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NCT Number: NCT01497470

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Teva Investigational Site 002, Detroit, Michigan, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Custirsen, paclitaxel and carboplatin

Drug

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

Primary outcomes

  1. To evaluate the impact of custirsen on paclitaxel pharmacokinetics

    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

    The maximum peak concentration of paclitaxel after administration.

Secondary outcomes

  1. To evaluate the safety and tolerability of adding custirsen to standard paclitaxel/carboplatin chemotherapy

    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

Sponsors and collaborators

Lead sponsor

Achieve Life Sciences

Industry

Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 22, 2011
Registry last updated
Oct 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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