Status:
COMPLETED
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
Lead Sponsor:
Achieve Life Sciences
Collaborating Sponsors:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 evalua...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01497470
Start Date
April 1 2012
End Date
October 1 2013
Last Update
October 10 2016
Active Locations (4)
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1
Teva Investigational Site 002
Detroit, Michigan, United States
2
Teva Investigational Site 001
Dallas, Texas, United States
3
Teva Investigational Site 003
San Antonio, Texas, United States
4
Teva Investigational Site 004
Tacoma, Washington, United States