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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MKC-1 | Drug | Oral MKC-1 capsules, administered twice daily, for 14 consecutive days, in a 28-day cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective tumor response rate based on tumor measurements according to the RECIST | every 8 weeks |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eunice Kwak, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Dana Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21800081 | Result | 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. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| Boston |
| Massachusetts |
| 02115 |
| United States |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |