A Clinical Study in Cancer Patients to Investigate the Potential Impact of Custirsen, on the Blood Levels of the Chemotherapeutic Drug, Paclitaxel, When Given Together as Part of a Treatment Regimen

Completed · Phase 1

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT01497470

Run by

Achieve Life Sciences

People needed

36

Starts

2012-04-01

Expected to finish

2013-10-01

Last updated by the study team

2016-10-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of a solid tumor that is refractory to standard therapies and is not amenable to treatment with established curative or palliative therapies and for whom paclitaxel and carboplatin is deemed an acceptable treatment by the investigator
• Males or females ≥18 years of age
• Life expectancy of ≥12 weeks
• Minimum of 1 lesion
• ECOG performance status of 0, 1 or 2
• Adequate bone marrow reserve
• Adequate renal and liver function

You may not qualify if…

• Brain metastases that are symptomatic or require ongoing treatment
• Major trauma or surgery within last 2 months, acute infection within 2 weeks (14 days), or radiotherapy, chemotherapy, immunotherapy or hormonal therapy within past 4 weeks
• Persistent grade 2 or greater toxicity related to prior therapy
• Grade 2 or greater peripheral neuropathy
• Recent or current use of Cyp3A4, Cyp2C8 or P-gp inhibitors
• Recent or current use of CYP enzyme inducers

Where it is running

• Teva Investigational Site 002 — Detroit, Michigan, United States
• Teva Investigational Site 001 — Dallas, Texas, United States
• Teva Investigational Site 003 — San Antonio, Texas, United States
• Teva Investigational Site 004 — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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