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

Achieve Life Sciences

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: Custirsen, paclitaxel and carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01497470

TV1011-DDI-105

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

36 participants in 1 patient group

Paclitaxel/carboplatin with custirsen

Experimental group

Description:

Custirsen added to standard paclitaxel/carboplatin chemotherapy

Treatment:

Drug: Custirsen, paclitaxel and carboplatin