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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01497470

Enrollment

Registered

2011-12-22

Start date

2012-04-30

Completion date

2013-10-31

Last updated

2016-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

paclitaxel, carboplatin, custirsen, drug-drug interaction, pharmacokinetics, cancer

Brief summary

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.

Interventions

DRUGCustirsen, paclitaxel and carboplatin

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the impact of custirsen on paclitaxel pharmacokinetics	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026