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

• Paclitaxel Maximum Observed Plasma Concentration (Cmax) [ 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 ] [ Designated as safety issue: No ]
  Paclitaxel Cmax on Period 3 (test treatment) vs. Paclitaxel Cmax on Period 1 (reference treatment)
• Paclitaxel Area Under the Curve from Time Zero to Last Quantifiable Concentration [AUC(0-t)] [ 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 ] [ Designated as safety issue: No ]
  Paclitaxel AUC(0-t) on Period 3 (test treatment) vs. Paclitaxel AUC(0-t) on Period 1 (reference treatment)
• Paclitaxel Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-∞)] [ 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 ] [ Designated as safety issue: No ]
  Paclitaxel AUC(0-∞) on Period 3 (test treatment) vs. Paclitaxel AUC(0-∞) on Period 1 (reference treatment)

• Carboplatin Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 2.83, 4.83, 8.83 and 20.83 hours after the start of carboplatin infusion ] [ Designated as safety issue: No ]
  Carboplatin Cmax on Period 3 (test treatment) vs. Carboplatin Cmax on Period 1 (reference treatment)
• Carboplatin Area Under the Curve from Time Zero to Last Quantifiable Concentration [AUC(0-t)] [ Time Frame: 0, 0.5, 2.83, 4.83, 8.83 and 20.83 hours after the start of carboplatin infusion ] [ Designated as safety issue: No ]
  Carboplatin AUC(0-t) on Period 3 (test treatment) vs. carboplatin AUC(0-t) on Period 1 (reference treatment)
• Custirsen Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 2, 3.17, 4.17, 5.17, 8.17, 14.17, 26.17 and 50.17 hours after the start of custirsen infusion ] [ Designated as safety issue: No ]
  Custirsen Cmax on Period 3 (test treatment)

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