A Phase 1 interventional study of Custirsen, paclitaxel and carboplatin in Cancer, sponsored by Achieve Life Sciences. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-10.
Sponsored by Achieve Life Sciences · Phase 1 and Interventional
The primary goal of this study is to determine if custirsen has an effect on the way the body distributes and gets rid of paclitaxel, the standard administered chemotherapy. The study will also evaluate if custirsen influences the way the body distributes and gets rid of carboplatin (another standard administered chemotherapy) and will measure custirsen blood levels in this cancer population. Finally, the study will evaluate the safety and tolerability of adding custirsen to the standard paclitaxel/carboplatin chemotherapy.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's enrollment of 36 is below the median of 50 across 7,429 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Achieve Life Sciences is the lead sponsor of 31 studies on the registry; 1 is open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 8 (67%) have results posted.
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Custirsen added to standard paclitaxel/carboplatin chemotherapy
Drug: Custirsen, paclitaxel and carboplatin
Drug pages: OGX-011 · Paclitaxel · Carboplatin
Custirsen (640 mg IV over 2 hours) will be administered weekly on Days 1, 8, and 15 of each 21 day cycle. Paclitaxel (200 mg/m2 IV over 3 hours) and carboplatin (AUC 6.0 mg/mL/min IV over 30 minutes) will be administered on Day 1 of each 21 day cycle
To evaluate the impact of custirsen on paclitaxel pharmacokinetics
The maximum peak concentration of paclitaxel after administration.
Time frame: 0, 1, 2, 3, 3.25, 3.67, 4.5, 6, 8, 12, 24 and 48 hours after the start of paclitaxel infusion
To evaluate the safety and tolerability of adding custirsen to standard paclitaxel/carboplatin chemotherapy
Time frame: 0, 1, 2, 3, 3.25, 3.67, 4.5, 6, 8, 12, 24 and 48 hours after the start of paclitaxel infusion
The record gives a start of Apr 2012, a primary completion of Jul 2013 and a completion of Oct 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: OGX-011 · Paclitaxel · Carboplatin