TRIAL DETAIL
Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM060184 in Combination With Gemcitabine in Selected Patients With Advanced Solid Tumors
Drug: |
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Trial Name: |
Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM060184 in Combination With Gemcitabine in Selected Patients With Advanced Solid Tumors |
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NCT#: |
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Conditions: |
Gastrointestinal Stromal Tumor |
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Status: |
Ongoing, but not recruiting |
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Phase: |
1 |
Start Date 12/01/2014 |
Age of Trial (yrs) 9.4 |
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Treatment Phase: |
Gleevec-resistant |
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Drug Category: |
Tubulin inhibotor + Chemotherapy |
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Strategy: |
Inhibit Tubulin and limit DNA replication |
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Trial Type: |
Specifically GIST plus other cancers |
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Other Protocol IDs: |
PM60184-A-003-14
EudraCT 2014-002943-16 |
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Sponsor: |
PharmaMar |
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Patient Contact: |
Cinthya Coronado, MD clinicaltrials@pharmamar.com |
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Contact email: |
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Contact Phone: |
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Randomized: |
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IV or Oral: |
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Trial Notes: |
Brief Summary: Prospective, open-label, dose-ranging, uncontrolled phase I study with escalating doses of PM060184 in combination with gemcitabine in selected patients with advanced solid tumors. The study objectives are: To determine the MTD and the RD of PM060184 in combination with gemcitabine in selected patients with advanced solid tumors. To characterize the safety profile and feasibility of this combination in this study population. To characterize the pharmacokinetics of this combination and to detect major drug-drug PK interactions. To obtain preliminary information on the clinical antitumor activity of this combination. |
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Trial Links |
Trial Results |
Drug Information |
Trial Sites
Name |
Address |
City |
State |
Zip |
Country |
Madrid |
Spain |
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111 East 210th St. |
Bronx |
NY |
10467 |
USA |