Dasatinib, Bevacizumab, Paclitaxel in Patients With Advanced Malignancies
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|ClinicalTrials.gov Identifier: NCT01015222|
Recruitment Status : Active, not recruiting
First Posted : November 18, 2009
Last Update Posted : May 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer||Drug: Dasatinib Drug: Bevacizumab Drug: Paclitaxel||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||218 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Dasatinib (Src Inhibitor), Bevacizumab (Anti-VEGF Monoclonal Antibody) and Metronomic Paclitaxel + or - Methylnaltrexone in Patients With Advanced Malignancies|
|Actual Study Start Date :||November 2009|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2021|
Experimental: Dasatinib, Bevacizumab + Paclitaxel
Dose Escalation Starting Dose Levels: 50 mg Dasatinib daily by mouth (PO), 5 mg/kg Bevacizumab IV on Day 1 and 15; Paclitaxel 40 mg/m2 IV on Day 1, 8 and 15
Dose Expansion Starting Dose Levels: Maximum tolerated dose from Dose Escalation.
Starting dose of 50 mg daily PO for 28 day cycle
Starting dose 5 mg/kg IV Day 1 and 15
Starting dose 40 mg/m2 IV Day 1, 8 and 15
Other Name: Taxol
- Maximum Tolerated Dose (MTD) of Dasatinib, Bevacizumab and Paclitaxel + or - Methylnaltrexone in Advanced or Metastatic Cancer That is Refractory to Standard Treatment [ Time Frame: Continuous assessment during each dose level/28-day cycle ]MTD defined as the highest dose below any dose that has one third or more patients with dose limiting toxicities (DLT).
- Antitumor Efficacy of the Combination of Dasatinib, Bevacizumab and Paclitaxel + or - Methylnaltrexone in Advanced or Metastatic Cancer That is Refractory to Standard Treatment [ Time Frame: 28 days after the last dose of study drugs ]Participants with lymphoma measured per the WHO criteria, and all others evaluated using RECIST criteria version 1.1.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01015222
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Filip Janku, MD,PHD||M.D. Anderson Cancer Center|