Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: paclitaxel
carboplatin
custirsen
drug-drug interaction
pharmacokinetics
cancer
Lead sponsor: Achieve Life Sciences
Sponsor class: INDUSTRY
Collaborators: name: Teva Branded Pharmaceutical Products R&D, Inc.
First posted: 2011-12-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
measure: To evaluate the safety and tolerability of adding custirsen to standard paclitaxel/carboplatin chemotherapy
timeFrame: 0, 1, 2, 3, 3.25, 3.67, 4.5, 6, 8, 12, 24 and 48 hours after the start of paclitaxel infusion
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Teva Investigational Site 002
state: Michigan
city: Dallas
country: United States
facility: Teva Investigational Site 001
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 003
state: Texas
city: Tacoma
country: United States
facility: Teva Investigational Site 004
state: Washington
Study officials:
References: