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Sponsors and Collaborators: |
Plexxikon Hoffmann-La Roche |
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Information provided by: | Plexxikon |
ClinicalTrials.gov Identifier: | NCT00405587 |
Activating mutations of the BRAF gene have been observed in a variety of cancers, including 55-68% of malignant melanomas. In general, oncogenic mutations of BRAF correlate with a poor outcome. PLX4032 is a compound that selectively inhibits oncogenic B-Raf kinase.
The primary objective of this First in Human study is to assess the safety and pharmacokinetics of PLX4032 in patients with solid tumors. The secondary objective is to assess the pharmacodynamic activity in paired biopsy specimens obtained from patients with malignant melanoma who have the V600E BRAF oncogenic mutation.
Two extension cohorts of patients with confirmed V600E mutations will be recruited, consisting of advanced melanoma and metastatic colorectal carcinoma.
Condition | Intervention | Phase |
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Malignant Melanoma Colorectal Carcinoma |
Drug: PLX4032 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Study to Assess Safety, Pharmacokinetics, and Pharmacodynamics of PLX4032 in Patients With Solid Tumors |
Estimated Enrollment: | 75 |
Study Start Date: | November 2006 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All patients enrolled must provide archival or fresh melanoma tumor biopsy for confirmation of V600E+ BRAF mutation status by TaqMan assay
Exclusion Criteria:
United States, California | |
University of California Los Angeles | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Glaucia Vasquez, RN 310-825-0313 gavasquez@mednet.ucla.edu | |
Principal Investigator: Antoni Ribas, MD | |
Principal Investigator: Randy Hecht, MD | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Christine Ferrari, R.N. 646-497-9053 | |
Principal Investigator: Paul Chapman, M.D. | |
Principal Investigator: Len Saltz, M.D. | |
United States, Pennsylvania | |
University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: MaryAnn Redlinger, RN 215-662-7452 maryann.redlinger@uphs.upenn.edu | |
Principal Investigator: Keith Flaherty, M.D. | |
Principal Investigator: Peter O'Dwyer, MD | |
United States, Tennessee | |
Vanderbilt Ingram Cancer Center | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: Cancer Information Program 800-811-8480 | |
Principal Investigator: Igor Puzanov, MD | |
Principal Investigator: Emily Chan, M.D. | |
United States, Texas | |
MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Laura Henry, RN 713-742-7317 | |
Principal Investigator: Kevin Kim, MD | |
Principal Investigator: Scott Kopetz, M.D. | |
Australia, Victoria | |
Peter MacCallum Cancer Centre | Recruiting |
East Melbourne, Victoria, Australia, 3002 | |
Contact: Grant McArthur, MB BS +61-3-9656-1954 | |
Principal Investigator: Grant McArthur, MB BS | |
Royal Melbourne Hospital | Recruiting |
Parkville, Victoria, Australia | |
Contact: Jayesh Desai, MD 61-3-9342-7560 | |
Principal Investigator: Jayesh Desai, MD |
Responsible Party: | Plexxikon Inc. ( Keith Nolop, MD ) |
Study ID Numbers: | PLX06-02 |
Study First Received: | November 28, 2006 |
Last Updated: | June 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00405587 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms Melanoma Carcinoma Neuroendocrine Tumors |
Neuroectodermal Tumors Digestive System Diseases Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma Gastrointestinal Neoplasms Nevus Colorectal Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Digestive System Neoplasms Gastrointestinal Diseases Neoplasms, Nerve Tissue Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms Neuroendocrine Tumors Carcinoma |
Melanoma Neuroectodermal Tumors Neoplasms Neoplasms by Site Digestive System Diseases Neoplasms, Germ Cell and Embryonal Gastrointestinal Neoplasms Nevi and Melanomas Colorectal Neoplasms Neoplasms, Glandular and Epithelial |