification) or documented acute myocardial infarction
within the previous 6 months.

- Have any medical conditions that, in the investigator's opinion, would impose
excessive risk to the patient. These conditions include: infection requiring
parenteral or oral anti-infective treatment or any altered mental status or any
psychiatric condition that would interfere with the understanding of the informed
consent.

- Have had 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.

- Be receiving treatment with antiretroviral therapy metabolized through CYP3A4
(including indinavir, nelfinavir, ritonavir, and saquinavir, or any other medications
that interfere with CYP3A4).

- Have, in the opinion of the investigator, any clinically significant existing
toxicities from previous chemotherapy therapies.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective tumor response rate based on tumor measurements according to the RECIST

Outcome Time Frame:

every 8 weeks

Safety Issue:

No

Principal Investigator

Eunice Kwak, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Food and Drug Administration

Study ID:

MKC-105

NCT ID:

NCT00568646

Start Date:

November 2007

Completion Date:

May 2009

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617
Dana Farber Cancer InstituteBoston, Massachusetts  02115