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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cancer

Intervention / Treatment
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* Drug: Custirsen, paclitaxel and carboplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel/carboplatin with custirsen<br>Custirsen added to standard paclitaxel/carboplatin chemotherapy | Drug: Custirsen, paclitaxel and carboplatin<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the impact of custirsen on paclitaxel pharmacokinetics | The maximum peak concentration of paclitaxel after administration. | 0, 1, 2, 3, 3.25, 3.67, 4.5, 6, 8, 12, 24 and 48 hours after the start of paclitaxel infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of adding custirsen to standard paclitaxel/carboplatin chemotherapy |  | 0, 1, 2, 3, 3.25, 3.67, 4.5, 6, 8, 12, 24 and 48 hours after the start of paclitaxel infusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paclitaxel, carboplatin, custirsen, drug-drug interaction, pharmacokinetics, cancer