Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Custirsen, paclitaxel and carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Paclitaxel/carboplatin with custirsen
- description
- Custirsen added to standard paclitaxel/carboplatin chemotherapy
- interventionNames
- Drug: Custirsen, paclitaxel and carboplatin
Primary outcomes (1)
- measure
- To evaluate the impact of custirsen on paclitaxel pharmacokinetics
- timeFrame
- 0, 1, 2, 3, 3.25, 3.67, 4.5, 6, 8, 12, 24 and 48 hours after the start of paclitaxel infusion
- description
- The maximum peak concentration of paclitaxel after administration.
Secondary outcomes (1)
- measure
- To evaluate the safety and tolerability of adding custirsen to standard paclitaxel/carboplatin chemotherapy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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