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
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | April 2012 |
| End Date: | January 2013 |
| Contact: | Teva US Medical Information |
| Phone: | 800-896-5855 |
An Open-Label, One-Arm, One-Sequence Crossover Drug-Drug Interaction Study in Advanced Solid Tumor Subjects Subjects to Evaluate the Potential Effect of Custirsen (OGX-011) on the Pharmacokinetics of Paclitaxel
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.
Inclusion Criteria:
- 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 Criteria:
- 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
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