Phase 2 Study of Oral MKC-1 in Patients With Unresectable or Metastatic Pancreatic Cancer

NCT00568646 | Completed Phase 2

• 1 other identifier: MKC-105
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

Brief Summary

To determine the antitumor activity of MKC-1 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

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

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

  every 8 weeks

Study Arms (1)

1

EXPERIMENTAL

Drug: MKC-1

Interventions

MKC-1 DRUG

Oral MKC-1 capsules, administered twice daily, for 14 consecutive days, in a 28-day cycles

1

Eligibility Criteria

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

You may qualify if:

• 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:
• Hemoglobin greater than or equal to 9 g/dL
• Absolute neutrophil count greater than or equal to 1.5 x 109 cells/L
• Platelet count greater than or equal to 75 x 109 cells/L
• Serum creatinine less than or equal to 1.5 times the upper limit of normal (ULN)
• Aspartate transaminase less than or equal to 2.5 times the ULN
• Serum albumin greater than or equal to 3.0 g/dL
• Total bilirubin less than or equal to the ULN

You may not qualify if:

• 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.

Sponsors & Collaborators

• CASI Pharmaceuticals, Inc.: lead

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Faris JE, Arnott J, Zheng H, Ryan DP, Abrams TA, Blaszkowsky LS, Clark JW, Enzinger PC, Hezel AF, Ng K, Wolpin BM, Kwak EL. A phase 2 study of oral MKC-1, an inhibitor of importin-beta, tubulin, and the mTOR pathway in patients with unresectable or metastatic pancreatic cancer. Invest New Drugs. 2012 Aug;30(4):1614-20. doi: 10.1007/s10637-011-9708-3. Epub 2011 Jul 29.

  PMID: 21800081 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Eunice Kwak, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 4, 2007
• First Posted: December 6, 2007
• Study Start: November 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: August 4, 2011

Record last verified: 2011-08

Locations

US (2)